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Safety of REL-1017 for Major Depressive Disorder

NCT04855760 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 627

Last updated 2025-02-11

Study results available
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Summary

This was a 1-year, multicenter, open-label, long-term study to assess the safety of REL-1017 once daily (QD) as monotherapy or as adjunctive treatment of Major Depressive Disorder. Adjunctive study participants continued to take their current antidepressant therapy in addition to the study drug for the duration of the treatment period.

Conditions

Interventions

DRUG

REL-1017

REL-1017 tablet

Sponsors & Collaborators

  • Relmada Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Marco Pappagallo, MD · Relmada Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-07-27
Completion
2023-07-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04855760 on ClinicalTrials.gov