Phase 3
N=458
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-01)
Depressive Disorder, Major
Bottom Line
View on ClinicalTrials.gov: NCT02932943 ↗Enrolled (actual)
458
Serious AEs
0.4%
Results posted
Oct 2019
Primary outcome: Primary: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Trial — -5; -4.7 Score on a Scale — p=0.6482
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rapastinel (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Naurex, Inc, an affiliate of Allergan plc
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Trial |
-5; -4.7 | 0.6482 |
| SECONDARY Change From Baseline in MADRS Total Score |
-5.1; -5.5 | 0.5590 |
| SECONDARY Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population |
-4.6; -4.4 | 0.8131 |
| SECONDARY Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population |
-4.1; -4.5 | 0.6108 |
Summary
This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 mg compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.
Eligibility Criteria
Inclusion Criteria
- Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
- Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
- Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
- If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.
Exclusion Criteria
- DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
- Lifetime history of meeting DSM-5 criteria for:
- Schizophrenia spectrum or other psychotic disorder
- Bipolar or related disorder
- Major neurocognitive disorder
- Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
- Dissociative disorder
- Posttraumatic stess disorder
- MDD with psychotic features
- Significant suicide risk, as judged by the Investigator.
Data sourced from ClinicalTrials.gov (NCT02932943). 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.