Clinical trial NCT00797966: Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Official title: 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
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: 2008-11-25
Enrollment: 850
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: 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.

Detailed description: A comparison of the Fixed dose arm (OPC-31712, 0.15 mg) verses placebo was included as a general secondary efficacy variable and results for this dose group comparison are included under each of the Outcome Measures.

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 Montgomery Asberg Depression Rating Scale (MADRS) Total Score.
timeFrame: Week 8 to Week 14
Secondary outcomes:
measure: 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.
timeFrame: Week 8 to Week 14
measure: 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).
timeFrame: Week 8 to Week 14
measure: 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).
timeFrame: Week 8 to Week 14
measure: 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.
timeFrame: Week 8 to each of Week 9, 10, 11, 12 and 13.
measure: 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.
timeFrame: Week 8 to each of Week 9, 10, 11, 12 and 13.
measure: Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 15 Score (Satisfaction With Medication).
timeFrame: Week 8 to Week 14
measure: Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 16 Score (Overall Life Satisfaction).
timeFrame: Week 8 to Week 14
measure: Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.
timeFrame: Week 8 to each of Week 9, 10, 11, 12, 13 and 14
measure: Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Depression Rating Scale (HAM-D17) Score.
timeFrame: Week 8 to Week 14
measure: Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.
timeFrame: Week 8 to each of Week 9, 10, 11, 12, 13 and 14.
measure: Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).
timeFrame: Week 8 to each of Week 9, 10, 11, 12, 13 and 14.
measure: Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).
timeFrame: Week 8 to each of Week 9, 10, 11, 12, 13 and 14.
measure: Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).
timeFrame: Week 9, 10, 11, 12, 13 and 14.
Other outcomes:
Locations:
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: Escondido
country: United States
facility: Synergy Escondido
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network Inc.
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
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: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc.
state: California
city: Denver
country: United States
facility: Radiant Research Center
state: Colorado
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
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: Kissimee
country: United States
facility: Accurate Clinical Trials
state: Florida
city: Orlando
country: United States
facility: Clinical Neurosciences Solutions
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Tampa
country: United States
facility: University of South Florida College of Medicine Psychiatry Center
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center
state: Florida
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Chicago
country: United States
facility: Uptown Research Institute
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Midwest Center for Neurobehavioral Medicine
state: Illinois
city: Indianapolis
country: United States
facility: The Davis Clinic, PC
state: Indiana
city: Overland Park
country: United States
facility: Vince & Associates Clinical Research
state: Kansas
city: Baltimore
country: United States
facility: Pharmasite Research, Inc.
state: Maryland
city: Mount Kisco
country: United States
facility: Bioscience Research
state: New York
city: New York City
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: Charlotte
country: United States
facility: Carolinas HealthCare - Behavioral Heath Center
state: North Carolina
city: Beachwood
country: United States
facility: NorthCoast Clinical Trials, Inc
state: Ohio
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc
state: Ohio
city: Cinncinnati
country: United States
facility: Patient Priority Clinical Sites, LLC
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Middleburg Heights
country: United States
facility: NorthStar Medical Research, LLC
state: Ohio
city: Portland
country: United States
facility: Summitt Research Network (Oregon)
state: Oregon
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Columbia
country: United States
facility: USC School of Medicine- Department of Neuropsychiatry and Behavioral Science
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neurosciences Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: Austin
country: United States
facility: FutureSearch Clinical Trials
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research
state: Utah
city: Salt Lake City
country: United States
facility: Mood Disorders Clinic
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: Midlothian
country: United States
facility: Dominion Clinical Research
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
city: Middleton
country: United States
facility: Dean Foundation
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.