Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder

Study Identifier:
331-201-00289
ClinicalTrials.gov Identifier:
NCT04830215
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
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Results Availables

Study Protocol
Available Language: English
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Statistical Analysis Plan
Available Language: English
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Study Details

Medical Condition
  • Depression
Study Drug
  • Drug: Brexpiprazole
Date
Apr 2021 - May 2022
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Male and female participants (outpatients) between the regional age of majority (18 or 19 years of age) to 65 years of age, inclusive, at the time of informed consent.
  • Primary diagnosis of MDD and in a current non-psychotic major depressive episode (MDE) as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, who have been outpatients for at least 4 weeks, and have an inadequate response, per investigator judgment, to 1 or 2 adequate treatments of ADTs in their current MDE, including current ADT.
  • Participants with a Patient Health Questionnaire 9-item scale (PHQ-9) ≥ 15 at the screening and baseline visits, if separate.
Exclusion Criteria
  • Participants currently or previously treated with brexpiprazole including participants who received brexpiprazole in any prior clinical trial.
  • Participants with a concurrent DSM-5 diagnosis of the following will be excluded:
  • Schizophrenia or schizoaffective disorder
  • Bipolar I or bipolar II disorder
  • Post-traumatic stress disorder
  • Dementia
  • Eating disorder
  • Borderline personality disorder
  • Antisocial personality disorder
  • Participants with a suicidality score of 3 based on Inventory of Depressive Symptomatology Self-Report (IDS-SR) suicidality item 18 or participants who, in the opinion of the investigator, presents a serious risk of suicide.

Protocol Summary

The clinical trial will investigate the effect of brexpiprazole on the concept of life engagement in participants with Major Depressive Disorder (MDD) with a current depressive episode.

Study Locations

Location
Status
Location
Chatham-Kent Clinical Trials Research Centre
Chatham, Ontario, Canada, N7L 1C1
Status
N/A
© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • Male and female participants (outpatients) between the regional age of majority (18 or 19 years of age) to 65 years of age, inclusive, at the time of informed consent.
  • Primary diagnosis of MDD and in a current non-psychotic major depressive episode (MDE) as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, who have been outpatients for at least 4 weeks, and have an inadequate response, per investigator judgment, to 1 or 2 adequate treatments of ADTs in their current MDE, including current ADT.
  • Participants with a Patient Health Questionnaire 9-item scale (PHQ-9) ≥ 15 at the screening and baseline visits, if separate.
Exclusion criteria
  • Participants currently or previously treated with brexpiprazole including participants who received brexpiprazole in any prior clinical trial.
  • Participants with a concurrent DSM-5 diagnosis of the following will be excluded:
  • Schizophrenia or schizoaffective disorder
  • Bipolar I or bipolar II disorder
  • Post-traumatic stress disorder
  • Dementia
  • Eating disorder
  • Borderline personality disorder
  • Antisocial personality disorder
  • Participants with a suicidality score of 3 based on Inventory of Depressive Symptomatology Self-Report (IDS-SR) suicidality item 18 or participants who, in the opinion of the investigator, presents a serious risk of suicide.

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