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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ALKS 5461
Sponsored by
Alkermes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, major depressive disorder, Alkermes, ALKS 5461, samidorphan, buprenorphine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Titration Schedule 1

Titration Schedule 2

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects With Adverse Events (AEs)

Secondary Outcome Measures

Full Information

First Posted
March 7, 2014
Last Updated
August 2, 2019
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02085135
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, major depressive disorder, Alkermes, ALKS 5461, samidorphan, buprenorphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Titration Schedule 1
Arm Type
Experimental
Arm Title
Titration Schedule 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ALKS 5461
Intervention Description
Sublingual tablet taken once daily
Primary Outcome Measure Information:
Title
Number of Subjects With Adverse Events (AEs)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjeev Pathak, MD
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alkermes Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Alkermes Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Alkermes Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Alkermes Investigational Site
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Alkermes Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Alkermes Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Alkermes Investigational Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Alkermes Investigational Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Alkermes Investigational Site
City
Halifax
State/Province
Nova Scotia
Country
Canada

12. IPD Sharing Statement

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

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