A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)

Major Depressive Disorder Clinical Trial

Official title:

A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Tolerability of Two Titration Schedules for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults With an Inadequate Response to Antidepressant Therapy (the FORWARD-1 Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085135
• Other study ID #: ALK5461-210
• Status: Completed
• Phase: Phase 3
• Start date: February 2014
• Est. completion date: September 2014

Study information

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

Clinical Trial Summary

This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Body mass index of 18-40 kg/m2

• Have a diagnosis of MDD

• Have a current major depressive episode (MDE) lasting 8 weeks to 24 months

• Have been treated with an adequate dose of an approved antidepressant during the current MDE for at least 8 weeks

• Have an inadequate response to current antidepressant treatment

• Agree to use an approved method of birth control for the duration of the study

• Additional criteria may apply

Exclusion Criteria:

• Currently pregnant or breastfeeding

• History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)

• Have experienced hallucinations, delusions, or any psychotic symptoms in the current MDE

• Have used opioid agonists (eg, codeine, oxycodone, tramadol, or morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days

• Have received electroconvulsive therapy treatment within the last 5 years

• Have attempted suicide within the past 2 years

• 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 with 60 days of screening

• 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

Locations

Country	Name	City	State
Canada	Alkermes Investigational Site	Halifax	Nova Scotia
United States	Alkermes Investigational Site	Allentown	Pennsylvania
United States	Alkermes Investigational Site	Atlanta	Georgia
United States	Alkermes Investigational Site	Bellevue	Washington
United States	Alkermes Investigational Site	Dayton	Ohio
United States	Alkermes Investigational Site	Jacksonville	Florida
United States	Alkermes Investigational Site	Orlando	Florida
United States	Alkermes Investigational Site	Saint Charles	Missouri
United States	Alkermes Investigational Site	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Adverse Events (AEs)		8 weeks