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A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

NCT02158533 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2019-08-14

Study results available
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Summary

This study will evaluate the efficacy and safety of ALKS 5461.

Conditions

Interventions

DRUG

High Dose ALKS 5461

Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

DRUG

Low Dose ALKS 5461

Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

DRUG

Placebo

Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Sanjeev Pathak, MD · Alkermes, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States
  • Australia
  • Canada

Study Locations

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Entities

Drugs
Diseases

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 NCT02158533 on ClinicalTrials.gov