A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

Major Depressive Disorder Clinical Trial

Official title:

A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-4 Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158533
• Other study ID #: ALK5461-205
• Status: Completed
• Phase: Phase 3
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2019
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of ALKS 5461.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• High Dose ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
• Low Dose ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
• Placebo
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Locations

Country	Name	City	State
Australia	Alkermes Investigational Site	Brisbane	Queensland
Australia	Alkermes Investigational Site	Frankston	Victoria
Australia	Alkermes Investigational Site	Melbourne	Victoria
Australia	Alkermes Investigational Site	Towong	Queensland
Canada	Alkermes Investigational Site	Gatineau	Quebec
Canada	Alkermes Investigational Site	Penticton	British Columbia
Canada	Alkermes Investigational Site	Quebec
United States	Alkermes Investigational Site	Allentown	Pennsylvania
United States	Alkermes, Investigational Site	Alpharetta	Georgia
United States	Alkermes Investigational Site	Austin	Texas
United States	Alkermes Investigational Site	Baltimore	Maryland
United States	Alkermes Investigational Site	Baltimore	Maryland
United States	Alkermes Investigational Site	Berlin	New Jersey
United States	Alkermes Investigational Site	Birmingham	Alabama
United States	Alkermes Investigational Site	Brooklyn	New York
United States	Alkermes Investigational Site	Canton	Ohio
United States	Alkermes Investigational Site	Carson	California
United States	Alkermes Investigational Site	Chicago	Illinois
United States	Alkermes Investigational Site	Coral Springs	Florida
United States	Alkermes Investigational Site	Dayton	Ohio
United States	Alkermes Investigational Site	Decatur	Georgia
United States	Alkermes Investigational Site	Gainesville	Florida
United States	Alkermes Investigational Site	Hartford	Connecticut
United States	Alkermes Investigational Site	Houston	Texas
United States	Alkermes Investigational Site	Joliet	Illinois
United States	Alkermes Investigational Site	Lauderhill	Florida
United States	Alkermes Investigational Site	Lincoln	Rhode Island
United States	Alkermes Investigational Site	Media	Pennsylvania
United States	Alkermes Investigational Site	Middleton	Wisconsin
United States	Alkermes Investigational Site	Mount Kisco	New York
United States	Alkermes Investigational Site	National City	California
United States	Alkermes Investigational Site	New York	New York
United States	Alkermes Investigational Site	Newburgh	Indiana
United States	Alkermes Investigational Site	Norwich	Connecticut
United States	Alkermes Investigational Site	Oklahoma City	Oklahoma
United States	Alkermes Investigational Site	Oklahoma City	Oklahoma
United States	Alkermes Investigational Site	Orange	California
United States	Alkermes Investigational Site	Orlando	Florida
United States	Alkermes Investigational Site	Owensboro	Kentucky
United States	Alkermes Investigational Site	Philadelphia	Pennsylvania
United States	Alkermes Investigational Site	San Antonio	Texas
United States	Alkermes Investigational Site	Sherman Oaks	California
United States	Alkermes Investigational Site	Skokie	Illinois
United States	Alkermes Investigational Site	Staten Island	New York
United States	Alkermes Investigational Site	Torrance	California
United States	Alkermes Investigational Site	Tucson	Arizona
United States	Alkermes Investigational Site	Upland	California
United States	Alkermes Investigational Site	Valparaiso	Indiana
United States	Alkermes Investigational Site	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score	The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.	Baseline and 5 weeks for each stage
Secondary	Proportion of Patients Who Exhibited Treatment Response (MADRS-10)	The proportion of subjects demonstrating MADRS-10 treatment response, defined as a >/= 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (Week 5). The MADRS-10 scale is a measure of the severity of MDD symptoms and includes the following 10 items: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms).	Baseline and 5 weeks for each stage
Secondary	Remission Rate	The proportion of subjects achieving remission, defined as a MADRS-10 score of	Baseline and 5 weeks for each stage
Secondary	Number of Subjects With Adverse Events (AEs)		5 weeks for Stage 1 and 6 weeks for Stage 2