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A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)

NCT03188185 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2021-04-08

Study results available
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Summary

This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.

Conditions

Interventions

DRUG

ALKS 5461

Samidorphan + buprenorphine, administered sublingually

DRUG

ALKS 5461 Placebo

Placebo tablet, administered sublingually

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
2017-06-12
Primary Completion
2020-02-26
Completion
2020-03-05
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Puerto Rico

Study Locations

More Related Trials

Entities

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 NCT03188185 on ClinicalTrials.gov