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REL-1017 for Depression (RELIANCE-OLS Trial)

Phase 3

Waitlist Available

Research Sponsored by Relmada Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing the safety of adding a new drug, REL-1017, to the current treatment of people with Major Depressive Disorder. Participants will continue their usual antidepressants while taking REL-1017 daily for an extended period. REL-1017 (esmethadone) has shown rapid and sustained antidepressant effects in previous trials.

Eligible Conditions

Depression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change in Diastolic Blood Pressure From Baseline to Month 12

Change in Diastolic Blood Pressure From Baseline to Month 3

Change in Heart Rate From Baseline to Month 12

+8 more

Other study objectives

Change in the MADRS10 Total Score From Baseline to Month 12

Change in the MADRS10 Total Score From Baseline to Month 3

Side effects data

From 2022 Phase 3 trial • 227 Patients • NCT04688164

12%

Headache

Upper respiratory tract infection

Nausea

Dizziness

COVID-19

Diarrhoea

Constipation

Suicidal Ideation

Cholecystitis

100%

80%

60%

40%

20%

Study treatment Arm

REL-1017 25 mg

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: REL-1017Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

REL-1017

2021

Completed Phase 3

~1220

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