Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults with Major Depressive Disorder, the Orion Trial

    Summary
    EudraCT number
    		 2011-001351-37
    Trial protocol
    		 HU   DE   SK  
    Global end of trial date
    18 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jun 2018
    First version publication date
    23 Jun 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    331-10-238
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01360866
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Otsuka Pharmaceutical Development & Commercialization, Inc.
    Sponsor organisation address
    2440 Research Boulevard, Rockville, United States, MD 20850
    Public contact
    Mary Hobart, PhD Senior Director, Global Clinical Development Phone: (240) 683-3194 Fax: (240) 76, Otsuka Transparency Department, Otsuka Pharmaceutical Development & Commercialization, Inc., 44 1628581161, gtrewartha@INCResearch.com
    Scientific contact
    Mary Hobart, PhD Senior Director, Global Clinical Development Phone: (240) 683-3194 Fax: (240) 76, Otsuka Transparency Department, Otsuka Pharmaceutical Development & Commercialization, Inc., DT-inq, 44 1628581161, gtrewartha@INCResearch.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    18 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the long-term safety and tolerability of oral brexpiprazole (OPC-34712) as adjunctive therapy in the treatment of adults with major depressive disorder (MDD).
    Protection of trial subjects
    This trial was conducted in compliance with Good Clinical Practice guidelines for conducting, recording, and reporting trials, as well as for archiving essential documents. Consistent with ethical principles for the protection of human research subjects, no trial procedures were performed on trial candidates until written consent or assent had been obtained from them and/or their legally acceptable representative. The informed consent form, protocol, and amendments for this trial were submitted to and approved by the Institutional Review Board or Independent Ethics Committee at each respective trial center.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Oct 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 50
    Country: Number of subjects enrolled
    France: 156
    Country: Number of subjects enrolled
    Germany: 160
    Country: Number of subjects enrolled
    Hungary: 36
    Country: Number of subjects enrolled
    Poland: 312
    Country: Number of subjects enrolled
    Romania: 15
    Country: Number of subjects enrolled
    Russian Federation: 351
    Country: Number of subjects enrolled
    Serbia: 86
    Country: Number of subjects enrolled
    Slovakia: 12
    Country: Number of subjects enrolled
    Ukraine: 67
    Country: Number of subjects enrolled
    United States: 1699
    Worldwide total number of subjects
    2944
    EEA total number of subjects
    691
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    2932
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This trial was conducted in 2944 participants at 188 sites in the following 11 countries: Canada, France, Germany, Hungary, Poland, Romania, Russian Federation, Serbia, Slovakia, Ukraine, and United States (US).

    Pre-assignment
    Screening details
    		 Participants who completed the last schedule visit of one of the double-blind, phase 3 brexpiprazole MDD trials (Trials 331-10-227, 331-10-228, and 331-12-282) and who, in investigator's judgment, could potentially benefit from adjunctive treatment with oral brexpiprazole. Participants signed a separate informed consent form for 331-10-238.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prior Placebo
    Arm description
    		 Participants who had received placebo with antidepressant therapy [ADT] in previous double blind phase 3 studies. In this study, participants received brexpiprazole.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brexpiprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The first dose of open-label brexpiprazole was taken one day after the last dose was taken for the prior double-blind, phase 3 efficacy trial so that adjunctive treatment continued without interruption. Participants initiated open-label dosing with brexpiprazole 0.5 mg/day for 1 Week. Participants unable to tolerate brexpiprazole 0.5 mg/day were withdrawn from the trial. The dose of brexpiprazole was increased to 1 mg/day at the Week 1 visit. Participants unable to tolerate brexpiprazole 1 mg/day may have decreased to 0.5 mg/day at any time after the Week 1 visit. Investigators might have further increased the dose to brexpiprazole 2 mg/day and then to brexpiprazole 3 mg/day, with an interval of at least 5 days between dose increases. An interval of at least 5 days between dose adjustments was recommended for dose decrease. During the Treatment Phase of Trial 331-10-238, participants remained on the same assigned open-label ADT from the prior double-blind, phase 3 efficacy trial.

