A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)

Completed · Phase 3 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel, 225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.

Key facts

Study ID

NCT02943564

Run by

Naurex, Inc, an affiliate of Allergan plc

People needed

658

Starts

2016-11-01

Expected to finish

2018-12-18

Last updated by the study team

2019-12-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 stress disorder
• MDD with psychotic features
• Significant suicide risk, as judged by the Investigator.

Where it is running

• University of Arizona Department of Psychiatry — Tucson, Arizona, United States
• Woodland International Research Group — Little Rock, Arkansas, United States
• Woodland Research Northwest — Rogers, Arkansas, United States
• California Pharmaceutical Research Institute, Inc — Anaheim, California, United States
• ProScience Research Group — Culver City, California, United States
• Behavioral Research Specialists, LLC — Glendale, California, United States
• Synergy Clinical Research Center of Escondido — Lemon Grove, California, United States
• Pacific Research Partners; LLC. — Oakland, California, United States
• CITrials — Riverside, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• PCSD Feighner Research — San Diego, California, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• Reliable Clinical Research — Hialeah, Florida, United States
• Advanced Research Institute of Miami — Homestead, Florida, United States
• Innovative Clinical Research, Inc — Lauderhill, Florida, United States
• International Research Associates, LLC — Miami, Florida, United States
• Sarkis Clinical Trials — Ocala, Florida, United States
• Medical Research Group of Central Florida — Orange City, Florida, United States
• Clinical Neuroscience Solutions, Inc — Orlando, Florida, United States
• Millenia Psychiatry & Research, Inc — Orlando, Florida, United States
• iResearch Atlanta, LLC — Decatur, Georgia, United States
• IRIS Research — Smyrna, Georgia, United States
• Great Lakes Clinical Trials — Chicago, Illinois, United States
• Alexian Brothers Center for Psychiatric Research — Hoffman Estates, Illinois, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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