Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment

NCT02013609 | Completed Phase 3 Results

• 1 other identifier: 331-13-003
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 24

Brief Summary

To investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment in active adults with MDD, 18 to 35 years old, who are experiencing an inadequate selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response in a school or work environment.

Conditions

MDD

Keywords

schizophrenia; Major depressive disorder; Anxiety Symptoms; School, Work environment; Mental Disorders; Psychotic Disorders; antipsychotic

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline to Week 12 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

  The MADRS was utilized as the primary efficacy assessment of the participant's level of depression and was administered utilizing the Structured Interview Guide for the MADRS (SIGMA). Detailed instructions for administration of this structured interview was provided in the SIGMA. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60.

  Baseline and Week 12

Secondary Outcomes (19)

• Mean Change From Baseline to Week 12 in Clinical Global Impression-Severity (CGI-S) Total Score

  Baseline and Week 12

• Mean Clinical Global Impression-Improvement (CGI-I) Score at Week 12

  Weeks 1, 2, 3, 4, 5, 6, 8, 10 and 12

• Number of Participants With CGI-I Response

  Weeks 1, 2, 3, 4, 6, 8 ,10 and 12

• Percentage of Participants With MADRS Response

  Baseline and Week 12

• Percentage of Participants With MADRS Remission

  Baseline and Week 12

Study Arms (1)

Brexpiprazole

EXPERIMENTAL

Up to 3mg/day, once daily dose, tablets, orally

Drug: Brexpiprazole

Interventions

Brexpiprazole DRUG

Treatment 12 weeks) - Up to 3 mg/day, once daily dose, tablets, orally

Brexpiprazole

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Have 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 both the Mini International Neuropsychiatric Interview (M.I.N.I.) and an adequate clinical psychiatric evaluation.
• Have a treatment history of an inadequate ADT response to at least 1 ADT (but not \> 3) for the current episode.
• Have received a single, trial-approved, SSRI or SNRI at an adequate dose for ≥ 6 weeks prior to screening.
• Are 18 to 35 years old at the time of consent (inclusive, and outpatients only).
• Are (and will be) working 20 hours or more per week or a student taking 6 credit hours or more during the trial period, however minor deviations from the "part-time" concept may be acceptable on a case-by-case basis based on approval of the medical monitor.
• Have a Hamilton Depression Rating Scale (HAM-D)- 17-item Total Score ≥ 18 at screening and baseline.
• Have a Sheehan Disability Scale (SDS) 3-item mean score ≥ 5 at baseline.

You may not qualify if:

• Subjects with any of the following current Axis I DSM-IV-TR diagnoses: 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 (NOS); eating disorders (including anorexia nervosa or bulimia); obsessive compulsive disorder; panic disorder; post-traumatic stress disorder; and attention deficit hyperactivity disorder.
• Subjects with any of the following current Axis II DSM-IV-TR diagnoses: borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorders, or mental retardation.

Sponsors & Collaborators

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

Study Sites (24)

Unknown Facility

Cerritos, California, 90703, United States

Location

Unknown Facility

Costa Mesa, California, 92626, United States

Location

Unknown Facility

Garden Grove, California, 92845, United States

Location

Unknown Facility

Glendale, California, 91206, United States

Location

Unknown Facility

Orange, California, 92868, United States

Location

Unknown Facility

Riverside, California, 92506, United States

Location

Unknown Facility

San Diego, California, 92121, United States

Location

Unknown Facility

Norwich, Connecticut, 06360, United States

Location

Unknown Facility

Fort Myers, Florida, 33912, United States

Location

Unknown Facility

Hialeah, Florida, 33016, United States

Location

Unknown Facility

Melbourne, Florida, 32901, United States

Location

Unknown Facility

Orlando, Florida, 32806, United States

Location

Unknown Facility

Atlanta, Georgia, 30328, United States

Location

Unknown Facility

Prairie Village, Kansas, 66206, United States

Location

Unknown Facility

Weymouth, Massachusetts, 02190, United States

Location

Unknown Facility

Las Vegas, Nevada, 89102, United States

Location

Unknown Facility

Brooklyn, New York, 11235, United States

Location

Unknown Facility

Jamaica, New York, 11235, United States

Location

Unknown Facility

Staten Island, New York, 10312, United States

Location

Unknown Facility

Portland, Oregon, 97210, United States

Location

Unknown Facility

Austin, Texas, 78731, United States

Location

Unknown Facility

Houston, Texas, 77007, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Weiss C, Meehan SR, Brown TM, Gupta C, Morup MF, Thase ME, McIntyre RS, Ismail Z. Effects of adjunctive brexpiprazole on calmness and life engagement in major depressive disorder: post hoc analysis of patient-reported outcomes from clinical trial exit interviews. J Patient Rep Outcomes. 2021 Dec 11;5(1):128. doi: 10.1186/s41687-021-00380-4.

  PMID: 34894307 DERIVED

MeSH Terms

Conditions

Schizophrenia; Depressive Disorder, Major; Anxiety Disorders; Mental Disorders; Psychotic Disorders

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Global Medical Affairs
• Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.

800 562-3974

Study Officials

• Junichi Hashimoto, PhD

  Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 17, 2013
• Study Start: November 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 29, 2016
• Results First Posted: March 29, 2016

Record last verified: 2016-02

Locations

US (24)