NCT05081167Phase 3Completed

A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)

Study sponsor: Relmada Therapeutics, Inc. · RLMD

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2022-09-13Actual

Enrollment · participants232Actual

Source updated2024-03-26Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Major Depressive Disorder

Treatments or interventions studied

REL-1017DrugAlso known as esmethadone
PlaceboDrug

Primary outcomes · main study measures

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measure: Change in the MADRS10 Total Score From Baseline to Day 28; description: Therapeutic efficacy of REL-1017 as monotherapy versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression. A negative change from baseline indicates improvement.; timeFrame: Day 28

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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