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.
Overview
- Phase
- Phase 2
- Intervention
- OPC-34712
- Conditions
- Major Depressive Disorder
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Enrollment
- 773
- Locations
- 42
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Brexipiprazole + ADT
OPC-34712 Tablets, Oral, 1 - 3 mg OPC-34712 + ADT
Intervention: OPC-34712
Brexipiprazole + ADT
OPC-34712 Tablets, Oral, 1 - 3 mg OPC-34712 + ADT
Intervention: Placebo
Brexipiprazole + ADT
OPC-34712 Tablets, Oral, 1 - 3 mg OPC-34712 + ADT
Intervention: ADT
Placebo + ADT
Placebo + ADT
Intervention: Placebo
Placebo + ADT
Placebo + ADT
Intervention: ADT
Outcomes
Primary Outcomes
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.
Time Frame: Baseline (end of week 8) to Week 14
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.
Secondary Outcomes
- 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) 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) 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)
- Number of Participants With MADRS Response During Phase B Relative to the End of Phase A (Week 8) Visit.(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)
- Number of Participants With MADRS Remission During Phase B Relative to the End of Phase A (Week 8) Visit.(Baseline (end of week 8) to Week 14)
- Number of Participants With CGI-Improvement Response During Phase B Relative to the End of Phase A (Week 8).(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)
- Clinical Global Impression- Improvement Scale (CGI-I) Score by Study Week in Phase B Relative to End of Phase A.(Baseline (end of week 8) to Week 14)