Safety of REL-1017 for Major Depressive Disorder
RELIANCE-OLS
A Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety of REL-1017 as a Treatment of Major Depressive Disorder
1 other identifier
interventional
627
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 major-depressive-disorder
Started Apr 2021
Typical duration for phase_3 major-depressive-disorder
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 19, 2021
CompletedFirst Posted
Study publicly available on registry
April 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2023
CompletedResults Posted
Study results publicly available
August 9, 2024
CompletedFebruary 11, 2025
January 1, 2023
2.3 years
April 19, 2021
July 16, 2024
January 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability of REL-1017 as Incidence of Treatment Emergent Adverse Events (TEAEs)
Subjects with at least one Treatment Emergent Adverse Events (TEAEs)
52 weeks
Secondary Outcomes (11)
Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 3
3 Month
Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 6
6 Month
Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 12
12 Month
Change in Diastolic Blood Pressure From Baseline to Month 3
3 Month
Change in Diastolic Blood Pressure From Baseline to Month 12
12 Month
- +6 more secondary outcomes
Other Outcomes (2)
Change in the MADRS10 Total Score From Baseline to Month 3
3 Month
Change in the MADRS10 Total Score From Baseline to Month 12
12 Month
Study Arms (1)
REL-1017
EXPERIMENTALRoll-over participants received 25 mg REL-1017 (one 25 mg REL-1017 tablet), orally, per day, either as a monotherapy or in addition to their ongoing antidepressant (ADT), rolling over from the monotherapy study REL-1017-303 or the adjunctive therapy studies REL-1017-301 and REL-1017-302, respectively. De Novo participants received a 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) on Day-1 of the 365-day treatment period. From Day-2 to Day-365, participants received 25 mg REL-1017 either as monotherapy or as adjunctive therapy.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any current and primary psychiatric disorder other than Major Depressive 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Relmada Site
Miami, Florida, 33015, United States
Relmada Site
Miami, Florida, 33175, United States
Relmada Site
Orlando, Florida, 32801, United States
Relmada Site
Palm Bay, Florida, 32905, United States
Relmada Site
Chicago, Illinois, 60634, United States
Relmada Site
Chicago, Illinois, 60640, United States
Relmada Site
Boston, Massachusetts, 02116, United States
Relmada Site
Watertown, Massachusetts, 02472, United States
Relmada Site
Staten Island, New York, 10312, United States
Related Publications (1)
Fava M, Pani L, De Martin S, Cutler AJ, Gorodetzky CW, Vocci FJ, Sapienza FL, Kosten TR, Kroger C, Champasa P, Guidetti C, Comai S, Mattarei A, Folli F, Bushnell D, Traversa S, Inturrisi CE, Manfredi PL, Pappagallo M. Long-Term Safety and Efficacy of Esmethadone in Patients With Major Depressive Disorder: Findings From a 12-Month Open-Label Study. J Clin Psychiatry. 2025 Feb 17;86(1):24m15438. doi: 10.4088/JCP.24m15438.
PMID: 39999772DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marco Pappagallo, MD
- Organization
- Relmada Therapeutics
Study Officials
- STUDY DIRECTOR
Marco Pappagallo, MD
Relmada Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
April 19, 2021
First Posted
April 22, 2021
Study Start
April 1, 2021
Primary Completion
July 27, 2023
Study Completion
July 27, 2023
Last Updated
February 11, 2025
Results First Posted
August 9, 2024
Record last verified: 2023-01