REL-1017 for Depression (RELIANCE-II Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Verified Trial

Recruiting

Sponsor: Relmada Therapeutics, Inc.

Stay on your current meds

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests if adding REL-1017 to current antidepressant treatments can better help people with Major Depressive Disorder. Participants will take their usual antidepressants plus either REL-1017 or another substance. The goal is to see if REL-1017 can improve their depression symptoms. REL-1017 (esmethadone) has shown potential rapid and sustained antidepressant effects in previous trials.

Eligibility Criteria

This trial is for adults aged 18-65 with Major Depressive Disorder (MDD) who are currently experiencing a depressive episode and haven't had adequate relief from 1 to 3 antidepressant treatments. Participants must be on stable first-line antidepressant therapy. It's not for those with severe substance abuse, recent opioid use, history of certain brain stimulation therapies, suicidal behavior in the past year, bipolar disorder, psychosis or prior NMDAR antagonist treatment.

Inclusion Criteria

You have been diagnosed with Major Depressive Disorder

Are you between 18-65 years old?

Are you currently depressed?

Have previous depression medications not worked for you?

Exclusion Criteria

Have you been diagnosed with a mental illness other than depression?

Have you taken ketamine or esketamine for your depression in the past?

Treatment Details

The study tests REL-1017 as an add-on treatment for MDD against a placebo. Participants will continue their regular antidepressants and receive either REL-1017 or a placebo daily. The trial aims to see if adding REL-1017 improves depression symptoms more than just the standard treatment alone.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: REL-1017 25 mgExperimental Treatment1 Intervention

During the double blind treatment period (28 days), participants will take 1 tablet of REL-1017 25 mg, orally, per day in addition to their ongoing antidepressant (ADT)

Group II: PlaceboPlacebo Group1 Intervention

During the double blind treatment period (28 days), participants will take 1 tablet of placebo, orally, per day in addition to their ongoing antidepressant (ADT).