    Arm title
    		 Prior Brexpiprazole
    Arm description
    		 Participants who had received Brexpiprazole with antidepressant therapy [ADT] in previous double blind phase 3 studies. In this study, participants received brexpiprazole.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brexpiprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The first dose of open-label brexpiprazole was taken one day after the last dose was taken for the prior double-blind, phase 3 efficacy trial so that adjunctive treatment continued without interruption. Participants initiated open-label dosing with brexpiprazole 0.5 mg/day for 1 Week. Participants unable to tolerate brexpiprazole 0.5 mg/day were withdrawn from the trial. The dose of brexpiprazole was increased to 1 mg/day at the Week 1 visit. Participants unable to tolerate brexpiprazole 1 mg/day may have decreased to 0.5 mg/day at any time after the Week 1 visit. Investigators might have further increased the dose to brexpiprazole 2 mg/day and then to brexpiprazole 3 mg/day, with an interval of at least 5 days between dose increases. An interval of at least 5 days between dose adjustments was recommended for dose decrease. During the Treatment Phase of Trial 331-10-238, participants remained on the same assigned open-label ADT from the prior double-blind, phase 3 efficacy trial.

    Arm title
    		 Prior ADT
    Arm description
    		 Participants who had received only antidepressant therapy [ADT] in previous double blind phase 3 studies. In this study, participants received brexpiprazole.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brexpiprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The first dose of open-label brexpiprazole was taken one day after the last dose was taken for the prior double-blind, phase 3 efficacy trial so that adjunctive treatment continued without interruption. Participants initiated open-label dosing with brexpiprazole 0.5 mg/day for 1 Week. Participants unable to tolerate brexpiprazole 0.5 mg/day were withdrawn from the trial. The dose of brexpiprazole was increased to 1 mg/day at the Week 1 visit. Participants unable to tolerate brexpiprazole 1 mg/day may have decreased to 0.5 mg/day at any time after the Week 1 visit. Investigators might have further increased the dose to brexpiprazole 2 mg/day and then to brexpiprazole 3 mg/day, with an interval of at least 5 days between dose increases. An interval of at least 5 days between dose adjustments was recommended for dose decrease. During the Treatment Phase of Trial 331-10-238, participants remained on the same assigned open-label ADT from the prior double-blind, phase 3 efficacy trial.

    Arm title
    		 Prior Seroquel
    Arm description
    		 Participants who had received Seroquel with ADT in previous double blind phase 3 studies. In this study, participants received brexpiprazole.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brexpiprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The first dose of open-label brexpiprazole was taken one day after the last dose was taken for the prior double-blind, phase 3 efficacy trial so that adjunctive treatment continued without interruption. Participants initiated open-label dosing with brexpiprazole 0.5 mg/day for 1 Week. Participants unable to tolerate brexpiprazole 0.5 mg/day were withdrawn from the trial. The dose of brexpiprazole was increased to 1 mg/day at the Week 1 visit. Participants unable to tolerate brexpiprazole 1 mg/day may have decreased to 0.5 mg/day at any time after the Week 1 visit. Investigators might have further increased the dose to brexpiprazole 2 mg/day and then to brexpiprazole 3 mg/day, with an interval of at least 5 days between dose increases. An interval of at least 5 days between dose adjustments was recommended for dose decrease. During the Treatment Phase of Trial 331-10-238, participants remained on the same assigned open-label ADT from the prior double-blind, phase 3 efficacy trial.

    Number of subjects in period 1
    		Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
    Started
    516
    707
    1645
    76
    Completed
    295
    420
    1126
    54
    Not completed
    221
    287
    519
    22
         Withdrawn by Investigator
    9
    8
    31
    2
         Lack of Efficacy
    30
    40
    30
    4
         Adverse Event
    56
    61
    134
    6
         Protocol Deviation
    25
    33
    61
    2
         Withdrawal by participant
    79
    89
    168
    8
         Lost to follow-up
    11
    28
    41
    -
         Paticipant met withdrawal criteria
    11
    28
    54
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Prior Placebo
    Reporting group description
    		 Participants who had received placebo with antidepressant therapy [ADT] in previous double blind phase 3 studies. In this study, participants received brexpiprazole.

    Reporting group title
    Prior Brexpiprazole
    Reporting group description
    		 Participants who had received Brexpiprazole with antidepressant therapy [ADT] in previous double blind phase 3 studies. In this study, participants received brexpiprazole.

    Reporting group title
    Prior ADT
    Reporting group description
    		 Participants who had received only antidepressant therapy [ADT] in previous double blind phase 3 studies. In this study, participants received brexpiprazole.

    Reporting group title
    Prior Seroquel
    Reporting group description
    		 Participants who had received Seroquel with ADT in previous double blind phase 3 studies. In this study, participants received brexpiprazole.

    Reporting group values
    		 Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel Total
    Number of subjects
    		 516 707 1645 76 2944
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.0 ( 11.0 ) 45.0 ( 11.0 ) 44.0 ( 12.0 ) 44.0 ( 11.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 367 479 1108 51 2005
        Male
    		 149 228 537 25 939

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Prior Placebo
    Reporting group description
    		 Participants who had received placebo with antidepressant therapy [ADT] in previous double blind phase 3 studies. In this study, participants received brexpiprazole.

    Reporting group title
    Prior Brexpiprazole
    Reporting group description
    		 Participants who had received Brexpiprazole with antidepressant therapy [ADT] in previous double blind phase 3 studies. In this study, participants received brexpiprazole.

    Reporting group title
    Prior ADT
    Reporting group description
    		 Participants who had received only antidepressant therapy [ADT] in previous double blind phase 3 studies. In this study, participants received brexpiprazole.

    Reporting group title
    Prior Seroquel
    Reporting group description
    		 Participants who had received Seroquel with ADT in previous double blind phase 3 studies. In this study, participants received brexpiprazole.

    Primary: Adverse Events (AEs) - Number of participants with AEs

    		 Close Top of page
    End point title
    		 Adverse Events (AEs) - Number of participants with AEs [1]
    End point description
    The primary outcome variable was the safety and tolerability of brexpiprazole, which was assessed by examining the frequency and severity of adverse events (AEs).
    End point type
    Primary
    End point timeframe
    From screening to week 52/early termination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistical analysis was done.
    End point values
    		 Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
    Number of subjects analysed
    516
    706
    1640
    76
    Units: Participants
        Participants with adverse events
    400
    511
    1165
    51
        Participants with treatment emergent AE (TEAE)
    399
    510
    1163
    51
        Participants with serious TEAE
    14
    23
    33
    1
        Participants with severe TEAE
    48
    64
    99
    4
        Partcipants discontinued due to AE
    55
    58
    134
    6
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness scale Score

    		 Close Top of page
    End point title
    		 Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness scale Score
    End point description
    The severity of illness for each participant was rated using the CGI-S .The investigator was answered the following question: "Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
    End point type
    Secondary
    End point timeframe
    From screening to week 52/early termination
    End point values
    		 Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
    Number of subjects analysed
    512
    698
    1630
    76
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -0.77 ( 1.11 )
    -0.63 ( 1.16 )
    -0.48 ( 1.04 )
    -0.93 ( 0.85 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score

