Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder
STEP-D222
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPDC-34712 (1 to 3 mg/Day) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder.
1 other identifier
interventional
773
1 country
43
Brief Summary
This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive substance) in addition to an FDA approved antidepressant in order to determine if the study medication is effective as an add on treatment of MDD.
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 Mar 2010
43 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
January 15, 2010
CompletedFirst Posted
Study publicly available on registry
January 20, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
November 2, 2015
CompletedNovember 2, 2015
September 1, 2015
1.6 years
January 15, 2010
August 4, 2015
September 30, 2015
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 the Montgomery Asberg Depression Rating Scale (MADRS) Total Score.
The MADRS was utilized as the primary efficacy assessment of a participants level of depression. The MADRS consisted 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; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were 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 of to the first decimal place.
Baseline (end of week 8) to Week 14
Secondary Outcomes (9)
Change From End of Phase A (Week 8) to Phase B in Sheehan Disability Scale (SDS) Score.
Baseline (end of week 8) to Week 14
Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Trial Week Visit in Phase B.
Baseline (end of week 8) to Week 14
Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical Global Impression- Severity Illness Scale (CGI-S) Score.
Baseline (end of week 8) to Week 14
Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.
Baseline (end of week 8) to Week 14
Change From End of Phase A (Week 8) to End of Phase B (Week 14) in the Hamilton Depression Rating Scale 17-item Version (HAM-D17) Total Score.
Baseline (end of week 8) to Week 14
- +4 more secondary outcomes
Study Arms (2)
Brexipiprazole + ADT
EXPERIMENTALOPC-34712 Tablets, Oral, 1 - 3 mg OPC-34712 + ADT
Placebo + ADT
PLACEBO COMPARATORPlacebo + ADT
Interventions
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 (43)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Pacific Clinical Research Medical Group
Arcadia, California, 91007, United States
Southwestern Research
Beverly Hills, California, 90210, United States
Excell Research
Oceanside, California, 92056, United States
Affiliated Research Institute
San Diego, California, 92108, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, 92782, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403, United States
CNS Clinical Research Group
Coral Springs, Florida, 33067, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216, United States
Scientific Clinical Research, Inc.
North Miami, Florida, 33161, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Comprehensive NeuroScience, Inc.
Atlanta, Georgia, 30328, United States
Carman Research
Smyrna, Georgia, 30080, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, 46260, United States
Vince and Associates Clinical Research
Overland Park, Kansas, 66212, United States
Clinical InSights
Glen Burnie, Maryland, 21061, United States
Pharmasite Research, Inc.
Pikesville, Maryland, 21208, United States
MSU/Institute for Health Studies
East Lansing, Michigan, 48824, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11515, 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
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Northcoast Clinical Trials
Beachwood, Ohio, 44122, United States
Patient Priority Clinical sites, LLC
Cincinnati, Ohio, 45242, United States
Midwest Clinical Research Center
Dayton, Ohio, 45408, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Summit Research Network (Oregon), LLC
Portland, Oregon, 97210, United States
City Line Avenue Family Practice
Bala-Cynwyd, Pennsylvania, 19004, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Lincoln Research
Lincoln, Rhode Island, 02865, United States
Clinical NeuroScience Solutions, Inc.
Memphis, Tennessee, 38119, United States
FutureSearch Trials
Austin, Texas, 78756, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75231, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Radiant Research
Salt Lake City, Utah, 84107, United States
Psychiatric Alliance of The Blue Ridge
Charlottesville, Virginia, 22903, United States
NeuroScience, Inc.
Herndon, Virginia, 20170, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Summit Research Network (Seattle), LLC
Seattle, Washington, 98104, United States
Northbrooke Research Center
Brown Deer, Wisconsin, 53223, 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
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Affairs
- Organization
- Otsuka Pharmaceutical Development and 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, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2010
First Posted
January 20, 2010
Study Start
March 1, 2010
Primary Completion
October 1, 2011
Study Completion
November 1, 2011
Last Updated
November 2, 2015
Results First Posted
November 2, 2015
Record last verified: 2015-09