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A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alkermes
ClinicalTrials.gov Identifier:
NCT01500200
First received: December 22, 2011
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  Purpose

This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.


Condition Intervention Phase
Major Depressive Disorder
 Drug: ALKS 5461
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alkermes:

Primary Outcome Measures:
  • Change from baseline in Hamilton rating scale for depression (HAM-D-17) total score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment response rate at end of 4-week treatment period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) total score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Clinical Global Impression - Severity (CGI-S) total score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: December 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALKS 5461 Drug: ALKS 5461
Two active tablets, given daily
Placebo Comparator: Placebo Drug: Placebo
Two placebo tablets, given daily

Detailed Description:

The study will measure efficacy using the HAM-D-17, the MADRS, and the CGI-S as well as using other scales and assessments.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with a major depressive episode (MDE)
  • Body mass index less than or equal to 40 kg/m2
  • Have been treated with an adequate dose of SSRI/SNRI during the current MDE for at least 8 weeks, with the same, adequate dose over the last 4 weeks that is expected to remain stable throughout the study
  • History of inadequate response during the entire current MDE to 1 or 2 adequate antidepressant treatments, including current treatment
  • Be otherwise physically healthy

Exclusion Criteria:

  • Have an axis I diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar I or II disorder, eating disorder, obsessive-compulsive disorder, panic disorder, acute stress disorder, or posttraumatic stress disorder
  • Have a clinically significant current axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
  • Are experiencing hallucinations, delusions, or any psychotic symptomatology in the current MDE
  • Receive new onset psychotherapy within 6 weeks of screening
  • Use of opioid agonists (eg, codeine, oxycodone, morphine) within 14 days before screening
  • Have received electroconvulsive therapy during the current MDE
  • Have attempted suicide within the past 2 years
  • Have a thyroid pathology
  • Have a history of a seizure disorder or of neuroleptic malignant syndrome/serotonin syndrome
  • Have a positive test for human immunodeficiency virus (HIV)

Additional inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500200

  Show 27 Study Locations
Sponsors and Collaborators
Alkermes
Investigators
Study Director: Richard Leigh-Pemberton, MD Alkermes
  More Information

No publications provided

Responsible Party: Alkermes
ClinicalTrials.gov Identifier: NCT01500200     History of Changes
Other Study ID Numbers: ALK5461-202
Study First Received: December 22, 2011
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 19, 2013