This trial is active, not recruiting.

Condition major depressive disorder
Treatments alks 5461, placebo
Phase phase 3
Sponsor Alkermes, Inc.
Start date May 2014
End date May 2016
Trial size 670 participants
Trial identifier NCT02158546, ALK5461-206


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
alks 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
(Placebo Comparator)
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Primary Outcomes

Change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) total score
time frame: 10 weeks

Secondary Outcomes

Response during randomized treatment
time frame: 10 weeks
Remission during randomized treatment
time frame: 10 weeks
Safety and tolerability will be assessed by number and percentage of subjects with 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-3 Study)
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Alkermes, Inc..