A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 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-3 Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158546
• Other study ID #: ALK5461-206
• Status: Completed
• Phase: Phase 3
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: May 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: 447
• 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:
• 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
Bulgaria	Alkermes Investigational Site	Bourgas
Bulgaria	Alkermes Investigational Site	Kazanlak
Bulgaria	Alkermes Investigational Site	Sofia
Bulgaria	Alkermes Investigational Site	Sofia
Bulgaria	Alkermes Investigational Site	Sofia
Bulgaria	Alkermes Investigational Site	Varna
Bulgaria	Alkermes Investigational Site	Veliko Tarnovo
Bulgaria	Alkermes Investigational Site	Vratza
United States	Alkermes Investigational Site	Albuquerque	New Mexico
United States	Alkermes Investigational Site	Atlanta	Georgia
United States	Alkermes Investigational Site	Beachwood	Ohio
United States	Alkermes Investigational Site	Bellevue	Washington
United States	Alkermes Investigational Site	Bellflower	California
United States	Alkermes Investigational Site	Beverly Hills	California
United States	Alkermes Investigational Site	Brockton	Massachusetts
United States	Alkermes Investigational Site	Charleston	South Carolina
United States	Alkermes Investigational Site	Charlotte	North Carolina
United States	Alkermes Investigational Site	Cherry Hill	New Jersey
United States	Alkermes Investigational Site	Chicago	Illinois
United States	Alkermes Investigational Site	Cincinnati	Ohio
United States	Alkermes Investigational Site	Cincinnati	Ohio
United States	Alkermes Investigational Site	Dallas	Texas
United States	Alkermes Investigational Site	Dallas	Texas
United States	Alkermes Investigational Site	Edgewood	Kentucky
United States	Alkermes Investigational Site	Glendale	California
United States	Alkermes Investigational Site	Hallandale Beach	Florida
United States	Alkermes Investigational Site	Hialeah	Florida
United States	Alkermes Investigational Site	Houston	Texas
United States	Alkermes Investigational Site	Indianapolis	Indiana
United States	Alkermes Investigational Site	Jacksonville	Florida
United States	Alkermes Investigational Site	Jamaica	New York
United States	Alkermes Investigational Site	Kansas City	Missouri
United States	Alkermes Investigational Site	Lafayette	Indiana
United States	Alkermes Investigational Site	Leesburg	Florida
United States	Alkermes Investigational Site	Little Rock	Arkansas
United States	Alkermes Investigational Site	Los Alamitos	California
United States	Alkermes Investigational Site	Maitland	Florida
United States	Alkermes Investigational Site	Mason	Ohio
United States	Alkermes Investigational Site	Memphis	Tennessee
United States	Alkermes Investigational Site	Middleburg Heights	Ohio
United States	Alkermes Investigational Site	New York	New York
United States	Alkermes Investigational Site	O'Fallon	Missouri
United States	Alkermes Investigational Site	Oak Brook	Illinois
United States	Alkermes Investigational Site	Orange	California
United States	Alkermes Investigational Site	Philadelphia	Pennsylvania
United States	Alkermes Investigational Site	Portland	Oregon
United States	Alkermes Investigational Site	Redlands	California
United States	Alkermes Investigational Site	Saint Louis	Missouri
United States	Alkermes Investigational Site	Salem	Oregon
United States	Alkermes Investigational Site	Staten Island	New York
United States	Alkermes Investigational Site	Sugar Land	Texas
United States	Alkermes Investigational Site	Tampa	Florida
United States	Alkermes Investigational Site	Temecula	California
United States	Alkermes Investigational Site	Vernon Hills	Illinois
United States	Alkermes Investigational Site	Washington	District of Columbia
United States	Alkermes Investigational	Washington DC	Maryland
United States	Alkermes Investigational Site	Watertown	Massachusetts
United States	Alkermes Investigational Site	Waukesha	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to End of Treatment (Week 6) 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 week 6
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 6).	6 weeks
Secondary	Remission Rate	The proportion of subjects achieving remission, defined as a MADRS-10 score of = 10 at the end of the efficacy period.	6 weeks
Secondary	Number of Subjects With Adverse Events (AEs)		6 weeks