A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 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-5 Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218008
• Other study ID #: ALK5461-207
• Status: Completed
• Phase: Phase 3
• Start date: July 2014
• Est. completion date: October 2016

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: 407
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Have a 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 an 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 their 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:
• 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
Canada	Alkermes Investigational Site	Gatineau
Canada	Alkermes Investigational Site	Halifax
Canada	Alkermes Investigational Site	Penticton
Canada	Alkermes Investigational Site	Quebec
Germany	Alkermes Investigational Site	Berlin
Germany	Alkermes Investigational Site	Berlin
Germany	Alkermes Investigational Site	Hannover
Germany	Alkermes Investigational Site	Oranienburg
Germany	Alkermes Investigational Site	Schwerin
Germany	Alkermes Investigational Site	Stralsund
Puerto Rico	Alkermes Investigational Site	San Juan
Puerto Rico	Alkermes Investigational Site	San Juan
United States	Alkermes Investigational Site	Bellevue	Washington
United States	Alkermes Investigational Site	Birmingham	Alabama
United States	Alkermes Investigational Site	Bradenton	Florida
United States	Alkermes Investigational Site	Canton	Ohio
United States	Alkermes Investigational Site	Clinton	Utah
United States	Alkermes Investigational Site	Colorado Springs	Colorado
United States	Alkermes Investigational Site	Colton	California
United States	Alkermes Investigational Site	DeSoto	Texas
United States	Alkermes Investigational Site	Flowood	Mississippi
United States	Alkermes Investigational Site	Fort Myers	Florida
United States	Alkermes Investigational Site	Garden Grove	California
United States	Alkermes Investigational Site	High Point	North Carolina
United States	Alkermes Investigational Site	Hoffman Estates	Illinois
United States	Alkermes Investigational Site	Los Angeles	California
United States	Alkermes Investigational Site	Melbourne	Florida
United States	Alkermes Investigational Site	Memphis	Tennessee
United States	Alkermes Investigational Site	New York	New York
United States	Alkermes Investigational Site	North Miami	Florida
United States	Alkermes Investigational Site	Oakland	California
United States	Alkermes Investigational Site	Oakland Park	Florida
United States	Alkermes Investigational Site	Oceanside	California
United States	Alkermes Investigational Site	Pico Rivera	California
United States	Alkermes Investigational Site	Portland	Oregon
United States	Alkermes Investigational Site	Princeton	New Jersey
United States	Alkermes Investigational Site	Saint Charles	Missouri
United States	Alkermes Investigational Site	Saint Louis	Missouri
United States	Alkermes Investigational Site	San Gabriel	California
United States	Alkermes Investigational Site	Seattle	Washington
United States	Alkermes Investigational Site	Smyrna	Georgia
United States	Alkermes Investigational Site	Spokane	Washington
United States	Alkermes Investigational Site	Wichita Falls	Texas
United States	Alkermes Investigational Site	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)	The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS-10 scale, comprised of the following individual questionnaire items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).	Baseline and 5 weeks (Stage 1) and baseline and 6 weeks (Stage 2), combined together for the overall estimate of treatment effect
Primary	Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)	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.	5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Primary	Change From Baseline to End of Treatment in the MADRS-10	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.	5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
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 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.	5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Secondary	Remission Rate	The proportion of subjects achieving remission, defined as a MADRS-10 score of =10 at the end of the efficacy period.	5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Secondary	Number of Subjects With Adverse Events (AEs)		5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)