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

A Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adult Patients With Major Depressive Disorder

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).

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: ADT; Drug: OPC-34712

• Study Type: Interventional
• Enrollment (Actual): 1036
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Arcadia, California, United States, 91007
      • Pacific Clinical Research Medical Group
    • San Diego, California, United States, 92123
      • Artemis Institute for Clinical Research
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research Medical Group, Inc.
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Gulfcoast Clinical Research Center
    • Jacksonville, Florida, United States, 32216
      • Clinical Neuroscience Solutions
    • Maitland, Florida, United States, 32751
      • Florida Clinical Research Center
    • Orlando, Florida, United States, 32806
      • Clinical Neurosciences Solutions
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
  • Georgia
    • Smyrna, Georgia, United States, 30080
      • Carman Research
  • Indiana
    • Indianapolis, Indiana, United States, 46240
      • Goldpoint Clinical Research, LLC
  • Maryland
    • Baltimore, Maryland, United States, 91208
      • PharmaSite Research
    • Glen Burnie, Maryland, United States, 21061
      • Clinical Insights
  • Michigan
    • Rochester Hills, Michigan, United States, 48307
      • Rochester Center for Behavioral Medicine
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Center for Psychiatry and Behavioral Medicine, Inc.
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Center for Emotional Fitness
  • New York
    • Brooklyn, New York, United States, 11214
      • Brooklyn Medical Institute
    • New York, New York, United States, 10128
      • The Medical Research Network, LLC
    • New York, New York, United States, 10023
      • Medical & Behavioral Health Research
    • Rochester, New York, United States, 14618
      • Finger Lakes Clinical Research
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Center for Clinical Investigations, Inc.
    • Salem, Oregon, United States, 97301
      • Oregon Center for Clinical Investigations
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Carolina Clinical Research Services
  • Texas
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas
    • Houston, Texas, United States, 77007
      • Bayou City Research, Ltd.
  • Utah
    • Murray, Utah, United States, 84123
      • Radiant Research
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Psychiatric Alliance Of The Blue Ridge
    • Herndon, Virginia, United States, 20170
      • Neuroscience, Inc.
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Seattle, Washington, United States, 98104
      • Summit Research Network
  • Wisconsin
    • Brown Deer, Wisconsin, United States, 53223
      • Northbrooke Research Center
    • Middleton, Wisconsin, United States, 53562
      • Dean Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OPC-34712 + ADT; Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Antidepressant drug treatment	Drug: ADT; Once daily dosing during the duration of the study.; Other Names: Anti-depressant Drug Therapy; Drug: OPC-34712; OPC-34712, Oral Tablets, 0.25 - 3 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.	The CGI-S is a 7-point scale from 1 through 7. The items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill participants. The score 0 (= not assessed) was set to missing.	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.	The items on CGI-I scale are 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) was set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI improvement was compared to the participants condition at Baseline.	Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF)

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 29, 2011
• First Submitted That Met QC Criteria: October 4, 2011
• First Posted (Estimate): October 6, 2011

Study Record Updates

• Last Update Posted (Estimate): November 6, 2015
• Last Update Submitted That Met QC Criteria: October 6, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Psychotropic Drugs; Antidepressive Agents
• Other Study ID Numbers: 331-08-212