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

MDD Clinical Trial

Official title:

Protocol 331-13-003: An Exploratory, Multicenter, Open-label, Flexible-dose Trial of 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02013609
• Other study ID #: 331-13-003
• Status: Completed
• Phase: Phase 3
• First received: December 6, 2013
• Last updated: November 6, 2014
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Main Inclusion Criteria:

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.

Main Exclusion Criteria:

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• MDD

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MADRS Total Score change from baseline to Week 12		Week 12	No
Secondary	CGI-S score change from baseline to Week 12		Weeks 12	No
Secondary	CGI-I score at Week 12		Week 12	No
Secondary	MADRS response rate, where response is defined as = 50% reduction in respective total scores from baseline to Week 12.		Week 12	No
Secondary	MADRS remission rate, where remission is defined as MADRS Total Score = 10 and 50% reduction in MADRS Total Score from baseline to Week 12.		Week 12	No
Secondary	HAM-D-17 Total Score change from baseline to Week 12		Week 12	No
Secondary	SDS 3-item mean score change from baseline to Week 12		Week 12	No
Secondary	SDS single-item subscores change from baseline to Week 12		Week 12	No
Secondary	SASS Total Score change from baseline to Week 12		Week 12	No
Secondary	MGH-CPFQ Total Score change from baseline to Week 12		Week 12	No
Secondary	KSQ change from baseline to Week 12		Week 12	No
Secondary	Go/No-Go task change from baseline to Week 12		Week 12	No
Secondary	Delay Discounting task - MCQ scores change from baseline to Week 12		Week 12	No
Secondary	Delay Discounting task - EDT scores change from baseline to Week 12		Week 12	No
Secondary	BIS-11 change from baseline to Week 12		Week 12	No