Study of Adjunctive Treatment of Major Depressive Disorder

  • STATUS
    Recruiting
  • sponsor
    Alkermes, Inc.
Updated on 23 November 2020

Summary

Study of Adjunctive Treatment of Major Depressive Disorder

Description

A Phase III, Multicenter Study of the Long-Term Safety and Tolerability of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults who have an Inadequate Response to Antidepressant Treatment

For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT02158533?term=alks5461-205&rank=1 or segaltrials.com

Details
Clinical Study IdentifierTX140946
SponsorAlkermes, Inc.
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive
Agree to use an acceptable method of contraception for the duration of the study
Have a Major Depressive Disorder (MDD) primary diagnosis
Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
Additional criteria may apply

Exclusion Criteria

Have a current primary Axis-I disorder other than MDD
Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
Have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during lifetime
Have attempted suicide within the past 2 years
Have a positive test for drugs of abuse
Are pregnant, planning to become pregnant, or breastfeeding
Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
Have had a significant blood loss or blood donation within 60 days
Additional criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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