Phase 3 Completed N=342 Randomized Quadruple-blind Treatment

A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study

Major Depressive Disorder

Source: ClinicalTrials.gov NCT02158546 ↗

Enrolled (actual)

342

Serious AEs

0.3%

Results posted

Jun 2019

Primary outcomePrimary: Change From Baseline to End of Treatment (Week 6) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score — -4.8; -4.6 units on a scale — p=0.782

◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 End of Treatment (Week 6) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score	-4.8; -4.6	0.782
SECONDARY Proportion of Patients Who Exhibited Treatment Response (MADRS-10)	24; 21	—
SECONDARY Remission Rate	20; 18	—
SECONDARY Number of Subjects With Adverse Events (AEs)	63; 51; 11; 8	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02158546). 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.