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Study of Rapastinel as Monotherapy in Patients With MDD

NCT03560518 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 439

Last updated 2020-09-01

Study results available
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Summary

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) and 900 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Rapastinel

Rapastinel (prefilled syringe, weekly intravenous IV administration)

DRUG

Placebo

Placebo (prefilled syringe, weekly IV administration)

Sponsors & Collaborators

  • Naurex, Inc, an affiliate of Allergan plc

    lead INDUSTRY

Principal Investigators

  • Jenna Hoogerheyde · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2019-07-08
Completion
2019-07-08
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 NCT03560518 on ClinicalTrials.gov