A study to evaluate how safe and effective ALKS 5461 is in patients with major depressive disorder as add on therapy to the usual antidepressants when given for a long period

A Phase 3 Multicenter Study of the Long-term Safety and Tolerability of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults who Have an Inadequate Response to Antidepressant Therapy (the FORWARD-2 Study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000380-41-HU

Enrollment

1700

Registered

2014-07-03

Start date

2014-09-30

Completion date

Unknown

Last updated

2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder MedDRA version: 17.1 Level: LLT Classification code 10025454 Term: Major depressive disorder, recurrent episode System Organ Class: 100000004873

Interventions

Product Name: ALKS 5461 2mg/2mg Product Code: ALKS 5461 Pharmaceutical Form: Tablet INN or Proposed INN: BUPRENORPHINE CAS Number: 53152-21-9 Current Sponsor code: NA Other descriptive name: BUPRENOR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Agree to use an approved method of contraception for the duration of the study 2. Have the potential to safely benefit from the administration of ALKS 5461 3. Have a diagnosis of major depressive disorder (MDD) 4. Additional criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1615 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 85

Exclusion criteria

Exclusion criteria: 1. Have a positive test for drugs of abuse 2. Currently pregnant or breastfeeding 3. Have a current primary Axis-I disorder other than MDD 4. Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days 5. Have received electroconvulsive therapy treatment within the last 2 years, or received more than 1 course of electroconvulsive treatment during their lifetime 6. Have attempted suicide within the past 2 years 7. Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone) 8. Have had a significant blood loss or blood donation within the past 60 days 9. Additional criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the long-term safety and tolerability of ALKS 5461 for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD);Secondary Objective: NA;Primary end point(s): Safety and tolerability analyses will be performed using data from the safety population, defined as all subjects who receive at least 1 dose of ALKS 5461. Reported AE terms will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms and system organ class categories. Safety assessments will be summarized using descriptive statistics along with supportive listings.;Timepoint(s) of evaluation of this end point: at all visits	—

Measure

Time frame

Main Objective: To assess the long-term safety and tolerability of ALKS 5461 for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD);Secondary Objective: NA;Primary end point(s): Safety and tolerability analyses will be performed using data from the safety population, defined as all subjects who receive at least 1 dose of ALKS 5461. Reported AE terms will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms and system organ class categories. Safety assessments will be summarized using descriptive statistics along with supportive listings.;Timepoint(s) of evaluation of this end point: at all visits

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Secondary

Measure	Time frame
Secondary end point(s): ALKS 5461 treatment effect over time will be assessed in an exploratory manner based on change from baseline in Montgomery - Asberg Depression Rating Scale (MADRS) total score, HAM-A score, and CGI-S score.;Timepoint(s) of evaluation of this end point: Montgomery - Asberg Depression Rating Scale (MADRS) at: all site visits HAM-A at: baseline, week 4, week 8, week 14, week 26, week 38, week 52, CGI-S at: all visits during the treatment period	—

Measure

Time frame

Secondary end point(s): ALKS 5461 treatment effect over time will be assessed in an exploratory manner based on change from baseline in Montgomery - Asberg Depression Rating Scale (MADRS) total score, HAM-A score, and CGI-S score.;Timepoint(s) of evaluation of this end point: Montgomery - Asberg Depression Rating Scale (MADRS) at: all site visits HAM-A at: baseline, week 4, week 8, week 14, week 26, week 38, week 52, CGI-S at: all visits during the treatment period

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Countries

Australia, Bulgaria, Canada, Germany, Hungary, Poland, Slovakia, United States

Contacts

Public ContactClinical Developement

Alkermes, Inc

william.martin@alkermes.com+1781-609-6012

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026