Clinical Trial Details

Overview

Research Study Summary

An Open-label, Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder

Purpose
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).
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CW ID: 223461
Date Last Changed: March 13, 2017

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
18 to 65 Years
Overall Status
Recruiting
Lead Sponsor
Allergan
Facility Type
N/A

Eligibility

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 ß-human chorionic gonadotropin (ß-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:
    1. Schizophrenia spectrum or other psychotic disorder
    2. Bipolar or related disorder
    3. Major neurocognitive disorder
    4. 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
    5. Dissociative disorder
    6. Posttraumatic stress disorder
    7. MDD with psychotic features
  • Significant suicide risk, as judged by the Investigator.

Contact

Colleen Figueroa
University of South Florida - USF Health Psychiatry Center
3515 E Fletcher Ave.
Tampa, FL 33613
Phone: (813) 974-9104

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