Phase 3
Completed N=406
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study
Source: ClinicalTrials.gov NCT02218008 ↗Enrolled (actual)
406
Serious AEs
0.7%
Results posted
Mar 2019
Primary outcomePrimary: Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) — -5.6; -6.0; -6.8; -1.5 Units on a scale — p=0.018
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) |
-5.6; -6.0; -6.8; -1.5; -2.2; -3.2 | 0.018 sig |
| PRIMARY Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) |
-8.1; -8.8; -10.3; -2.1; -3.2; -3.7 | 0.026 sig |
| PRIMARY Change From Baseline to End of Treatment in the MADRS-10 |
-9.2; -10.3; -10.8; -1.9; -3.4; -3.6 | 0.076 |
| SECONDARY Proportion of Patients Who Exhibited Treatment Response (MADRS-10) |
61; 17; 16; 7; 7; 6 | — |
| SECONDARY Remission Rate |
31; 8; 8; 4; 6; 5 | — |
| SECONDARY Number of Subjects With Adverse Events (AEs) |
151; 37; 42; 25; 29; 25 | — |
Eligibility Criteria
Inclusion Criteria
- Have a 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 an 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 their 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 (NCT02218008). 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.