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.

• Register: EUCTR
• Last refreshed on: 19 December 2016
• Main ID: EUCTR2014-000379-14-PL
• Date of registration: 29/08/2014
• Prospective Registration: Yes
• Primary sponsor: Alkermes, Inc.
• Public title: 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.
• Scientific title: A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-5 Study)
• Date of first enrolment: 17/10/2014
• Target sample size: 470
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000379-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Germany, Poland, United States

Contacts

• Name: Clinical Developement
• Affiliation: Alkermes, Inc

• Name: Clinical Developement
• Affiliation: Alkermes, Inc

Key inclusion & exclusion 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:
•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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Intervention(s)

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: BUPRENORPHINE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
INN or Proposed INN: Samidorphan
CAS Number: 1204592-75-5
Current Sponsor code: NA, it is within ALKS 5461
Other descriptive name: SAMIDORPHAN L-MALATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Sublingual use

Product Name: ALKS 5461 1mg/1mg
Product Code: ALKS 5461
Pharmaceutical Form: Tablet
INN or Proposed INN: BUPRENORPHINE
CAS Number: 53152-21-9
Current Sponsor code: NA
Other descriptive name: BUPRENORPHINE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: Samidorphan
CAS Number: 1204592-75-5
Current Sponsor code: NA, it is within ALKS 5461
Other descriptive name: SAMIDORPHAN L-MALATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Sublingual use

Product Name: ALKS 5461 0,5mg/0,5mg
Product Code: ALKS 5461
Pharmaceutical Form: Tablet
INN or Proposed INN: BUPRENORPHINE
CAS Number: 53152-21-9
Current Sponsor code: NA
Other descriptive name: BUPRENORPHINE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
INN or Proposed INN: Samidorphan
CAS Number: 1204592-75-5
Current Sponsor code: NA, it is within ALKS 5461
Other descriptive name: SAMIDORPHAN L-MALATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Sublingual use

Primary Outcome(s)

Secondary Objective: NA

Primary end point(s): The primary efficacy endpoint will be the change from baseline in
Montgomery - Asberg Depression Rating Scale (MADRS) total score.

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

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)

Secondary Outcome(s)

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

Secondary ID(s)

ALK5461-207

2014-000379-14-DE

Source(s) of Monetary Support

Alkermes, Inc.