A study to evaluate how safe and effective ALKS 5461 is in patients with major depressive disorder as add on therapy to the usual antidepressants.

Phase 1

• Conditions: Major Depressive Disorder; MedDRA version: 17.1Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episodeSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2014-000379-14-PL
• Lead Sponsor: Alkermes, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-29
• Last Update Posted: 19 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

•Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m^2, inclusive
•Agree to use an acceptable method of contraception for the duration of the study
•Have a Major Depressive Disorder (MDD) primary diagnosis
•Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
•Additional criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 446
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

•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 one course of electroconvulsive treatment during lifetime
•Have attempted suicide within the past 2 years
•Have a positive test for drugs of abuse
•Are pregnant, planning to become pregnant, or breastfeeding
•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 60 days
•Additional criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified