Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alkermes, Inc.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Have a Major Depressive Disorder (MDD) primary diagnosis
Have a body mass index (BMI) of 18.0 to \</= 40.0 kg/m\^2
Be willing and able to follow the study procedures and visits as outlined in the protocol (including agreeing not to enroll in any other clinical trials)
Have inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
Additional criteria may apply
You may not be if
Has any finding that would compromise the safety of the subject or affect their ability to adhere to the protocol visit schedule or fulfill visit requirements
Has any other significant medical condition (eg, neurological, psychiatric, or metabolic) or clinical symptom that could unduly risk the subject or affect the interpretation of study data
Has any current primary diagnosis other than MDD, where primary diagnosis is defined as the primary source of current distress and functional impairment
Has experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
Has been hospitalized for MDD within 3 months before screening
Has used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days prior to screening
Has received electroconvulsive therapy treatment within the last 2 years or within the current MDE or failed a course of electroconvulsive treatment at any time
Has a significant risk for suicide
Has a positive breath alcohol test at screening
Has a positive test for drugs of abuse at screening or visit 2
Is pregnant, planning to become pregnant, or is breastfeeding during the study
Additional criteria may apply
Clareo Health | A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)
