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    Clinical Trial Results:
    Interventional, open-label, long-term extension study to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in patients with major depressive disorder. THE STUDY WAS PREMATURELY TERMINATED AND NO FIRM CONCLUSIONS CAN BE DRAWN REGARDING SAFETY AND EFFICACY

    Summary
    EudraCT number
    		 2012-004169-42
    Trial protocol
    		 SE   LT   DE   GB   IT   FI   SK   PL   BG   LV   EE  
    Global end of trial date
    13 May 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jul 2016
    First version publication date
    22 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    000014767B
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01944969
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9, Valby, Denmark, 2500
    Public contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@lundbeck.com
    Scientific contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@lundbeck.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
    13 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    13 May 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety and tolerability of brexpiprazole as adjunct treatment to antidepressant (ADT)
    Protection of trial subjects
    Safety data were reviewed regularly by the Lundbeck brexpiprazole Safety Committee to ensure that prompt action was taken, if needed, to maximise patient safety.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Oct 2013
    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
    Slovakia: 2
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Estonia: 3
    Country: Number of subjects enrolled
    Finland: 2
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    United States: 14
    Worldwide total number of subjects
    26
    EEA total number of subjects
    12
    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)
    3
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients who had completed a randomised, double-blind study with adjunctive brexpiprazole treatment of MDD (lead-in studies 14570A or 14571A) were eligible to enter this extension study.

    Pre-assignment
    Screening details
    		 Patients who had completed a randomised, double-blind study with adjunctive brexpiprazole treatment of MDD (lead-in studies 14570A or 14571A) were eligible to enter this extension study.

    Period 1
    Period 1 title
    Baseline (week 0-4)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adult (lead in from study 14570A)
    Arm description
    		 Baseline visit in this study was the same as completion visit in the lead in study 14570A (adults).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brexpiprazole
    Investigational medicinal product code
    Lu AF41156
    Other name
    OPC-34712
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The patients received brexpiprazole 1 mg/day for the first week, and during the next 3 weeks were up-titrated in weekly steps to maximally 3 mg/day. In addition they received the same ADT as used in the lead in study.

    Arm title
    		 Elderly (lead in from study 14571A)
    Arm description
    		 Baseline visit was the same as the completion visit in the lead in study 14571A (elderly).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brexpiprazole
    Investigational medicinal product code
    Lu AF41156
    Other name
    OPC-34712
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The patients received brexpiprazole 0.5 mg/day for the first week, and during the next 3 weeks were up-titrated in weekly steps to maximally 3 mg/day. In addition they received the same ADT as used in the lead in study.

    Number of subjects in period 1
    		Adult (lead in from study 14570A) Elderly (lead in from study 14571A)
    Started
    3
    23
    Completed
    3
    23
    Period 2
    Period 2 title
    Mainteance treatment (week 4 onwards)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Total
    Arm description
    		 Up to 3 mg brexpiprazole per day plus continuation of adjunctive treatment to antidepressant treatment (ADT) received in lead in study
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brexpiprazole
    Investigational medicinal product code
    Lu AF41156
    Other name
    OPC-34712
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The dose of brexpiprazole could be increased or decreased during the study within the range of 1 to 3 mg/day. The dose of ADT should remain stable as much as possible, but could be changed from Week 14 onwards, if considered necessary by the investigator. Treatment with brexpiprazole was to be continued up to 52 weeks. However, the study was prematirely terminated. 

    Number of subjects in period 2
    		Total
    Started
    26
    Completed
    0
    Not completed
    26
         Adverse event, non-fatal
    1
         Non-compliance with IMP
    1
         Early termination of the study
    23
         Lack of efficacy
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adult (lead in from study 14570A)
    Reporting group description
    		 Baseline visit in this study was the same as completion visit in the lead in study 14570A (adults).

    Reporting group title
    Elderly (lead in from study 14571A)
    Reporting group description
    		 Baseline visit was the same as the completion visit in the lead in study 14571A (elderly).

    Reporting group values
    		 Adult (lead in from study 14570A) Elderly (lead in from study 14571A) Total
    Number of subjects
    		 3 23 26
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 3 0 3
        From 65-84 years
    		 0 23 23
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44 ( 16.52 ) 69 ( 3.74 ) -
    Gender categorical
    Units: Subjects
        Female
    		 3 18 21
        Male
    		 0 5 5

    End points

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    End points reporting groups
    Reporting group title
    Adult (lead in from study 14570A)
    Reporting group description
    		 Baseline visit in this study was the same as completion visit in the lead in study 14570A (adults).

    Reporting group title
    Elderly (lead in from study 14571A)
    Reporting group description
    		 Baseline visit was the same as the completion visit in the lead in study 14571A (elderly).
    Reporting group title
    Total
    Reporting group description
    		 Up to 3 mg brexpiprazole per day plus continuation of adjunctive treatment to antidepressant treatment (ADT) received in lead in study

    Primary: Total number of treatment-emergent adverse events

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    End point title
    		 Total number of treatment-emergent adverse events [1]
    End point description
    Please see Adverse events section for full adverse event report
    End point type
    Primary
    End point timeframe
    baseline to end of study (prematurely terminated)
    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 comparison between parameters were performed. Only number of adverse event are reported
    End point values
    		 Total Adult (lead in from study 14570A) Elderly (lead in from study 14571A)
    Number of subjects analysed
    26
    3
    23
    Units: number
    28
    2
    26
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose to follow-up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Total
    Reporting group description
    		 -

    Serious adverse events
    		 Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 26 (19.23%)
    Injury, poisoning and procedural complications
    Accidental overdose
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 26 (11.54%)
         occurrences all number
    3
    Nervous system disorders
    Lethargy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 26 (7.69%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Apr 2014
    Early termination
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Early termination leading to a small number analysed; only AEs reported
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    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.

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