Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms

Anxiety Clinical Trial

Official title:

Protocol 331-13-002: An Exploratory, Multicenter, Open-label, Flexible-dose Trial of Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02013531
• Other study ID #: 331-13-002
• Status: Completed
• Phase: Phase 3
• First received: December 6, 2013
• Last updated: April 30, 2015
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• 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

The purpose of this study is to investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment in subjects with major depressive disorder and anxiety symptoms, who are experiencing an inadequate selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 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 65 years old at the time of consent (inclusive, and outpatients only).

• Have a Hamilton Depression Rating Scale (HAM-D)-17-item Total Score = 18 at screening and baseline.

• Have a Hamilton Anxiety Rating Scale (HAM-A) Total Score = 20 at screening and baseline.

Main Exclusion Criteria:

Subjects with any of the following current Axis I DSM-IV-TR diagnoses:

• delirium

• dementia

• amnestic

• other cognitive disorders

• schizophrenia

• schizoaffective disorder

• other psychotic disorders

• bipolar I disorder,

• bipolar II disorder

• bipolar disorder not otherwise specified (NOS)

• eating disorders

• anorexia nervosa

• bulimia

• obsessive compulsive disorder

• post-traumatic stress disorder

Subjects with any of the following current Axis II DSM-IV-TR diagnoses:

• borderline, antisocial

• paranoid

• schizoid

• schizotypal

• histrionic personality disorders

• mental retardation.

Study Design

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Brexpiprazole
Treatment (6 weeks) - Up to 3mg/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 6		Week 6	No
Secondary	CGI-S score change from baseline to Week 6		Week 6	No
Secondary	CGI-I score at Week 6.		Week 6	No
Secondary	MADRS response rate, where response is defined as = 50% reduction in respective total scores from baseline to Week 6		Week 6	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 6.		Week 6	No
Secondary	HAM-D-17 Total Score change from baseline to Week 6		Week 6	No
Secondary	HAM-A Total Score change from baseline to Week 6		Week 6	No
Secondary	SDS 3-item mean score change from baseline to Week 6		Week 6	No
Secondary	MGH-CPFQ Total Score change from baseline to Week 6		Week 6	No
Secondary	KSQ change from baseline to Week 6		Week 6	No
Secondary	Go/No-Go task change from baseline to Week 6		Week 6	No
Secondary	Delay Discounting task-MCQ scores change from baseline to Week 6		Week 6	No
Secondary	Delay Discounting task-EDT scores change from baseline to Week 6		Week 6	No
Secondary	BIS-11 change from baseline to Week 6		Week 6	No