Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alkermes, Inc.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD
