Overview

This trial is active, not recruiting.

Condition major depressive disorder
Treatments high dose alks 5461, low dose alks 5461, placebo
Phase phase 3
Sponsor Alkermes, Inc.
Start date May 2014
End date February 2016
Trial size 350 participants
Trial identifier NCT02158533, ALK5461-205

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
high dose alks 5461 ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
(Experimental)
low dose alks 5461 ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
(Placebo Comparator)
placebo
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Primary Outcomes

Measure
Change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) total score
time frame: 11 weeks

Secondary Outcomes

Measure
Response during randomized treatment
time frame: 11 weeks
Remission during randomized treatment
time frame: 11 weeks
Safety and tolerability will be assessed by incidence of adverse events (AEs)
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, 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 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

Additional Information

Official title A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-4 Study)
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Alkermes, Inc..