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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.

Tracking Information
First Submitted Date  ICMJE December 22, 2011
First Posted Date  ICMJE December 28, 2011
Results First Submitted Date  ICMJE March 1, 2019
Results First Posted Date  ICMJE May 21, 2019
Last Update Posted Date May 21, 2019
Study Start Date  ICMJE December 2011
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 27, 2011)
Change from baseline in Hamilton rating scale for depression (HAM-D-17) total score [ Time Frame: 4 weeks ]
Change History Complete list of historical versions of study NCT01500200 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • 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.
  • 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.
  • 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."
Original Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2011)
  • Treatment response rate at end of 4-week treatment period [ Time Frame: 4 weeks ]
  • Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: 4 weeks ]
  • Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score [ Time Frame: 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
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
    Two active tablets, given daily
  • Drug: Placebo
    Two placebo tablets, given daily
Study Arms  ICMJE
  • Experimental: ALKS 5461
    Intervention: Drug: ALKS 5461
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Fava M, Memisoglu A, Thase ME, Bodkin JA, Trivedi MH, de Somer M, Du Y, Leigh-Pemberton R, DiPetrillo L, Silverman B, Ehrich E. Opioid Modulation With Buprenorphine/Samidorphan as Adjunctive Treatment for Inadequate Response to Antidepressants: A Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2016 May 1;173(5):499-508. doi: 10.1176/appi.ajp.2015.15070921. Epub 2016 Feb 12.

*   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: November 8, 2013)
142
Original Estimated Enrollment  ICMJE
 (submitted: December 27, 2011)
130
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01500200
Other Study ID Numbers  ICMJE ALK5461-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alkermes, Inc.
Study Sponsor  ICMJE Alkermes, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Richard Leigh-Pemberton, MD Alkermes, Inc.
PRS Account Alkermes, Inc.
Verification Date April 2019

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