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A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

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ClinicalTrials.gov Identifier: NCT02158533
Recruitment Status : Completed
First Posted : June 9, 2014
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

June 5, 2014
June 9, 2014
March 2, 2016
May 2014
December 2015   (Final data collection date for primary outcome measure)
Change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) total score [ Time Frame: 11 weeks ]
Same as current
Complete list of historical versions of study NCT02158533 on ClinicalTrials.gov Archive Site
  • Response during randomized treatment [ Time Frame: 11 weeks ]
    Based on pre-specified decrease of MADRS total score
  • Remission during randomized treatment [ Time Frame: 11 weeks ]
    Based on pre-specified MADRS total score
  • Safety and tolerability will be assessed by incidence of adverse events (AEs) [ Time Frame: 12 weeks ]
  • Response during randomized treatment [ Time Frame: 11 weeks ]
    Based on pre-specified decrease of MADRS total score
  • Remission during randomized treatment [ Time Frame: 11 weeks ]
    Based on pre-specified MADRS total score
  • Safety and tolerability will be assessed by number and percentage of subjects with adverse events (AEs) [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study
A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-4 Study)
This study will evaluate the efficacy and safety of ALKS 5461.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: High Dose ALKS 5461
    Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
    Other Name: ALKS 5461
  • Drug: Low Dose ALKS 5461
    Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
    Other Name: ALKS 5461
  • Drug: Placebo
    Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
  • Experimental: High Dose
    Intervention: Drug: High Dose ALKS 5461
  • Experimental: Low Dose
    Intervention: Drug: Low Dose ALKS 5461
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
385
350
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   United States
 
 
NCT02158533
ALK5461-205
No
Not Provided
Not Provided
Alkermes, Inc.
Alkermes, Inc.
Not Provided
Study Director: Sanjeev Pathak, MD Alkermes, Inc.
Alkermes, Inc.
February 2016

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