Clinical trial NCT01500200: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-28
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total Score
timeFrame: Baseline and 4 weeks for each stage
Secondary outcomes:
measure: Proportion of Patients Who Exhibited Treatment Response (HAM-D17)
timeFrame: 4 weeks for each stage
measure: Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: 4 weeks for each stage
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score
timeFrame: 4 weeks for each stage
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Alkermes Investigational Site
state: Arizona
city: Oceanside
country: United States
facility: Alkermes Investigational Site
state: California
city: Santa Ana
country: United States
facility: Alkermes Investigational Site
state: California
city: Torrance
country: United States
facility: Alkermes Investigational Site
state: California
city: Fort Myers
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Lauderhill
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Leesburg
country: United States
facility: Alkermes Investigational Site
state: Florida
city: North Miami
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Hoffman Estates
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Baltimore
country: United States
facility: Alkermes Investigational Site
state: Maryland
city: Boston
country: United States
facility: Alkermes Investigational Site
state: Massachusetts
city: Haverhill
country: United States
facility: Alkermes Investigational Site
state: Massachusetts
city: Berlin
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: Alkermes Investigational Site
state: New York
city: New York
country: United States
facility: Alkermes Investigational Site
state: New York
city: Canton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Alkermes Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Alkermes Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Dallas
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Houston
country: United States
facility: Alkermes Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Bellevue
country: United States
facility: Alkermes Investigational Site
state: Washington
Study officials:
affiliation: Alkermes, Inc.
name: Richard Leigh-Pemberton, MD
role: STUDY_DIRECTOR
References:
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.