A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-01)

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 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

NCT02932943

Run by

Naurex, Inc, an affiliate of Allergan plc

People needed

465

Starts

2016-10-15

Expected to finish

2018-11-08

Last updated by the study team

2019-10-11

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

Where it is running

• Southern California Research LLC. — Beverly Hills, California, United States
• ATP Clinical Research Inc. — Costa Mesa, California, United States
• Pharmacology Research Institute — Encino, California, United States
• Collaborative Neuroscience Network, LLC — Garden Grove, California, United States
• Synergy San Diego — Lemon Grove, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• Excell Research — Oceanside, California, United States
• Anderson Clinical Research — Redlands, California, United States
• Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc., — Sherman Oaks, California, United States
• Viking Clinical Research — Temecula, California, United States
• Pacific Clinical Research Medical — Upland, California, United States
• Comprehensive Psychiatric Care — Norwich, Connecticut, United States
• Meridien Research — Bradenton, Florida, United States
• MD Clinical — Hallandale, Florida, United States
• Clinical Neuroscience Solutions, Inc — Jacksonville, Florida, United States
• Meridien Research — Lakeland, Florida, United States
• Institute for Advanced Medical Research — Alpharetta, Georgia, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Adams Clinical Trials — Watertown, Massachusetts, United States
• Altea Research — Las Vegas, Nevada, United States
• Bioscience Research — Mount Kisco, New York, United States
• Eastside Comprehensive Medical Center, LLC — New York, New York, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• Neuro-Behavioral Clinical Research, Inc — Canton, Ohio, United States
• University of Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.