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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT01500200
First received: December 22, 2011
Last updated: November 8, 2013
Last verified: November 2013
  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

Further study details as provided by Alkermes, Inc.:

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 ]

Enrollment: 142
Study Start Date: December 2011
Study Completion Date: March 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01500200     History of Changes
Other Study ID Numbers: ALK5461-202
Study First Received: December 22, 2011
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 23, 2014