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Completed

NCT Number: NCT04855760

Safety of REL-1017 for Major Depressive Disorder

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Relmada Site, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

REL-1017

Drug

REL-1017 tablet

Other names: Esmethadone HCl

Primary outcomes

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

    Time frame: 52 weeks

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

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  4. Change in Diastolic Blood Pressure From Baseline to Month 3

    Time frame: 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.

  5. Change in Diastolic Blood Pressure From Baseline to Month 12

    Time frame: 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.

  6. Change in Systolic Blood Pressure From Baseline to Month 3

    Time frame: 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.

  7. Change in Systolic Blood Pressure From Baseline to Month 12

    Time frame: 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.

  8. Change in Heart Rate From Baseline to Month 3

    Time frame: 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.

  9. Change in Heart Rate From Baseline to Month 12

    Time frame: 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.

  10. Change in Weight From Baseline to Month 3

    Time frame: 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.

  11. Change in Weight From Baseline to Month 12

    Time frame: 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.

Other outcomes

  1. Change in the MADRS10 Total Score From Baseline to Month 3

    Time frame: 3 Month

    Therapeutic efficacy of REL-1017 in the Montgomery-Asberg Depression Rating Scale (MADRS10) A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression.

    A negative change from baseline indicates improvement.

  2. Change in the MADRS10 Total Score From Baseline to Month 12

    Time frame: 12 Month

    Therapeutic efficacy of REL-1017 in the Montgomery-Asberg Depression Rating Scale (MADRS10) A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression.

    A negative change from baseline indicates improvement.

Sponsors and collaborators

Lead sponsor

Relmada Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety of REL-1017 as a Treatment of Major Depressive Disorder

Acronym: RELIANCE-OLS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 22, 2021
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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