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A Long-Term Safety Study of ALKS 5461 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Long-Term Safety Study of ALKS 5461

A Phase 3 Multicenter Study of the Long-Term Safety and Tolerability of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults Who Have an Inadequate Response to Antidepressant Therapy (the FORWARD-2 Study)

NCT02141399•Alkermes, Inc.

View on ClinicalTrials.gov

Summary

This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Agree to use an approved method of contraception for the duration of the study
•Have the potential to safely benefit from the administration of ALKS 5461
•Have a diagnosis of major depressive disorder (MDD)
•Additional criteria may apply

Exclusion Criteria

•Have a positive test for drugs of abuse
•Currently pregnant or breastfeeding
•Have a current primary Axis-I disorder other than MDD
•Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
•Have received electroconvulsive therapy treatment within the last 2 years, or received more than 1 course of electroconvulsive treatment during their lifetime
•Have attempted suicide within the past 2 years
•Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
•Have had a significant blood loss or blood donation within the past 60 days
•Additional criteria may apply

Locations (158)

Alkermes Investigational Site

Birmingham, Alabama, United States

Alkermes Investigational Site

Birmingham, Alabama, United States

Alkermes Investigational Site

Tucson, Arizona, United States

Alkermes Investigational Site

Little Rock, Arkansas, United States

Alkermes Investigational Site

Bellflower, California, United States

Alkermes Investigational Site

Beverly Hills, California, United States

Alkermes Investigational Site

Carson, California, United States

Alkermes Investigational Site

Garden Grove, California, United States

Alkermes Investigational Site

Glendale, California, United States

Alkermes Investigational Site

Los Alamitos, California, United States

Key Dates

Start Date

May 1, 2014

Primary Completion Date

November 20, 2017

Completion Date

November 20, 2017

Last Updated

December 14, 2018

Enrollment

1,485

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

ALKS 5461

DRUG

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

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RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

NCT06793397

Major Depressive Disorder (MDD)Depression in Adults+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 14, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Long-Term Safety Study of ALKS 5461

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)