Study of Rapastinel as Monotherapy in Patients With MDD

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) and 900 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).

Key facts

Study ID

NCT03560518

Run by

Naurex, Inc, an affiliate of Allergan plc

People needed

439

Starts

2018-06-15

Expected to finish

2019-07-08

Last updated by the study team

2020-09-01

Who can join

Age: 18 and older, up to 75. 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
• Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
• 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

• Alea Research — Phoenix, Arizona, United States
• Woodland International Research Group — Little Rock, Arkansas, United States
• California Pharmaceutical Research Institute, Inc. — Anaheim, California, United States
• Collaborative Neuroscience Network — Garden Grove, California, United States
• Synergy Research San Diego — National City, California, United States
• Excell Research Inc. — Oceanside, California, United States
• NRC Research Institute — Orange, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• California Neuroscience Research Medical Group,Inc. — Sherman Oaks, California, United States
• Viking Clinical Research Ltd. — Temecula, California, United States
• Pacific Clinical Research Medical Group — Upland, California, United States
• Research Centers of America, LLC — Hollywood, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Innovative Clinical Research, Inc. — Lauderhill, Florida, United States
• Innova Clinical Trials — Miami, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Institute for Advanced Medical Research — Atlanta, Georgia, United States
• iResearch Atlanta, LLC — Decatur, Georgia, United States
• Iris Research, Inc. — Smyrna, Georgia, United States
• Capstone Clinical Research — Libertyville, Illinois, United States
• Pharmasite Research, Inc. — Baltimore, Maryland, United States
• CBH Health, LLC — Gaithersburg, Maryland, United States
• Boston Clinical Trials — Boston, Massachusetts, United States
• Adams Clinical — Watertown, Massachusetts, United States
• Precise Research Centers — Flowood, Mississippi, United States

Full record on ClinicalTrials.gov

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