Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (MDD)

Phase 3

Terminated

• Conditions: Depressive Disorder, Major
• Interventions: Drug: Placebo; Drug: Rapastinel

• Registration Number: NCT03614156
• Lead Sponsor: Naurex, Inc, an affiliate of Allergan plc

Brief Summary

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225 mg of Rapastinel compared to placebo in the prevention of relapse in participants with major depressive disorder (MDD).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-07-30
• Study Start: 2018-08-02
• Study First Posted: 2018-08-03
• Primary Completion: 2019-07-11
• Study Completion: 2019-07-11
• Results First Submitted: 2020-07-10
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-16
• Last Update Submitted: 2020-09-16
• Results First Posted: 2020-10-09
• Last Update Posted: 2020-10-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 363

Inclusion Criteria

• Completion of Study RAP-MD-30, RAP-MD-31, or RAP-MD-32
• If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test

Exclusion Criteria

• 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:
• 1.Schizophrenia spectrum or other psychotic disorder
• 2.Bipolar or related disorder
• 3.Major neurocognitive disorder
• 4.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
• 5.Dissociative disorder
• 6.Posttraumatic stress disorder
• 7.MDD with psychotic features
• Significant suicide risk, as judged by the Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo weekly	Placebo	Placebo (prefilled syringe, weekly IV administration)
Rapastinel weekly	Rapastinel	Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)
Rapastinel clinically driven schedule	Rapastinel	Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)

Primary Outcome Measures

Name	Time	Method
Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP)	52 Weeks	The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.

Trial Locations

Locations (52)

Alea Research; 🇺🇸 Phoenix, Arizona, United States

Woodland International Research Group; 🇺🇸 Little Rock, Arkansas, United States

California Pharmaceutical Research Institute; 🇺🇸 Anaheim, 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

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