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A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)

NCT02943564 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 658

Last updated 2019-12-27

Study results available
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Summary

This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel, 225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.

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
2016-11-01
Primary Completion
2018-12-12
Completion
2018-12-18
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 NCT02943564 on ClinicalTrials.gov