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

NCT03614156 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 363

Last updated 2020-10-09

Study results available
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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).

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Rapastinel

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

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
2018-08-02
Primary Completion
2019-07-11
Completion
2019-07-11
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • Japan
  • Poland
  • Slovakia

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 NCT03614156 on ClinicalTrials.gov