A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
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
1 other identifier
interventional
142
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 major-depressive-disorder
Started Dec 2011
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 22, 2011
CompletedFirst Posted
Study publicly available on registry
December 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
May 21, 2019
CompletedMay 21, 2019
April 1, 2019
1.2 years
December 22, 2011
March 1, 2019
April 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline and 4 weeks for each stage
Secondary Outcomes (3)
Proportion of Patients Who Exhibited Treatment Response (HAM-D17)
4 weeks for each stage
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
4 weeks for each stage
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score
4 weeks for each stage
Study Arms (2)
ALKS 5461
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Study Sites (27)
Alkermes Investigational Site
Tucson, Arizona, 85712, United States
Alkermes Investigational Site
Oceanside, California, 92056, United States
Alkermes Investigational Site
Santa Ana, California, 92701, United States
Alkermes Investigational Site
Torrance, California, 90502, United States
Alkermes Investigational Site
Fort Myers, Florida, 33912, United States
Alkermes Investigational Site
Lauderhill, Florida, 33319, United States
Alkermes Investigational Site
Leesburg, Florida, 34748, United States
Alkermes Investigational Site
North Miami, Florida, 33161, United States
Alkermes Investigational Site
St. Petersburg, Florida, 33716, United States
Alkermes Investigational Site
Atlanta, Georgia, 30308, United States
Alkermes Investigational Site
Hoffman Estates, Illinois, 60169, United States
Alkermes Investigational Site
Baltimore, Maryland, 21285, United States
Alkermes Investigational Site
Boston, Massachusetts, 02135, United States
Alkermes Investigational Site
Haverhill, Massachusetts, 01830, United States
Alkermes Investigational Site
Berlin, New Jersey, 08009, United States
Alkermes Investigational Site
Brooklyn, New York, 11241, United States
Alkermes Investigational Site
New York, New York, 10021, United States
Alkermes Investigational Site
Canton, Ohio, 44718, United States
Alkermes Investigational Site
Dayton, Ohio, 45417, United States
Alkermes Investigational Site
Oklahoma City, Oklahoma, 73112, United States
Alkermes Investigational Site
Philadelphia, Pennsylvania, 19104, United States
Alkermes Investigational Site
Charleston, South Carolina, 29407, United States
Alkermes Investigational Site
Austin, Texas, 78754, United States
Alkermes Investigational Site
Dallas, Texas, 75235, United States
Alkermes Investigational Site
Houston, Texas, 77081, United States
Alkermes Investigational Site
San Antonio, Texas, 78229, United States
Alkermes Investigational Site
Bellevue, Washington, 98007, United States
Related Publications (1)
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.
PMID: 26869247RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Two subjects randomized to 8/8 received 2/2 and are presented in the Participant Flow, Baseline, and AE tables by actual treatment received. For the outcome measures, subjects were analyzed by randomization treatment assignment.
Results Point of Contact
- Title
- Eva Stroynowski
- Organization
- Alkermes
Study Officials
- STUDY DIRECTOR
Richard Leigh-Pemberton, MD
Alkermes, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2011
First Posted
December 28, 2011
Study Start
December 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
May 21, 2019
Results First Posted
May 21, 2019
Record last verified: 2019-04