Clinical trial NCT04855760: Safety of REL-1017 for Major Depressive Disorder
Official title: A Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety of REL-1017 as a Treatment of Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: REL-1017
Lead sponsor: Relmada Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-22
Enrollment: 627
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and Tolerability of REL-1017 as Incidence of Treatment Emergent Adverse Events (TEAEs)
timeFrame: 52 weeks
Secondary outcomes:
measure: Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 3
timeFrame: 3 Month
measure: Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 6
timeFrame: 6 Month
measure: Change in the QT Interval With Fridericia's Correction (QTcF) Interval From Baseline to Month 12
timeFrame: 12 Month
measure: Change in Diastolic Blood Pressure From Baseline to Month 3
timeFrame: 3 Month
measure: Change in Diastolic Blood Pressure From Baseline to Month 12
timeFrame: 12 Month
measure: Change in Systolic Blood Pressure From Baseline to Month 3
timeFrame: 3 Month
measure: Change in Systolic Blood Pressure From Baseline to Month 12
timeFrame: 12 Month
measure: Change in Heart Rate From Baseline to Month 3
timeFrame: 3 Month
measure: Change in Heart Rate From Baseline to Month 12
timeFrame: 12 Month
measure: Change in Weight From Baseline to Month 3
timeFrame: 3 Month
measure: Change in Weight From Baseline to Month 12
timeFrame: 12 Month
Other outcomes:
measure: Change in the MADRS10 Total Score From Baseline to Month 3
timeFrame: 3 Month
measure: Change in the MADRS10 Total Score From Baseline to Month 12
timeFrame: 12 Month
Locations:
city: Miami
country: United States
facility: Relmada Site
state: Florida
city: Miami
country: United States
facility: Relmada Site
state: Florida
city: Orlando
country: United States
facility: Relmada Site
state: Florida
city: Palm Bay
country: United States
facility: Relmada Site
state: Florida
city: Chicago
country: United States
facility: Relmada Site
state: Illinois
city: Chicago
country: United States
facility: Relmada Site
state: Illinois
city: Boston
country: United States
facility: Relmada Site
state: Massachusetts
city: Watertown
country: United States
facility: Relmada Site
state: Massachusetts
city: Staten Island
country: United States
facility: Relmada Site
state: New York
Study officials:
affiliation: Relmada Therapeutics
name: Marco Pappagallo, MD
role: STUDY_DIRECTOR
References: