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    Clinical Trial Results:
    Interventional, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study to evaluate the efficacy and safety of brexpiprazole (1 and 3 mg/day) as adjunctive treatment in elderly patients with major depressive disorder with an inadequate response to antidepressant treatment THE STUDY WAS PREMATURELY TERMINATED AND NO FIRM CONCLUSIONS CAN BE DRAWN REGARDING SAFETY AND EFFICACY

    Summary
    EudraCT number
    2012-001361-32
    Trial protocol
    SE   LT   FI   SK   EE   BG   GB   PL   RO  
    Global end of trial date
    22 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
    14571A
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01837797
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9,, Valby, Denmark,
    Public contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, 45 36301 311, LundbeckClinicalTrials@lundbeck.com
    Scientific contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, 45 36301 311, 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
    22 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    22 May 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Efficacy on depressive symptoms of brexpiprazole versus placebo as adjunctive treatment to antidepressants in elderly patients with an inadequate response to antidepressant treatment
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2008) and ICH Good Clinical Practice (1996)
    Background therapy
    standard antidepressant treatment, specifically; escitalopram, fluoxetine, sertraline, paroxetine IR, venlafaxine XR, duloxetine
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Apr 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    1 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    Romania: 2
    Country: Number of subjects enrolled
    Slovakia: 4
    Country: Number of subjects enrolled
    Sweden: 10
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Bulgaria: 1
    Country: Number of subjects enrolled
    Estonia: 3
    Country: Number of subjects enrolled
    Finland: 3
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Lithuania: 3
    Country: Number of subjects enrolled
    United States: 67
    Country: Number of subjects enrolled
    Ukraine: 4
    Country: Number of subjects enrolled
    Russian Federation: 10
    Worldwide total number of subjects
    129
    EEA total number of subjects
    48
    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)
    0
    From 65 to 84 years
    129
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients were recruited from the investigator's own patient population, via advertisement (if allowed in the country), via general pratitioners or or referrals

    Pre-assignment
    Screening details
    The study consisted of a screening period (could last from 3 to 28 days)

    Period 1
    Period 1 title
    Periode 1
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Arm title
    antidepressants treatment with double-blind study treatment
    Arm description
    The patients received open-label treatment with one of six commercially available antidepressant antidepressant treatments (ADT) together with double-blind study treatment
    Arm type
    Non-investigational Medicinal Products

    Investigational medicinal product name
    Duloxetine (Cymbalta)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg/day, capsules, orally

    Investigational medicinal product name
    Escitalopram (Cipralex or Lexapro)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 or 10 mg/day, tablets, orally

    Investigational medicinal product name
    Fluoxetine (Prozac)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    20 or 40 mg/day, capsules, orally

    Investigational medicinal product name
    Paroxetine (Paxil or Seroxat)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20, 30 or 40mg/day, orally, tablets

    Investigational medicinal product name
    Sertraline (Lustral or Zoloft)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50, 100 or 150 mg/day

    Investigational medicinal product name
    Venlafaxine (Effexor XL or Effexor XR)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    75, 150 or 225 mg/day, capsules, orally

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily, tablets, orally for 8 or 10 weeks

    Number of subjects in period 1
    antidepressants treatment with double-blind study treatment
    Started
    129
    Completed
    27
    Not completed
    102
         Consent withdrawn by subject
    6
         Withdrew consent before ADT
    1
         Adverse event, non-fatal
    9
         Administrative or other
    76
         Other
    10
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Brexpiprazole 1 mg and ADT
    Arm description
    Brexpiprazole adjunct to continued open-label treatment with a commercially available ADT received in Period 1
    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
    1 mg once daily, tablets, orally

    Arm title
    Brexpiprazole 3 mg and ADT
    Arm description
    Brexpiprazole adjunct to continued open-label treatment with a commercially available ADT received in Period 1
    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
    3 mg once daily, tablets, orally

    Arm title
    Placebo and ADT
    Arm description
    Placebo adjunct to continued open-label treatment with a commercially available ADT
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily, tablets, orally

    Number of subjects in period 2 [1]
    Brexpiprazole 1 mg and ADT Brexpiprazole 3 mg and ADT Placebo and ADT
    Started
    3
    6
    6
    Completed
    1
    1
    1
    Not completed
    2
    5
    5
         Adverse event, non-fatal
    -
    1
    -
         The study was prematurely terminated
    2
    4
    5
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only patients with prospectively assessed inadequate response were randomised to Period 2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Periode 1
    Reporting group description
    -

    Reporting group values
    Periode 1 Total
    Number of subjects
    129 129
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    0 0
        From 65-84 years
    129 129
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    70 ( 4.75 ) -
    Gender categorical
    Units: Subjects
        Female
    99 99
        Male
    30 30

    End points

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    End points reporting groups
    Reporting group title
    antidepressants treatment with double-blind study treatment
    Reporting group description
    The patients received open-label treatment with one of six commercially available antidepressant antidepressant treatments (ADT) together with double-blind study treatment
    Reporting group title
    Brexpiprazole 1 mg and ADT
    Reporting group description
    Brexpiprazole adjunct to continued open-label treatment with a commercially available ADT received in Period 1

    Reporting group title
    Brexpiprazole 3 mg and ADT
    Reporting group description
    Brexpiprazole adjunct to continued open-label treatment with a commercially available ADT received in Period 1

    Reporting group title
    Placebo and ADT
    Reporting group description
    Placebo adjunct to continued open-label treatment with a commercially available ADT

    Primary: Number of treatment-emergent adverse events

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    End point title
    Number of treatment-emergent adverse events [1]
    End point description
    The primary endpoint was efficacy, however the study was prematurely terminated and the limited number of enrolled patients resulted in insufficient data for meaningful analyses. Therefore treatment-emergent adverse events are disclosed
    End point type
    Primary
    End point timeframe
    First dose to follow-up (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
    End point values
    Brexpiprazole 1 mg and ADT Brexpiprazole 3 mg and ADT Placebo and ADT
    Number of subjects analysed
    3
    6
    6
    Units: Number
    5
    2
    3
    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
    Placebo + ADT
    Reporting group description
    Placebo + ADT

    Reporting group title
    Brex 3 mg + ADT
    Reporting group description
    Brex 3 mg + ADT

    Reporting group title
    Brex 1 mg + ADT
    Reporting group description
    Brex 1 mg + ADT

    Serious adverse events
    Placebo + ADT Brex 3 mg + ADT Brex 1 mg + ADT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo + ADT Brex 3 mg + ADT Brex 1 mg + ADT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 6 (33.33%)
    2 / 6 (33.33%)
    2 / 3 (66.67%)
    Investigations
    Weight increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Accidental overdose
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Dizziness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Parkinson's disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    Tremor
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Gait disturbance
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    Dyspnoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Bruxism
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    Insomnia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 May 2013
    The main reason for the amendment was to correct errors and clarify the current protocol text in various sections of the protocol

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Apr 2014
    The study was prematurely terminated because of recruitment challenges
    -

    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
    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.

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