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Completed

NCT Number: NCT02141399

A Long-Term Safety Study of ALKS 5461

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

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alkermes Investigational Site, Towong, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALKS 5461

Drug

Sublingual tablet, taken daily

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 56 weeks

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 19, 2014
Registry last updated
Dec 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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