A study to evaluate how safe and effective ALKS 4561 is in patients with major depressive disorder as add on therapy to the usual antidepressants.

A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-5 Study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000379-14-DE

Enrollment

470

Registered

2014-06-11

Start date

2014-11-10

Completion date

Unknown

Last updated

2017-10-30

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: 19.0 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: •Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m^2, 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 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 446 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: • To evaluate the efficacy of ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD) in adults who have an inadequate response to antidepressant therapy (ADT) • To evaluate the safety and tolerability of ALKS 5461 in adults who have MDD and an inadequate response to ADT;Secondary Objective: NA;Primary end point(s): The primary efficacy endpoint will be the change from baseline to the end of the efficacy period in Montgomery - Asberg Depression Rating Scale (MADRS). ;Timepoint(s) of evaluation of this end point: Efficacy will be assessed as follows: Montgomery - Asberg Depression Rating Scale (MADRS) - all site visits during the treatment period (except FU on Day 85)	—

Measure

Time frame

Main Objective: • To evaluate the efficacy of ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD) in adults who have an inadequate response to antidepressant therapy (ADT) • To evaluate the safety and tolerability of ALKS 5461 in adults who have MDD and an inadequate response to ADT;Secondary Objective: NA;Primary end point(s): The primary efficacy endpoint will be the change from baseline to the end of the efficacy period in Montgomery - Asberg Depression Rating Scale (MADRS). ;Timepoint(s) of evaluation of this end point: Efficacy will be assessed as follows: Montgomery - Asberg Depression Rating Scale (MADRS) - all site visits during the treatment period (except FU on Day 85)

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Secondary

Measure	Time frame
Secondary end point(s): Safety and tolerability will be assessed on the basis of: • Treatment-emergent adverse events (TEAEs) • Clinical laboratory results • Vital signs • Weight • ECG results • C-SSRS results • COWS, as applicable.;Timepoint(s) of evaluation of this end point: at all visits	—

Countries

Germany, Poland, 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