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A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder

NCT03352453 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2020-08-14

Study results available
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Summary

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who are at imminent risk of suicide.

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Rapastinel

Rapastinel pre-filled syringes for weekly IV injections.

DRUG

Placebo

Placebo-matching rapastinel pre-filled syringes for weekly IV injections.

Sponsors & Collaborators

  • Naurex, Inc, an affiliate of Allergan plc

    lead INDUSTRY

Principal Investigators

  • Jenna Hoogerheyde · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2019-06-21
Completion
2019-06-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03352453 on ClinicalTrials.gov