Phase 2
N=769
Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01052077 ↗Enrolled (actual)
769
Serious AEs
0.8%
Results posted
Nov 2015
Primary outcome: Primary: 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. — -8.20; -7.02 Units on a scale — p=0.1416
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OPC-34712 (Drug); Placebo (Drug); ADT (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
-8.20; -7.02 | 0.1416 |
| SECONDARY Change From End of Phase A (Week 8) to Phase B in Sheehan Disability Scale (SDS) Score. |
-0.91; -0.69 | 0.3778 |
| SECONDARY Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Trial Week Visit in Phase B. |
-3.30; -1.99; -5.92; -4.01; -7.23; -5.22 | 0.0162 sig |
| SECONDARY 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. |
-0.29; -0.20; -0.58; -0.44; -0.76; -0.59 | 0.1481 |
| SECONDARY 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. |
-1.65; -1.99; -2.91; -2.93; -3.92; -3.64 | 0.6272 |
| SECONDARY 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. |
-5.98; -5.40 | 0.3247 |
| SECONDARY Clinical Global Impression- Improvement Scale (CGI-I) Score by Study Week in Phase B Relative to End of Phase A. |
3.33; 3.37; 3.03; 3.15; 3.00; 3.02 | 0.5616 |
| SECONDARY Number of Participants With MADRS Response During Phase B Relative to the End of Phase A (Week 8) Visit. |
11; 4; 29; 16; 41; 26 | 0.0679 |
| SECONDARY Number of Participants With MADRS Remission During Phase B Relative to the End of Phase A (Week 8) Visit. |
7; 3; 15; 7; 31; 18 | 0.2404 |
| SECONDARY Number of Participants With CGI-Improvement Response During Phase B Relative to the End of Phase A (Week 8). |
23; 19; 47; 39; 73; 51 | 0.4605 |
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.
Data sourced from ClinicalTrials.gov (NCT01052077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.