Safety of REL-1017 for Major Depressive Disorder (RELIANCE-OLS)

  • STATUS
    Recruiting
  • End date
    Jul 28, 2023
  • participants needed
    600
  • sponsor
    Relmada Therapeutics, Inc.
Updated on 28 May 2022

Summary

This is a 1-year open-label study to access the safety of REL-1017 once daily (QD) as an adjunctive treatment of Major Depressive Disorder. Study participants will continue to take their current antidepressant therapy in addition to the study drug for the duration of the treatment period.

Details
Condition Major Depressive Disorder
Treatment REL-1017
Clinical Study IdentifierNCT04855760
SponsorRelmada Therapeutics, Inc.
Last Modified on28 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults 18 to 65 years, inclusive
Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD
Current major depressive episode

Exclusion Criteria

Any current and primary psychiatric disorder other than Major Depressive Disorder
Severe alcohol or substance use disorder
History of bipolar I and II disorder, psychosis, and/or mania
Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study
Prior participation in a ketamine, esketamine, dextromethorphan or any other NMDARantagonist study, or received esketamine at any time
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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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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