Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder

NCT01447576 | Completed Phase 2 Results DMC

• 1 other identifier: 331-08-212
• Study Type: interventional
• Target: 1,036
• Locations: 1 country
• Sites: 32

Brief Summary

The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive Disorder (MDD).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Participants With Adverse Events (AEs).

  An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the physician. The severity was assessed as mild, moderate, or severe. A treament-emergent AE (TEAE) was defined as any AE that started after start of open-label brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study drug.

  After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visit

Secondary Outcomes (2)

• Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.

  Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (last-observation-carried-forward [LOCF])

• Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.

  Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF)

Study Arms (1)

OPC-34712 + ADT

EXPERIMENTAL

Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Antidepressant drug treatment

Drug: ADT; Drug: OPC-34712

Interventions

ADT DRUG

Once daily dosing during the duration of the study.

Also known as: Anti-depressant Drug Therapy

OPC-34712 + ADT

OPC-34712 DRUG

OPC-34712, Oral Tablets, 0.25 - 3 mg

OPC-34712 + ADT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects between 18 and 65 years of age, with a diagnosis of a single or recurrent, non-psychotic episode of major depressive disorder, as defined by DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) which is equal to or greater than 8 weeks in duration.
• Subjects must currently be taking allowable antidepressant therapy at an adequate dose for a minimum of six weeks by the end of the screening period (ie at the time of the Baseline visit).
• Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than four adequate antidepressant treatments.

You may not qualify if:

• Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug.
• Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration.
• Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia,amnestic or other cognitive disorder Schizophrenia, schizoaffective disorder, or other psychotic disorder Bipolar I or II disorder, eating disorder (including anorexia nervosa or bulimia), obsessive compulsive disorder, panic disorder, post-traumatic stress disorder.
• Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (32)

Pacific Clinical Research Medical Group

Arcadia, California, 91007, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92123, United States

Location

California Neuroscience Research Medical Group, Inc.

Sherman Oaks, California, 91403, United States

Location

Gulfcoast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

Clinical Neuroscience Solutions

Jacksonville, Florida, 32216, United States

Location

Florida Clinical Research Center

Maitland, Florida, 32751, United States

Location

Clinical Neurosciences Solutions

Orlando, Florida, 32806, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Carman Research

Smyrna, Georgia, 30080, United States

Location

Goldpoint Clinical Research, LLC

Indianapolis, Indiana, 46240, United States

Location

Pharmasite Research

Baltimore, Maryland, 91208, United States

Location

Clinical Insights

Glen Burnie, Maryland, 21061, United States

Location

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Brooklyn Medical Institute

Brooklyn, New York, 11214, United States

Location

Medical & Behavioral Health Research

New York, New York, 10023, United States

Location

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Oregon Center for Clinical Investigations, Inc.

Portland, Oregon, 97210, United States

Location

Oregon Center for Clinical Investigations

Salem, Oregon, 97301, United States

Location

Carolina Clinical Research Services

Columbia, South Carolina, 29201, United States

Location

FutureSearch Trials of Dallas

Dallas, Texas, 75231, United States

Location

Bayou City Research, Ltd.

Houston, Texas, 77007, United States

Location

Radiant Research

Murray, Utah, 84123, United States

Location

Psychiatric Alliance of the Blue Ridge

Charlottesville, Virginia, 22903, United States

Location

Neuroscience, Inc.

Herndon, Virginia, 20170, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Summit Research Network

Seattle, Washington, 98104, United States

Location

Northbrooke Research Center

Brown Deer, Wisconsin, 53223, United States

Location

Dean Foundation

Middleton, Wisconsin, 53562, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

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

800 562-3974

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: October 6, 2011
• Study Start: September 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 6, 2015
• Results First Posted: November 6, 2015

Record last verified: 2015-10

Locations

US (32)