Phase 3
Completed N=2,944
Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)
Source: ClinicalTrials.gov NCT01360866 ↗Enrolled (actual)
2,944
Serious AEs
2.4%
Results posted
Sep 2018
Primary outcomePrimary: Adverse Events (AEs) - All Participants — 400; 511; 1165; 51 Participants
◆ Published Evidence
Emerging
13citations · ~2 / year
Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies.
Summary
To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)
Linked Publications (2)
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Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies.
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Changes in Metabolic Parameters and Body Weight in Patients With Prediabetes Treated With Adjunctive Brexpiprazole for Major Depressive Disorder: Pooled Analysis of Short- and Long-Term Clinical Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events (AEs) - All Participants |
400; 511; 1165; 51; 399; 510 | — |
| SECONDARY Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score |
-0.77; -0.63; -0.48; -0.93 | — |
| SECONDARY Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score |
2.60; 2.63; 2.63; 2.40 | — |
| SECONDARY Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score |
-0.80; -0.70; -0.40; -1.00 | — |
| SECONDARY Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score |
-5.25; -4.76; -3.94; -7.44 | — |
Eligibility Criteria
Inclusion Criteria
- Male and Female outpatients 18-65 years of age
Eligible subjects from Trials 331-10-227, 331-10-228 or 331-12-282:
- Subjects who completed participation in the Double-blind Randomization Phase (i.e. Week 14 visit) in Trial 331-10-227, Trial 331-10-228, or Trial 331-12-282 or
- Subjects who met criteria for a response, but did not meet criteria for remission at Week 14 of either trial
Eligible subjects from other Phase 3, Double-blind, Brexpiprazole MDD trials:
- Subjects who completed the last scheduled visit of the prior Double-blind Randomized Phase 3 trial.
Exclusion Criteria
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving OPC-34712.
- Subjects with a major protocol violation during the course of their participation in the Double-blind Randomization Phase
Data sourced from ClinicalTrials.gov (NCT01360866) and the linked publication. 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.