Phase 2
N=849
Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00797966 ↗Enrolled (actual)
849
Serious AEs
0.7%
Results posted
Dec 2015
Primary outcome: Primary: 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. — -6.62; -6.46; -8.23; -6.09 Units on a scale — p=0.6551
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
- Jun 2010
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 Montgomery Asberg Depression Rating Scale (MADRS) Total Score. |
-6.62; -6.46; -8.23; -6.09 | 0.6551 |
| SECONDARY 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. |
-0.83; -0.81; -1.06; -0.71 | 0.4166 |
| SECONDARY 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). |
7.60; 6.53; 7.46; 5.92 | 0.4490 |
| SECONDARY 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). |
-0.84; -0.80; -1.27; -0.61 | 0.4954 |
| SECONDARY 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. |
-2.13; -3.00; -2.75; -2.48; -3.69; -3.78 | — |
| SECONDARY 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. |
-0.21; -0.26; -0.33; -0.21; -0.42; -0.39 | — |
| SECONDARY 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). |
0.02; 0.01; 0.02; 0.00 | — |
| SECONDARY 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). |
0.30; 0.30; 0.35; 0.28 | — |
| SECONDARY 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. |
-0.98; -1.88; -2.04; -0.98; -2.13; -2.58 | — |
| SECONDARY 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. |
-5.77; -5.28; -6.59; -5.23 | 0.5953 |
| SECONDARY Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B. |
3.39; 3.30; 3.20; 3.31; 3.16; 3.19 | 0.3998 |
| SECONDARY Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit). |
4.92; 6.84; 2.59; 8.26; 8.06; 8.40 | 0.3007 |
| SECONDARY Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit). |
3.28; 1.71; 1.72; 4.13; 8.06; 5.04 | 0.5791 |
| SECONDARY Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit). |
16.1; 11.1; 14.7; 14.9; 25.8; 17.6 | 0.9462 |
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.
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 (NCT00797966). 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.