Phase 3
Completed N=384
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study
Source: ClinicalTrials.gov NCT02158533 ↗Enrolled (actual)
384
Serious AEs
0.2%
Results posted
Mar 2019
Primary outcomePrimary: Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score — -11.1; -8.4; -13.0; -2.2 units on a scale — p=0.109
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate the efficacy and safety of ALKS 5461.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score |
-11.1; -8.4; -13.0; -2.2; -4.8; -3.9 | 0.109 |
| SECONDARY Proportion of Patients Who Exhibited Treatment Response (MADRS-10) |
79; 9; 20; 6; 9; 9 | — |
| SECONDARY Remission Rate |
47; 6; 13; 4; 7; 7 | — |
| SECONDARY Number of Subjects With Adverse Events (AEs) |
142; 34; 41; 29; 27; 29 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02158533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.