REL-1017 for Depression

(RELIANCE-II Trial)

Recruiting at 109 trial locations

Overseen By Senior Vice President

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Relmada Therapeutics, Inc.

Must be taking: Antidepressants

Must not be taking: Ketamine, Esketamine

Disqualifiers: Bipolar, Psychosis, Mania, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

236 Participants Needed

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.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current antidepressant medications. Participants will continue their current antidepressant therapy along with the study drug or placebo.

How is the drug REL-1017 different from other depression treatments?

REL-1017, also known as JO 1017, is unique because it selectively inhibits serotonin uptake without affecting other brain receptors, making it potentially safer with fewer side effects compared to traditional antidepressants. Unlike many antidepressants, it does not cause severe heart-related side effects and lacks central anticholinergic or antihistaminic properties. ^{1 2 3 4 5}

Research Team

Paul Greene, PhD

Principal Investigator

Relmada Therapeutics

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 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?

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive REL-1017 or placebo once daily for 28 days as an adjunctive treatment to their current antidepressant therapy

4 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• REL-1017

Trial Overview 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.

Participant Groups

Group I: REL-1017 25 mg Experimental Treatment 1 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: Placebo Placebo Group 1 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).

Who Is Running the Clinical Trial?

Relmada Therapeutics, Inc.

Lead Sponsor

Trials

9

Recruited

1,500+

References

1. Canada pubmed.ncbi.nlm.nih.gov

Reboxetine: a preliminary report on its use through the Special Access Program. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Reboxetine: a selective norepinephrine reuptake inhibitor for the treatment of depression. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Biochemical and pharmacological evaluation of the novel antidepressant and serotonin uptake inhibitor 2-(3,4-Dichlorobenzyl)-2-dimethylamino-1-propanol hydrochloride. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Reboxetine addition in patients with mirtazapine-resistant depression: a case series. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Novel antagonists of 5-HT6 and/or 5-HT7 receptors affect the brain monoamines metabolism and enhance the anti-immobility activity of different antidepressants in rats. [2019]