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

NCT ID: NCT02212613

Last Updated: 2016-07-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Brexpiprazole

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

Group Type: EXPERIMENTAL

Brexpiprazole

Intervention Type: DRUG

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

Interventions

Brexpiprazole

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

Intervention Type: DRUG

Other Intervention Names

OPC-34712

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junichi Hashimoto, PhD

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

331-13-004

Identifier Type: -

Identifier Source: org_study_id