Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)

Stopped early · Phase 3

Conditions studied: Depressive Disorder, Major

In brief

Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.

Key facts

Study ID

NCT03668600

Run by

Naurex, Inc, an affiliate of Allergan plc

People needed

230

Starts

2018-08-23

Expected to finish

2019-07-03

Last updated by the study team

2020-07-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completion of lead-in study
• Adequate therapeutic benefit in the lead-in study to justify continuation of treatment with rapastinel in the judgement of the investigator

You may not qualify if…

• Suicide risk, as determined by meeting any of the following criteria:
• A suicide attempt within the past year
• Significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the Columbia- Suicide Severity Rating Scale (C-SSRS) at any visit in the lead-in study
• Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 score ≥ 5 at any visit during participation in the lead-in study where MADRS was conducted.
• At imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator
• Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during participation
• Females of childbearing potential and male partners of females of childbearing potential, not using a reliable means of contraception

Where it is running

• Harmonex Neuroscience Research — 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
• Pharmacology Research Institute — Encino, 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
• Pharmacology Research Institute — Los Alamitos, California, United States
• CITrials — Riverside, California, United States
• California Neuroscience Research — 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
• Gulfcoast Clinical Research Center — Fort Myers, Florida, United States
• Reliable Clinical Research — Hialeah, Florida, United States
• Meridien Research — Lakeland, Florida, United States
• Innovative Clinical Research, Inc — Lauderhill, Florida, United States
• Research Centers of America — Oakland Park, Florida, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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