Brexpiprazole (OPC 34712) Trial in the Treatment of Adults With Major Depressive Disorder and Irritability

NCT02212613 | Withdrawn Phase 3

• 1 other identifier: 331-13-004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the effects of fixed-dosed brexpiprazole adjunctive treatment in subjects with Major Depressive Disorder with irritability

Conditions

Major Depressive Disorder and Irritability

Keywords

Major Depressive Disorder; Mental Disorders, nonpsychotic episode, antipsychotic; Mood Disorder, psychotic disorder

Outcome Measures

Primary Outcomes (1)

• Change from Phase B baseline to Phase B Week 6 in functional magnetic resonance imaging (fMRI) BOLD activation score in the ventromedial prefrontal cortex and amygdala, scanned by fMRI during performance of the Emotion-induction Task

  Week 6

Secondary Outcomes (12)

• Change from Phase B baseline to Phase B Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score

  Week 6

• Change from Phase B baseline to Phase B Week 6 in Spielberger State Trait Anger Expression Inventory (STAXI-2) Part 1

  Week 6

• Change from Phase B baseline to Phase B Week 6 in Visual Analog Scale (VAS)

  Week 6

• Change from Phase B baseline to Phase B Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) score

  Week 6

• Clinical Global Impression - Improvement Scale (CGI-I) score at Phase B Week 6

  Week 6

Study Arms (1)

Brexpiprazole

EXPERIMENTAL

Brexpiprazole - Up to 2 mg/day, once daily dose, tablets, orally

Drug: Brexpiprazole

Interventions

Brexpiprazole DRUG

Treatment (6 weeks) Up to 2 mg/day, once daily dose, tablets, orally

Also known as: OPC-34712

Brexpiprazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Are 18 to 55 years of age, inclusive, at the time of informed consent with a diagnosis of a single or recurrent, nonpsychotic episode of MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR™) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) and an adequate clinical psychiatric evaluation
• Have received a single, trial-approved SSRI or SNRI at an adequate dose for ≥ 6 weeks prior to screening
• Have a treatment history of inadequate ADT response to at least one ADT (but not \> 3) for the current episode. The current major depressive episode must be ≥ 6 weeks in duration. (An inadequate ADT response is defined as \< 50% reduction in depressive symptom severity, as measured by subject self-report on the MGH-ATRQ.)
• To be eligible for this trial
• Have a MADRS Total Score of 20 or more at screening and the Phase A baseline, and have a MADRS Total Score of 18 or more at the Phase B baseline
• Have no more than 20% improvement in MADRS Total Score at Phase B baseline compared to Phase A baseline
• Have a score of 6 or more on the KSQ based on the Well being and Reversal Distress Anger-hostility subscales at screening, Phase A baseline, and Phase B baseline
• Have anger attacks as documented by the AAQ at screening, Phase A baseline, and Phase B baseline
• Are right-handed (defined according to the Edinburgh Handedness Inventory) and have normal hearing and normal/corrected-to-normal vision
• Are willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period
• Eligibility confirmed through a telephone SAFER interview with the subject and an independent expert centralized rater

You may not qualify if:

• Have a current need for involuntary commitment or have been hospitalized within 4 weeks of screening for the current major depressive episode
• Have a current DSM-IV-TR Axis I diagnosis of any of the following: delirium, dementia, amnestic, or other cognitive disorders; schizophrenia, schizoaffective disorder, or other psychotic disorders; bipolar I disorder, bipolar II disorder, or bipolar disorder not otherwise specified; eating disorders (including anorexia nervosa or bulimia); obsessive compulsive disorder; panic disorder; or post-traumatic stress disorder
• Have any of the following current Axis II DSM-IV-TR diagnoses: borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorders, or mental retardation
• Experiencing hallucinations, delusions, or any psychotic symptomatology in the current major depressive episode

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Mental Disorders; Affective Disorders, Psychotic

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Junichi Hashimoto, PhD

  Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: August 8, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 7, 2016

Record last verified: 2016-07

Locations

US (1)