Phase 2
Completed N=769
Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder
Source: ClinicalTrials.gov NCT01052077 ↗Enrolled (actual)
769
Serious AEs
0.8%
Results posted
Nov 2015
Primary outcomePrimary: 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
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.
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 |
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. Informational only — not medical advice.