Safety of REL-1017 for Major Depressive Disorder

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: REL-1017

• Registration Number: NCT04855760
• Lead Sponsor: Relmada Therapeutics, Inc.

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.

Detailed Description

This was a multicenter, open-label, long-term study of REL-1017 to evaluate the long-term safety and long-term durability of response in patients with MDD. Patients who completed previous randomized, double-blind Phase 3 trials (NCT04688164, NCT04855747, NCT05081167) of REL-1017 as adjunctive therapy or monotherapy for MDD were asked to continue treatment with REL-1017 25 mg daily for up to 1 year. De novo patients who satisfied inclusion/exclusion criteria also were enrolled and received a 75 mg loading dose of REL-1017 on Day 1 followed by a maintenance dose of 25 mg REL-1017 daily for the remainder of the study (Days 2-365). When REL-1017 was administered as adjunctive treatment, patients continued to use a stable dosage of their concomitant antidepressants.

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-22
• Status Verified: 2023-01
• Primary Completion: 2023-07-27
• Study Completion: 2023-07-27
• Results First Submitted: 2024-07-16
• Results First Submitted QC: 2024-07-16
• Last Update Submitted: 2024-07-16
• Results First Posted: 2024-08-09
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 627

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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
REL-1017	REL-1017	Roll-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.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of REL-1017 as Incidence of Treatment Emergent Adverse Events (TEAEs)	52 weeks	Subjects with at least one Treatment Emergent Adverse Events (TEAEs)

Secondary Outcome Measures

Name	Time	Method
Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 3	3 Month	Cardiac Safety of REL-1017 as measured by the Change in the QT interval with Fridericia's correction (QTcF) Interval From Baseline to Month 3.; A negative change from baseline indicates shortening of the QTcF.
Change in Diastolic Blood Pressure From Baseline to Month 3	3 Month	Cardiac Safety of REL-1017 as measured by the Diastolic Blood Pressure (Supine/Semi-Supine) From Baseline to Month 3.; A negative change from baseline indicates a reduction in Diastolic Blood Pressure.
Change in Weight From Baseline to Month 3	3 Month	Overall Safety of REL-1017 as measured by Weight From Baseline to Month 3.; A negative change from baseline indicates a reduction in Weight.
Change in Weight From Baseline to Month 12	12 Month	Overall Safety of REL-1017 as measured by Weight From Baseline to Month 12.; A negative change from baseline indicates a reduction in Weight.
Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 6	6 Month	Cardiac Safety of REL-1017 as measured by the Change in the QT interval with Fridericia's correction (QTcF) Interval From Baseline to Month 6.; A negative change from baseline indicates shortening of the QTcF.
Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 12	12 Month	Cardiac Safety of REL-1017 as measured by the Change in the QT interval with Fridericia's correction (QTcF) Interval From Baseline to Month 12.; A negative change from baseline indicates shortening of the QTcF.
Change in Systolic Blood Pressure From Baseline to Month 3	3 Month	Cardiac Safety of REL-1017 as measured by the Systolic Blood Pressure (Supine/Semi-Supine) From Baseline to Month 3.; A negative change from baseline indicates a reduction in Systolic Blood Pressure.
Change in Systolic Blood Pressure From Baseline to Month 12	12 Month	Cardiac Safety of REL-1017 as measured by the Systolic Blood Pressure (Supine/Semi-Supine) From Baseline to Month 12.; A negative change from baseline indicates a reduction in Systolic Blood Pressure.
Change in Heart Rate From Baseline to Month 3	3 Month	Cardiac Safety of REL-1017 as measured by the Heart Rate (Supine/Semi-Supine) From Baseline to Month 3.; A negative change from baseline indicates a reduction in Heart Rate.
Change in Heart Rate From Baseline to Month 12	12 Month	Cardiac Safety of REL-1017 as measured by the Heart Rate (Supine/Semi-Supine) From Baseline to Month 12.; A negative change from baseline indicates a reduction in Heart Rate.
Change in Diastolic Blood Pressure From Baseline to Month 12	12 Month	Cardiac Safety of REL-1017 as measured by the Diastolic Blood Pressure (Supine/Semi-Supine) From Baseline to Month 12.; A negative change from baseline indicates a reduction in Diastolic Blood Pressure.

Trial Locations

Locations (1)

Relmada Site; 🇺🇸 Staten Island, New York, United States