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Open Label Study to Assess the Safety of REL-1017 for Major Depressive Disorder (RELIANCE-OLS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04855760
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : April 22, 2021
Information provided by (Responsible Party):
Relmada Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: REL-1017 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety of REL-1017 as Adjunctive Treatment of Major Depressive Disorder
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: REL-1017 25 mg
Participants will take 1 tablet of REL-1017 25 mg, orally, per day in addition to their ongoing antidepressant (ADT).
Drug: REL-1017
REL-1017 tablet

Primary Outcome Measures :
  1. Safety and tolerability of REL-1017 as incidence of treatment emergent adverse events (TEAEs) [ Time Frame: 52 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 NMDAR- antagonist study, or received esketamine at any time.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04855760

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Contact: Medical Director (332) 900-5901

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United States, Massachusetts
Relmada Site 117 Recruiting
Watertown, Massachusetts, United States, 02472
United States, New Jersey
Relmada Site 122 Recruiting
Marlton, New Jersey, United States, 08053
Sponsors and Collaborators
Relmada Therapeutics, Inc.
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Study Director: Marco Pappagallo, MD Relmada Therapeutics
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Responsible Party: Relmada Therapeutics, Inc. Identifier: NCT04855760    
Other Study ID Numbers: REL-1017-310
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Relmada Therapeutics, Inc.:
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms