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Study of Rapastinel as Monotherapy in Major Depressive Disorder (MDD)

NCT03855865 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-07-19

No results posted yet for this study

Summary

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to 10 mg of Vortixetine and placebo in participants with major depressive disorder (MDD).

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Rapastinel

Rapastinel (prefilled syringe, weekly intravenous IV administration).

DRUG

Vortioxetine

Vortixetine (10 mg with available dose increase to vortioxetine 20 mg oral daily after 3 weeks of administration).

DRUG

Placebo

Placebo (prefilled syringe, weekly IV administration or oral daily).

Sponsors & Collaborators

  • Naurex, Inc, an affiliate of Allergan plc

    lead INDUSTRY

Principal Investigators

  • Marc Debelle · 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
2019-07-01
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

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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 NCT03855865 on ClinicalTrials.gov