Clinical trial NCT01052077: Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: OPC-34712
Major Depressive Disorder
Adjunctive Treatment
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-20
Enrollment: 773
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

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
* Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.

Primary outcomes:
measure: 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.
timeFrame: Baseline (end of week 8) to Week 14
Secondary outcomes:
measure: Change From End of Phase A (Week 8) to Phase B in Sheehan Disability Scale (SDS) Score.
timeFrame: Baseline (end of week 8) to Week 14
measure: Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Trial Week Visit in Phase B.
timeFrame: Baseline (end of week 8) to Week 14
measure: 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.
timeFrame: Baseline (end of week 8) to Week 14
measure: 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.
timeFrame: Baseline (end of week 8) to Week 14
measure: 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.
timeFrame: Baseline (end of week 8) to Week 14
measure: Clinical Global Impression- Improvement Scale (CGI-I) Score by Study Week in Phase B Relative to End of Phase A.
timeFrame: Baseline (end of week 8) to Week 14
measure: Number of Participants With MADRS Response During Phase B Relative to the End of Phase A (Week 8) Visit.
timeFrame: Baseline (end of week 8) to Week 14
measure: Number of Participants With MADRS Remission During Phase B Relative to the End of Phase A (Week 8) Visit.
timeFrame: Baseline (end of week 8) to Week 14
measure: Number of Participants With CGI-Improvement Response During Phase B Relative to the End of Phase A (Week 8).
timeFrame: Baseline (end of week 8) to Week 14
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Arcadia
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Beverly Hills
country: United States
facility: Southwestern Research
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: San Diego
country: United States
facility: Affiliated Research Institute
state: California
city: Santa Ana
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc.
state: California
city: Coral Springs
country: United States
facility: CNS Clinical Research Group
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Atlanta
country: United States
facility: Comprehensive NeuroScience, Inc.
state: Georgia
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Indianapolis
country: United States
facility: Goldpoint Clinical Research, LLC
state: Indiana
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Glen Burnie
country: United States
facility: Clinical InSights
state: Maryland
city: Pikesville
country: United States
facility: Pharmasite Research, Inc.
state: Maryland
city: East Lansing
country: United States
facility: MSU/Institute for Health Studies
state: Michigan
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: New York
country: United States
facility: Eastside Comprehensive Medical Center
state: New York
city: New York
country: United States
facility: Medical & Behavioral Health Research, PC
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Beachwood
country: United States
facility: Northcoast Clinical Trials
state: Ohio
city: Cincinnati
country: United States
facility: Patient Priority Clinical sites, LLC
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network (Oregon), LLC
state: Oregon
city: Bala Cynwyd
country: United States
facility: City Line Avenue Family Practice
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Lincoln
country: United States
facility: Lincoln Research
state: Rhode Island
city: Memphis
country: United States
facility: Clinical NeuroScience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research
state: Utah
city: Charlottesville
country: United States
facility: Psychiatric Alliance of The Blue Ridge
state: Virginia
city: Herndon
country: United States
facility: NeuroScience, Inc.
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle), LLC
state: Washington
city: Brown Deer
country: United States
facility: Northbrooke Research Center
state: Wisconsin
Study officials:
References:
citation: 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.