Phase 3
N=824
Study of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Pyxis Trial)
Depressive Disorder · Depression · Depressive Disorder, Major · Mood Disorders · Mental Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01360645 ↗Enrolled (actual)
824
Serious AEs
1.1%
Results posted
Nov 2015
Primary outcome: Primary: Change From Baseline (End of Phase A [Week 8]) to Week 14 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score for the Efficacy Sample. — -8.27; -5.15 Units on a scale — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OPC-34712 + ADT (Drug); Placebo + ADT (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (End of Phase A [Week 8]) to Week 14 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score for the Efficacy Sample. |
-8.27; -5.15 | 0.0001 sig |
| PRIMARY Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score for the Efficacy Sample Per the Final Protocol. |
-8.36; -5.15 | 0.0002 sig |
| SECONDARY Mean Change From Baseline (End of Phase A [Week 8]) to Week 14 in Sheehan Disability Scale (SDS) Score for the Efficacy Sample. |
-1.35; -0.91 | 0.0372 sig |
| SECONDARY Mean Change From Baseline (End of Phase A [Week 8]) to Week 14 in SDS Score for the Efficacy Sample Per the Final Protocol |
-1.35; -0.89 | 0.0349 sig |
| SECONDARY Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score by Trial Week for the Efficacy Sample. |
-3.15; -1.86; -5.15; -3.43; -6.69; -4.06 | 0.0080 sig |
| SECONDARY Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score by Trial Week for the Efficacy Sample Per the Final Protocol. |
-3.05; -1.74; -5.04; -3.52; -6.58; -4.17 | 0.0086 sig |
| SECONDARY Mean Clinical Global Impression-Improvement (CGI-I) Scale Score (End of Phase A [Week 8]) to Week 14 by Trial Week for the Efficacy Sample. |
3.41; 3.62; 3.17; 3.37; 3.03; 3.23 | 0.0022 sig |
| SECONDARY Mean CGI-I Scale Score (End of Phase A [Week 8]) to Week 14 by Trial Week for the Efficacy Sample Per the Final Protocol. |
3.44; 3.67; 3.21; 3.40; 3.07; 3.25 | 0.0010 sig |
| SECONDARY Change From Baseline (End of Phase A [Week 8]) to Week 14 in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score for the Efficacy Sample. |
-0.25; -0.12; -0.45; -0.31; -0.61; -0.40 | 0.0229 sig |
| SECONDARY Change From Baseline (End of Phase A [Week 8]) to Week 14 in CGI-S Scale Score for the Efficacy Sample Per the Final Protocol. |
-0.24; -0.09; -0.43; -0.32; -0.58; -0.42 | 0.0109 sig |
| SECONDARY Change From Baseline (End of Phase A [Week 8]) to Week 14 in the Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score for the Efficacy Sample. |
-3.02; -1.45; -4.17; -2.64; -5.41; -4.31 | 0.0139 sig |
| SECONDARY Change From Baseline (End of Phase A [Week 8]) to Week 14 in the IDS-SR Total Score for the Efficacy Sample Per the Final Protocol. |
-3.30; -1.59; -4.29; -3.13; -5.45; -4.73 | 0.0069 sig |
| SECONDARY Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample. |
-0.70; -0.42; -1.09; -0.90; -1.17; -0.67 | 0.3079 |
| SECONDARY Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Per the Final Protocol. |
-0.76; -0.58; -1.11; -0.96; -1.18; -0.69 | 0.5151 |
| SECONDARY Change From Baseline (End of Phase A [Week 8]) to Week 14 in Hamilton Depression (HAM-D) Rating Scale Total Score for the Efficacy Sample. |
-5.89; -3.55 | 0.0001 sig |
| SECONDARY Change From Baseline (End of Phase A [Week 8]) to Week 14 in HAM-D Rating Scale Total Score for the Efficacy Sample Per the Final Protocol. |
-5.89; -3.59 | 0.0002 sig |
| SECONDARY Change From Baseline (End of Phase A [Week 8]) to Week 14 in Hamilton Anxiety (HAM-A) Rating Scale Total Score for the Efficacy Sample |
-3.94; -2.77 | 0.0219 sig |
| SECONDARY Change From Baseline (End of Phase A [Week 8]) to Week 14 in HAM-A Rating Scale Total Score for the Efficacy Sample Per the Final Protocol. |
-3.79; -2.70 | 0.0376 sig |
| SECONDARY Percentage of Participants With MADRS Response at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample. |
23.5; 14.7 | 0.0176 sig |
| SECONDARY Percentage of Participants With MADRS Response at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol. |
23.4; 15.7 | 0.0429 sig |
| SECONDARY Percentage of Participants With MADRS Remission at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample. |
14.4; 8.38 | 0.0586 |
| SECONDARY Percentage of Participants With MADRS Remission at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol. |
14.9; 8.99 | 0.0671 |
| SECONDARY Percentage of Participants With CGI-I Scale Response Rate at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample. |
44.4; 27.7 | 0.0003 sig |
| SECONDARY Percentage of Participants With CGI-I Scale Response Rate at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol. |
43.4; 26.4 | 0.0002 sig |
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
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 (NCT01360645). 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.