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

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ClinicalTrials.gov Identifier: NCT01500200
Recruitment Status : Completed
First Posted : December 28, 2011
Results First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Major Depressive Disorder Drug: ALKS 5461 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALKS 5461 Drug: ALKS 5461
Two active tablets, given daily

Placebo Comparator: Placebo Drug: Placebo
Two placebo tablets, given daily




Primary Outcome Measures :
  1. Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total Score [ Time Frame: Baseline and 4 weeks for each stage ]
    The HAM-D17 scale is a clinician-administered questionnaire comprised of 17 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypochondriasis, insight, agitation, and retardation.


Secondary Outcome Measures :
  1. Proportion of Patients Who Exhibited Treatment Response (HAM-D17) [ Time Frame: 4 weeks for each stage ]
    The proportion of subjects demonstrating HAM-D17 treatment response, defined as a ≥ 50% reduction in HAM-D17 score from baseline to the end of the efficacy period (Week 4). The HAM-D17 is a clinician administered questionnaire comprised of 17 questions used to assess the severity of a patient's depression. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypochondriasis, insight, agitation, and retardation.

  2. Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: 4 weeks for each stage ]
    The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.

  3. Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score [ Time Frame: 4 weeks for each stage ]
    The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is at a specific point in time. Based on the scale, patients are categorized as follows: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients."



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500200


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

Publications of Results:
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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01500200     History of Changes
Other Study ID Numbers: ALK5461-202
First Posted: December 28, 2011    Key Record Dates
Results First Posted: May 21, 2019
Last Update Posted: May 21, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Pathologic Processes
Behavioral Symptoms
Naltrexone
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Alcohol Deterrents