Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alkermes, Inc.
The study will measure efficacy using the HAM-D-17, the MADRS, and the CGI-S as well as using other scales and assessments.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
Clareo Health | A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