    		 Close Top of page
    End point title
    		 Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score
    End point description
    The efficacy of trial treatment was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant's condition at screening/Baseline (i.e., last scheduled visit of the prior double-blind phase 3 trial). Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse.
    End point type
    Secondary
    End point timeframe
    From screening to week 52/early termination
    End point values
    		 Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
    Number of subjects analysed
    505
    693
    1606
    75
    Units: Units on a scale
        arithmetic mean (standard deviation)
    2.60 ( 1.30 )
    2.63 ( 1.34 )
    2.63 ( 1.39 )
    2.40 ( 1.17 )
    No statistical analyses for this end point

    Secondary: Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score

    		 Close Top of page
    End point title
    		 Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score
    End point description
    The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on regular life responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains with 0 = not at all, to 10 = extremely. Scores of 5 and above were associated with significant functional impairment.
    End point type
    Secondary
    End point timeframe
    From screening to week 52/early termination
    End point values
    		 Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
    Number of subjects analysed
    346
    457
    1165
    53
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -0.80 ( 2.80 )
    -0.70 ( 2.60 )
    -0.40 ( 2.30 )
    -1.00 ( 1.70 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Inventory of Depressive Symptomatology (Self-report) Total Score

    		 Close Top of page
    End point title
    		 Change From Baseline in the Inventory of Depressive Symptomatology (Self-report) Total Score
    End point description
    The inventory of depressive symptomatology - self report (IDS-SR) was a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of MDD.
    End point type
    Secondary
    End point timeframe
    From screening to week 52/early termination
    End point values
    		 Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
    Number of subjects analysed
    491
    664
    1556
    75
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -5.25 ( 12.21 )
    -4.76 ( 11.79 )
    -3.94 ( 10.57 )
    -7.44 ( 8.89 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Prior Placebo
    Reporting group description
    		 Participants who received placebo with antidepressant therapy [ADT] in previous double blind phase 3 studies.

    Reporting group title
    Prior Brexpiprazole
    Reporting group description
    		 Participants who received Brexpiprazole with antidepressant therapy [ADT] in previous double blind phase 3 studies.

    Reporting group title
    Prior ADT
    Reporting group description
    		 Participants who received only antidepressant therapy [ADT] in previous double blind phase 3 studies.

    Reporting group title
    Prior Seroquel
    Reporting group description
    		 Participants who received Seroquel with antidepressant therapy [ADT] in previous double blind phase 3 studies.

