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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02085135
Recruitment Status : Completed
First Posted : March 12, 2014
Results First Posted : March 27, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Tracking Information
First Submitted Date  ICMJE March 7, 2014
First Posted Date  ICMJE March 12, 2014
Results First Submitted Date  ICMJE March 1, 2019
Results First Posted Date  ICMJE March 27, 2019
Last Update Posted Date August 14, 2019
Study Start Date  ICMJE February 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2019)
Number of Subjects With Adverse Events (AEs) [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
Safety and tolerability: Number and percent of subjects experiencing a treatment emergent adverse event (TEAE) [ Time Frame: 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)
Official Title  ICMJE 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)
Brief Summary This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: ALKS 5461
Sublingual tablet taken once daily
Study Arms  ICMJE
  • Experimental: Titration Schedule 1
    Intervention: Drug: ALKS 5461
  • Experimental: Titration Schedule 2
    Intervention: Drug: ALKS 5461
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2014)
66
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2014)
60
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02085135
Other Study ID Numbers  ICMJE ALK5461-210
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Alkermes, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Alkermes, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sanjeev Pathak, MD Alkermes, Inc.
PRS Account Alkermes, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP