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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Alkermes, Inc.
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total Score
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ALKS 5461
Intervention: ALKS 5461 (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Proportion of Patients Who Exhibited Treatment Response (HAM-D17)(4 weeks for each stage)
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score(4 weeks for each stage)
- Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score(4 weeks for each stage)