    Serious adverse events
    		 Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 516 (2.71%)
    23 / 706 (3.26%)
    33 / 1640 (2.01%)
    1 / 76 (1.32%)
         number of deaths (all causes)
    2
    2
    0
    0
         number of deaths resulting from adverse events
    2
    2
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast Cancer
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraductal Proliferative Breast Lesion
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian Cancer
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic Neuroendocrine Tumour
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal Adenocarcinoma
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 706 (0.00%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal Cell Carcinoma
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    2 / 1640 (0.12%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug Withdrawal Syndrome
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic Adhesions
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    2 / 516 (0.39%)
    1 / 706 (0.14%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed Suicide
         subjects affected / exposed
    0 / 516 (0.00%)
    2 / 706 (0.28%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    2 / 516 (0.39%)
    3 / 706 (0.42%)
    3 / 1640 (0.18%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depressive Symptom
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional Self-Injury
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major Depression
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    2 / 516 (0.39%)
    1 / 706 (0.14%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Electrocardiogram Qt Prolonged
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional Overdose
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Patella Fracture
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Aortic Valve Incompetence
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular Dysfunction
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular Accident
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    2 / 1640 (0.12%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyskinesia
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extrapyramidal Disorder
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar Radiculopathy
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 706 (0.00%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ruptured Cerebral Aneurysm
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 706 (0.00%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Iron Deficiency Anaemia
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Blepharospasm
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal Vein Thrombosis
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn's Disease
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric Ulcer Perforation
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 706 (0.00%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    2 / 1640 (0.12%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis Acute
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal Disorder
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral Disc Protrusion
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 706 (0.00%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar Spinal Stenosis
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    0 / 1640 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal Osteoarthritis
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 706 (0.00%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    0 / 1640 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kidney Infection
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 516 (0.19%)
    0 / 706 (0.00%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 516 (0.00%)
    1 / 706 (0.14%)
    0 / 1640 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    0 / 516 (0.00%)
    0 / 706 (0.00%)
    1 / 1640 (0.06%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    296 / 516 (57.36%)
    323 / 706 (45.75%)
    787 / 1640 (47.99%)
    33 / 76 (43.42%)
    Investigations
    Weight Increased
         subjects affected / exposed
    118 / 516 (22.87%)
    100 / 706 (14.16%)
    296 / 1640 (18.05%)
    5 / 76 (6.58%)
         occurrences all number
    126
    103
    312
    5
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    54 / 516 (10.47%)
    37 / 706 (5.24%)
    99 / 1640 (6.04%)
    7 / 76 (9.21%)
         occurrences all number
    60
    41
    109
    8
    Headache
         subjects affected / exposed
    42 / 516 (8.14%)
    55 / 706 (7.79%)
    105 / 1640 (6.40%)
    9 / 76 (11.84%)
         occurrences all number
    52
    74
    126
    9
    Somnolence
         subjects affected / exposed
    40 / 516 (7.75%)
    60 / 706 (8.50%)
    130 / 1640 (7.93%)
    5 / 76 (6.58%)
         occurrences all number
    43
    65
    137
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    37 / 516 (7.17%)
    50 / 706 (7.08%)
    88 / 1640 (5.37%)
    3 / 76 (3.95%)
         occurrences all number
    40
    57
    101
    3
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    14 / 516 (2.71%)
    15 / 706 (2.12%)
    33 / 1640 (2.01%)
    4 / 76 (5.26%)
         occurrences all number
    14
    17
    34
    4
    Nausea
         subjects affected / exposed
    26 / 516 (5.04%)
    32 / 706 (4.53%)
    61 / 1640 (3.72%)
    4 / 76 (5.26%)
         occurrences all number
    29
    37
    63
    5
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    39 / 516 (7.56%)
    37 / 706 (5.24%)
    76 / 1640 (4.63%)
    0 / 76 (0.00%)
         occurrences all number
    44
    45
    89
    0
    Insomnia
         subjects affected / exposed
    30 / 516 (5.81%)
    40 / 706 (5.67%)
    108 / 1640 (6.59%)
    6 / 76 (7.89%)
         occurrences all number
    30
    45
    125
    6
    Infections and infestations
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    25 / 516 (4.84%)
    35 / 706 (4.96%)
    98 / 1640 (5.98%)
    2 / 76 (2.63%)
         occurrences all number
    26
    40
    105
    2
    Metabolism and nutrition disorders
    Increased Appetite
         subjects affected / exposed
    37 / 516 (7.17%)
    28 / 706 (3.97%)
    117 / 1640 (7.13%)
    3 / 76 (3.95%)
         occurrences all number
    37
    29
    123
    4

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Nov 2011
    Amendment 1: Clarification of trial procedures, administrative changes, and correction of typographical errors.
    16 Nov 2012
    Amendment 2: Allow enrollment of eligible participants who completed the last scheduled visit of a double-blind phase 3 brexpiprazole MDD trial, to remove the definitions of incomplete response and response, to match the specifications for potential Hy’s Law cases, to clarify that the contraceptive methods of vasectomy and tubal ligation apply to the subject and partner, to update trial duration and the estimated number of enrolled subjects, and to make administrative changes
    11 Apr 2014
    Amendment 3: The study duration was reduced from 52 weeks to 26 weeks and the number of assessments was decreased, as well as administrative clarifications were made
    13 Jun 2014
    Amendment 4: Include Columbia-Suicide Severity Rating Scale (C-SSRS) assessment at Week 8 and Week 20 (removed in error from amendment 3 issued on 11 Apr 2014) and updated sponsor contact details

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 18 17:05:46 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA