Clinical trial NCT02085135: A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: depression
major depressive disorder
Alkermes
ALKS 5461
samidorphan
buprenorphine
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-12
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects With Adverse Events (AEs)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Orlando
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Saint Charles
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Staten Island
country: United States
facility: Alkermes Investigational Site
state: New York
city: Dayton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Allentown
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Bellevue
country: United States
facility: Alkermes Investigational Site
state: Washington
city: Halifax
country: Canada
facility: Alkermes Investigational Site
state: Nova Scotia
Study officials:
affiliation: Alkermes, Inc.
name: Sanjeev Pathak, MD
role: STUDY_DIRECTOR
References: