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

Completed · Phase 3

Conditions studied: Depressive Disorder, Major

In brief

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).

Key facts

Study ID

NCT03002077

Run by

Naurex, Inc, an affiliate of Allergan plc

People needed

617

Starts

2017-02-03

Expected to finish

2018-12-06

Last updated by the study team

2020-06-22

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 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 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 Screening
• 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, Inc. — Dothan, Alabama, United States
• NoesisPharma — Phoenix, 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
• Southern California Research LLC. — Beverly Hills, California, United States
• ATP Clinical Research Inc. — Costa Mesa, California, United States
• ProScience Research Group — Culver City, California, United States
• Collaborative Neuroscience Network, LLC — Garden Grove, California, United States
• Behavioral Research Specialists, LLC — Glendale, California, United States
• Sun Valley Research Center — Imperial, California, United States
• Irvine Center for Clinical Research, Inc — Irvine, California, United States
• Synergy Clinical Research Center of Escondido — Lemon Grove, California, United States
• Synergy San Diego — Lemon Grove, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• Pacific Research Partners; LLC. — Oakland, California, United States
• Excell Research — Oceanside, California, United States
• NRC Research Institute — Orange, California, United States
• Asclepes Research Centers — Panorama City, California, United States
• Anderson Clinical Research — Redlands, 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
• Artemis Institute for Clinical Research — San Marcos, California, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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