A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03)

Completed · Phase 3 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams (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

NCT02943577

Run by

Naurex, Inc, an affiliate of Allergan plc

People needed

429

Starts

2016-11-02

Expected to finish

2018-11-21

Last updated by the study team

2019-11-13

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

• Harmonex Neuroscience Research — Dothan, Alabama, United States
• NoesisPharma — Phoenix, Arizona, United States
• Sun Valley Research Center — Imperial, California, United States
• Irvine Center for Clinical Research, Inc — Irvine, California, United States
• NRC Research Institute — Orange, California, United States
• Asclepes Research Centers — Panorama City, California, United States
• Artemis Institute for Clinical Research — San Marcos, California, United States
• MCB Clinical Research Center — Colorado Springs, Colorado, United States
• Gulfcoast Clinical Research Center — Fort Myers, Florida, United States
• Research Centers of America — Hollywood, Florida, United States
• Innova Clinical Trials Inc. — Miami, Florida, United States
• Combined Research Orlando Phase I-IV — Orlando, Florida, United States
• Olympian Clinical Research — Tampa, Florida, United States
• The University of South Florida Board of Trustees, A public Body Corporate, for University of South Florida — Tampa, Florida, United States
• Northwest Behavioral Research Center — Marietta, Georgia, United States
• AMR - Baber Research, Inc. — Naperville, Illinois, United States
• Psychiatric Associates — Overland Park, Kansas, United States
• Louisiana Clinical Research — Shreveport, Louisiana, United States
• Sheppard Pratt Health System — Baltimore, Maryland, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Psychiatric Care and Research Center — O'Fallon, Missouri, United States
• St. Charles Psychiatric Associates - Midwest Research Group — Saint Charles, Missouri, United States
• Alivation Research — Lincoln, Nebraska, United States
• Healthy Perspectives - Innovative Mental Health Services. PLLC — Nashua, New Hampshire, United States
• Hassman Research Institute, LLC — Berlin, New Jersey, United States

Full record on ClinicalTrials.gov

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