Phase 3
Completed N=1,532
Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)
Source: ClinicalTrials.gov NCT01360632 ↗Enrolled (actual)
1,532
Serious AEs
0.3%
Results posted
Jan 2016
Primary outcomePrimary: Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set — -7.65; -7.98; -6.45 Units on a scale — p=0.0925
Summary
To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set |
-7.65; -7.98; -6.45 | 0.0925 |
| PRIMARY Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol |
-7.64; -8.29; 6.33 | 0.0737 |
| SECONDARY Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Set |
-3.25; -2.53; -2.19; -5.34; -4.8; -3.91 | 0.0096 sig |
| SECONDARY Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Per Final Protocol |
-3.09; -2.6; -2.18; -5.12; -4.92; -3.95 | 0.0286 sig |
| SECONDARY Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Scores for the Efficacy Sample Set |
-1.13; -0.67; -0.58; -1.33; -1.21; -0.84 | 0.0008 sig |
| SECONDARY Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in SDS Mean Scores for the Efficacy Sample Per Final Protocol |
-1.11; -0.74; -0.53; -1.27; -1.26; -0.78 | 0.0015 sig |
| SECONDARY Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set |
-1.00; -0.18; -0.55; -1.16; -0.91; -0.73 | 0.0377 sig |
| SECONDARY Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set Per Final Protocol |
-1.01; -0.20; -0.48; -1.11; -0.93; -0.65 | 0.0341 sig |
| SECONDARY Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical Global Impression Severity of Illness (CGI-S) for the Efficacy Sample Set |
-0.25; -0.22; -0.16; -0.52; -0.46; -0.31 | 0.0436 sig |
| SECONDARY Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical CGI-S for the Efficacy Sample Per Final Protocol |
-0.24; -0.23; -0.16; -0.5; -0.47; -0.33 | 0.0817 |
| SECONDARY Mean 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 for the Efficacy Sample Set |
-3.58; -2.68; -2.31; -4.97; -4.00; -3.11 | 0.0228 sig |
| SECONDARY Mean Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in IDS-SR Total Score for the Efficacy Sample Per Final Protocol |
-3.27; -2.65; -2.15; -4.7; -4.13; -2.94 | 0.0496 sig |
| SECONDARY Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) Hamilton Depression Scale 17 Item Version (HAM)-D17 Total Score for the Efficacy Sample Set |
-5.47; -6.14; -4.8 | 0.1732 |
| SECONDARY Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in HAM-D17 Total Score for the Efficacy Sample Set Per Final Protocol |
-5.36; -6.26; -4.57 | 0.1226 |
| SECONDARY Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Anxiety Rating Scale (HAM-A) Total Score for the Efficacy Sample Set |
-3.43; -3.89; -3.33 | 0.8164 |
| SECONDARY Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in HAM-A Total for the Efficacy Sample Per Final Protocol |
-3.35; -3.96; -3.07 | 0.5192 |
| SECONDARY Mean CGI-I Score at Each Trial Week Visit in Phase B for the Efficacy Sample Set |
3.36; 3.4; 3.51; 3.08; 3.09; 3.34 | 0.0248 sig |
| SECONDARY Mean CGI-I Score at Each Trial Week Visit in Phase B for the Efficacy Sample Per Final Protocol |
3.39; 3.42; 3.54; 3.1; 3.08; 3.35 | 0.0275 sig |
| SECONDARY Percentage of Participants With a MADRS Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Set |
4.5; 0.45; 2.8; 10.2; 6.19; 5.05 | 0.5279 |
| SECONDARY Percentage of Participants With a MADRS Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Per Final Protocol |
3.37; 0.48; 3.02; 7.58; 6.1; 4.93 | 0.7993 |
| SECONDARY Percentage of Participants With a MADRS Remission During Phase B Relative to the End of Phase A (Week 8) for the Efficacy Sample Set |
3.15; 0.45; 2.8; 4; 2.65; 4.13 | 0.9498 |
| SECONDARY Percentage of Participants With a MADRS Remission During Phase B Relative to the End of Phase A (Week 8) for the Efficacy Sample Per Final Protocol |
1.92; 0.48; 3.02; 2.37; 2.82; 3.94 | 0.3867 |
| SECONDARY Percentage of Participants With a CGI-I Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Set |
9.46; 10.4; 6.54; 23.6; 23; 13.3 | 0.2873 |
| SECONDARY Percentage of Participants With a CGI-I Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Per Final Protocol |
7.69; 9.52; 5.53; 21.8; 23; 12.3 | 0.5836 |
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 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 (NCT01360632). 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.