Trial document




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  DRKS00007103

Trial Description

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Title

A Phase 3, Multicenter, Randomized, Double-blind,
Placebo-controlled Trial of the Safety and Efficacy of
Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive
Therapy in the Treatment of Adults with Major Depressive Disorder With and Without Anxious Distress

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to evaluate the safety and effectiveness of an investigational antipsychotic drug called brexpiprazole compared to placebo (an inactive substance) in subjects with MDD when taken at the same time as a marketed antidepressant therapy. About 900 subjects will participate in this study at approximately 50 sites worldwide. Your participation in this study will last approximately 15-22 weeks (including the screening and follow-up period) and will include up to 15 study visits to the study site.

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Brief Summary in Scientific Language

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled, fixed-dose trial designed to assess the safety and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy to an assigned open-label ADT in depressed subjects with and without anxious distress who have demonstrated an
inadequate response to prospective treatment with the same ADT. The trial will be organized as follows:
Screening Phase: The screening period will range from a minimum of 7 days to a maximum of 28 days and will begin when informed consent is signed. The purpose of the screening period is to assess eligibility criteria at 1 or more visits (as necessary to complete screening assessments) and to washout prohibited concomitant harmacotherapy, if applicable. An interactive web response system (IWRS) will be used to obtain the subject identification for each subject
with a signed informed consent form (ICF). If applicable, subjects will washout from their current ADT for a minimum of 24 hours before receiving the first dose of investigatorassigned
ADT in Phase A. In instances where a subject will be assigned to the same ADT, the 24-hour washout period is not necessary (ie, a prior course of treatment with 1 of the protocol-specified ADTs that was at an adequate dose per the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire [ATRQ], but of insufficient duration).

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Organizational Data

  •   DRKS00007103
  •   2014/10/29
  •   2014/10/29
  •   no
  •   Approved
  •   25/2014, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

  •   2014-000062-22 
  •   NCT02196506  (ClinicalTrials.gov)
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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
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Interventions/Observational Groups

  •   Brexpiprazol 2.0 mg/day and Standard Antidepressiva
  •   Plazebo and Standard Antidepressia
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   No
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Primary Outcome

To compare the efficacy of brexpiprazole (2.0 mg/day) to placebo as adjunctive therapy to an assigned open-label antidepressant therapy (ADT) in subjects who demonstrate an inadequate response to a prospective 8-week
trial of the same assigned open-label ADT.

The primary outcome variable for determination of efficacy is the change from Week 8 visit to Week 14 visit in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

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Secondary Outcome

To evaluate the safety and tolerability of brexpiprazole (2.0 mg/day) as adjunctive therapy to ADT in the proposed
subject population with MDD.

The key secondary efficacy variables are as follows:
- change from Week 8 visit to end of
Week 14 visit in SDS Mean Score (the mean of
3 individual item scores) for the Efficacy Sample;
- change in MADRS Total Score for the
subpopulation with <25% improvement from baseline to week 8
- change from Week 8 visit to Week 14 visit in MADRS Total Score for the
subpopulations with and without anxious distress

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Countries of Recruitment

  •   Germany
  •   Hungary
  •   Poland
  •   Slovakia
  •   United States
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Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2014/11/14
  •   900
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

Subjects with both a diagnosis of MDD, and in a current major depressive episode, as defined by
DSM-IV-TR criteria and confirmed by both the Mini International Neuropsychiatric Interview and an
adequate clinical psychiatric evaluation. The current
major depressive episode must be _> 8 weeks in duration. In addition, subjects must have reported a history for the current major depressive episode of an
inadequate response to at least 1 and no more than 3 adequate antidepressant treatments. An inadequate response is defined as < 50% reduction in depressive
symptom severity, as assessed by the ATRQ.
Adequate treatment is defined as an antidepressant
treatment for at least 6 weeks in duration at a minimum
dose (or higher) as specified in the ATRQ. If the
subject showed _> 50% improvement on any
antidepressant treatment in the current episode, then the
subject must have had an inadequate response to a
subsequent adequate antidepressant treatment (as
defined above by the ATRQ) of another antidepressant
drug prior to entry into the trial. For the most recent
antidepressant treatment, the subject must not report
_>50% improvement (as defined above by the ATRQ).
_> Subjects with a HAM-D17 Total Score _> 18 at the
screening and baseline visits.

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Exclusion Criteria

Subjects who report an inadequate response (less than 50% reduction in depressive symptom severity) to more than 3 monotherapy antidepressant treatments during the current major depressive episode at a therapeutic dose (as defined by the ATRQ) and for an adequate duration (minimum duration of 6 weeks), including any antidepressant that the subject may be taking at screening if it meets the criteria for adequate treatment.

- Subjects with a current Axis I (DSM-IV-TR) diagnosis of:

- Delirium, dementia, amnestic or other cognitive disorder
- Schizophrenia, schizoaffective disorder, or other psychotic disorder
- Bipolar I or II disorder, or bipolar disorder not otherwise specified
- Eating disorder (including anorexia nervosa or bulimia)
- Obsessive compulsive disorder
- Panic disorder
- Post-traumatic stress disorder

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Addresses

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    • Otsuka Pharmaceutical Development & Commercialization, Inc.
    • Mr.  Aleksandar  Skuban 
    • 2440 Research Boulevard
    • 20850  Rockville
    • United States
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    • INC Research UK Ltd
    • Alistair  MacDonald 
    • River View, The Meadows Business Park, Station Approach
    • GU179AB  Camberley
    • United Kingdom
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    • INC Research GmbH
    • Ms.  Carmen  Masanneck 
    • Katzbergstr. 3
    • 40764  Langenfeld
    • Germany
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Sources of Monetary or Material Support

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    • Otsuka Pharmaceutical Development & Commercialization
    • Aleksandar  Skuban 
    • 2440 Research Boulevard
    • 20850  Rockville, Maryland
    • United States
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.