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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALKS 5461
Placebo
Sponsored by
Alkermes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ALKS 5461

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total Score
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

Proportion of Patients Who Exhibited Treatment Response (HAM-D17)
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
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
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."

Full Information

First Posted
December 22, 2011
Last Updated
April 26, 2019
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01500200
Brief Title
A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
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 Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALKS 5461
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ALKS 5461
Intervention Description
Two active tablets, given daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two placebo tablets, given daily
Primary Outcome Measure Information:
Title
Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total Score
Description
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.
Time Frame
Baseline and 4 weeks for each stage
Secondary Outcome Measure Information:
Title
Proportion of Patients Who Exhibited Treatment Response (HAM-D17)
Description
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.
Time Frame
4 weeks for each stage
Title
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Description
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.
Time Frame
4 weeks for each stage
Title
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score
Description
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."
Time Frame
4 weeks for each stage

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Leigh-Pemberton, MD
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alkermes Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Alkermes Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Alkermes Investigational Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Alkermes Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Alkermes Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Alkermes Investigational Site
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Alkermes Investigational Site
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Alkermes Investigational Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Alkermes Investigational Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33716
Country
United States
Facility Name
Alkermes Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Alkermes Investigational Site
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Alkermes Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21285
Country
United States
Facility Name
Alkermes Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Alkermes Investigational Site
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Alkermes Investigational Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Alkermes Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11241
Country
United States
Facility Name
Alkermes Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Alkermes Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Alkermes Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Alkermes Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Alkermes Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Alkermes Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Alkermes Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Alkermes Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Alkermes Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Alkermes Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Alkermes Investigational Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26869247
Citation
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.
Results Reference
result

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

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