Phase 3
Completed N=617
Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder
Depressive Disorder, Major
Source: ClinicalTrials.gov NCT03002077 ↗
Enrolled (actual)
617
Serious AEs
4.5%
Results posted
Jun 2020
Primary outcomePrimary: The Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 457 Count of Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
457 | — |
| SECONDARY Change From Baseline in Brief Psychiatric Rating Scale Positive Symptoms Subscale (BPRS+) |
-0.0 | — |
| SECONDARY Change From Baseline in the Clinician Administered Dissociative States Scale (CADSS) |
-0.2 | — |
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 Screening
- 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 Screening
- 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 stress disorder
- MDD with psychotic features
- Significant suicide risk, as judged by the Investigator.
Data sourced from ClinicalTrials.gov (NCT03002077). 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.