A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: Low Dose ALKS 5461Drug: High Dose ALKS 5461Drug: Placebo
- Registration Number
- NCT02158533
- Lead Sponsor
- Alkermes, Inc.
- Brief Summary
This study will evaluate the efficacy and safety of ALKS 5461.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 385
- 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
- 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
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low Dose Low Dose ALKS 5461 - High Dose High Dose ALKS 5461 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score Baseline and 5 weeks for each stage The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
- Secondary Outcome Measures
Name Time Method Proportion of Patients Who Exhibited Treatment Response (MADRS-10) Baseline and 5 weeks for each stage The proportion of subjects demonstrating MADRS-10 treatment response, defined as a \>/= 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (Week 5). The MADRS-10 scale is a measure of the severity of MDD symptoms and includes the following 10 items: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms).
Remission Rate Baseline and 5 weeks for each stage The proportion of subjects achieving remission, defined as a MADRS-10 score of \</= 10 at the end of the efficacy period.
Number of Subjects With Adverse Events (AEs) 5 weeks for Stage 1 and 6 weeks for Stage 2
Trial Locations
- Locations (2)
Alkermes Investigational Site
🇨🇦Quebec, Canada
Alkermes, Investigational Site
🇺🇸Alpharetta, Georgia, United States