Major Depressive Disorder
Conditions
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel, multiple dose study designed to evaluate the safety and tolerability of the co-formulation of ALKS 33 with buprenorphine (ALKS 5461) in subjects with Major Depressive Disorder (MDD) who are inadequately/partially responding to current treatment with a stable dose of a serotonin-selective reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
Interventions
DRUGALKS 5461
Sublingual administration once daily for 7 consecutive days.
DRUGPlacebo
Sublingual administration once daily for 7 consecutive days.
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and female subjects between 18 and 65 years of age, inclusive. * Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for MDD. * Current episode lasting ≥8 weeks prior to screening with an inadequate/partial response to an adequate trial (defined as at least 8 weeks) of a stable dose of an SSRI or SNRI. Inadequate/partial response is defined as: 1. A Hamilton Depression Rating Scale total score (HAM-D17) ≥14, and 2. Less than 50% reduction in depressive symptom severity on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ), and 3. Clinical Global Impression - Severity (CGI-S) score of ≥3.
Exclusion criteria
* 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, or posttraumatic stress disorder. * A clinically significant current Axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder. * Experiencing hallucinations, delusions, or any psychotic symptomatology in the current episode. * The use of inducers or inhibitors of cytochrome P450 (CYP) 3A4 (prescription medications, over-the-counter \[OTC\] medications, or dietary supplements) within 30 days before dosing. * Have received electroconvulsive therapy during the current MDD episode. * Pose current suicide risk as confirmed by the Columbia Suicide Severity Rating Scale (C SSRS). * History of intolerance or hypersensitivity to buprenorphine. * History of allergy or hypersensitivity to opioid antagonists (eg, naltrexone, naloxone) or quinine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number and percent of subjects with treatment-emergent adverse events following sublingual administration of ALKS 33 and buprenorphine co-formulation (ALKS 5461) | 7 days | Measured over a range of dose levels in subjects with inadequate/partial response to antidepressant therapy during the current episode of MDD. |
Countries
United States
Outcome results
None listed