Safety of REL-1017 for Major Depressive Disorder

Relmada Therapeutics, Inc.627 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

627

Conditions

Major Depressive Disorder

Interventions

REL-1017DRUG

REL-1017 tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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. * 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.

Locations (9)

Relmada Site

Miami, Florida, United States

Relmada Site

Miami, Florida, United States

Relmada Site

Orlando, Florida, United States

Relmada Site

Palm Bay, Florida, United States

Outcomes

Primary Outcomes

Safety and Tolerability of REL-1017 as Incidence of Treatment Emergent Adverse Events (TEAEs)

Subjects with at least one Treatment Emergent Adverse Events (TEAEs)

Time frame: 52 weeks

Secondary Outcomes

Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 3

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.

Time frame: 3 Month

Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 6

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.

Time frame: 6 Month

Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 12

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.

Time frame: 12 Month

Change in Diastolic Blood Pressure From Baseline to Month 3

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.

Time frame: 3 Month

Change in Diastolic Blood Pressure From Baseline to Month 12

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.

Data from ClinicalTrials.gov

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