Last updated on June 2019

A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Endogenous depression | Major depression
  • Age: Between 18 - 70 Years
  • Gender: Male or Female

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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