Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
1 other identifier
interventional
850
1 country
50
Brief Summary
Primary: To compare the efficacy of OPC-34712 to placebo as adjunctive treatment to an assigned open-label marketed antidepressant treatment (ADT)in patients who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed ADT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 major-depressive-disorder
Started May 2009
Shorter than P25 for phase_2 major-depressive-disorder
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2008
CompletedFirst Posted
Study publicly available on registry
November 25, 2008
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
December 3, 2015
CompletedFebruary 29, 2016
February 1, 2016
1.1 years
November 24, 2008
August 7, 2015
February 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.
The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. 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. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.
Week 8 to Week 14
Secondary Outcomes (13)
Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
Week 8 to Week 14
Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (QLES-Q-SF) Subscale Score - the Overall General Subscore (Sum of First 14 Items).
Week 8 to Week 14
Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Score (the Mean of 3 Individual Item Scores).
Week 8 to Week 14
Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
Week 8 to each of Week 9, 10, 11, 12 and 13.
Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
Week 8 to each of Week 9, 10, 11, 12 and 13.
- +8 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALOPC-34712 + ADT
2
PLACEBO COMPARATORPlacebo + ADT
Interventions
Tablets, Oral, 1 - 4 mg OPC-34712 variable dose once daily, 14 weeks
Tablets, 10 - 225 mgs, dose once daily, 14 weeks
Eligibility Criteria
You may qualify if:
- Male or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by DSM-IV-TR criteria
- The current depressive episode must be equal to or greater than 8 weeks in duration
- Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than three 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
- Subjects with a clinically significant current Axis II (DSM-IV-TR)
- diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Pacific Clinical Research Medical Group
Arcadia, California, 91007, United States
Southwestern Research
Beverly Hills, California, 90210, United States
Synergy Escondido
Escondido, California, 92025, United States
Collaborative Neuroscience Network Inc.
Garden Grove, California, 92845, United States
Synergy Clinical Research Center
National City, California, 91950, United States
Excell Research
Oceanside, California, 92056, United States
Affiliated Research Institute
San Diego, California, 92108, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403, United States
Radiant Research Center
Denver, Colorado, 80239, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, 34208, United States
CNS Clinical Research Group
Coral Springs, Florida, 33065, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216, United States
Accurate Clinical Trials
Kissimee, Florida, 34741, United States
Clinical Neurosciences Solutions
Orlando, Florida, 32806, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
University of South Florida College of Medicine Psychiatry Center
Tampa, Florida, 33613, United States
Janus Center
West Palm Beach, Florida, 33407, United States
Carman Research
Smyrna, Georgia, 30080, United States
Uptown Research Institute
Chicago, Illinois, 60640, United States
Midwest Center for Neurobehavioral Medicine
Oakbrook Terrace, Illinois, 60181, United States
The Davis Clinic, PC
Indianapolis, Indiana, 46260, United States
Vince & Associates Clinical Research
Overland Park, Kansas, 66212, United States
Pharmasite Research, Inc.
Baltimore, Maryland, 21208, United States
Bioscience Research
Mount Kisco, New York, 10549, United States
Eastside Comprehensive Medical Center
New York, New York, 10021, United States
Medical & Behavioral Health Research, PC
New York, New York, 10023, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Carolinas HealthCare - Behavioral Heath Center
Charlotte, North Carolina, 28211, United States
NorthCoast Clinical Trials, Inc
Beachwood, Ohio, 44122, United States
Neuro-Behavioral Clinical Research, Inc
Canton, Ohio, 44718, United States
Patient Priority Clinical Sites, LLC
Cinncinnati, Ohio, 45242, United States
Midwest Clinical Research Center
Dayton, Ohio, 45408, United States
NorthStar Medical Research, LLC
Middleburg Heights, Ohio, 44130, United States
Summitt Research Network (Oregon)
Portland, Oregon, 97210, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
USC School of Medicine- Department of Neuropsychiatry and Behavioral Science
Columbia, South Carolina, 29203, United States
Clinical Neurosciences Solutions, Inc.
Memphis, Tennessee, 38119, United States
Community Clinical Research, Inc.
Austin, Texas, 78754, United States
FutureSearch Clinical Trials
Austin, Texas, 78756, United States
Radiant Research
Salt Lake City, Utah, 84107, United States
Mood Disorders Clinic
Salt Lake City, Utah, 84132, United States
Psychiatric Alliance of the Blue Ridge
Charlottesville, Virginia, 22903, United States
NeuroScience, Inc.
Herndon, Virginia, 20170, United States
Dominion Clinical Research
Midlothian, Virginia, 23112, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, United States
Northbrooke Research Center
Brown Deer, Wisconsin, 53223, United States
Dean Foundation
Middleton, Wisconsin, 53562, United States
Related Publications (1)
Hobart M, Zhang P, Weiss C, Meehan SR, Eriksson H. Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale. Int J Neuropsychopharmacol. 2019 Mar 1;22(3):173-179. doi: 10.1093/ijnp/pyy095.
PMID: 30508090DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Affairs
- Organization
- Otsuka Pharmaceutical Development & Commercialization, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2008
First Posted
November 25, 2008
Study Start
May 1, 2009
Primary Completion
June 1, 2010
Study Completion
July 1, 2010
Last Updated
February 29, 2016
Results First Posted
December 3, 2015
Record last verified: 2016-02