REL-1017 for Depression

(RELIGHT Trial)

Recruiting at 1 trial location

Overseen By Senior Vice President

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Relmada Therapeutics, Inc.

Disqualifiers: Psychiatric hospitalization, Significant health conditions, Suicide risk, Pregnancy, others

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: 4

Duration: 4 weeks

27 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests REL-1017, a new drug, in people with major depression who aren't getting better with their current medication. The drug is taken regularly alongside their usual antidepressant to see if it helps improve their symptoms. REL-1017 has shown favorable safety, tolerability, and potential rapid and sustained antidepressant effects in previous trials.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial organizers or your doctor for guidance.

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

REL-1017 is unique because it is a selective serotonin uptake inhibitor that does not have the severe side effects often associated with other antidepressants, such as cardiotoxicity or central anticholinergic effects. It also has a high safety margin and may be useful for other conditions involving serotonin, like anxiety and panic attacks. ^{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 haven't had enough improvement from 1 to 3 antidepressant treatments. They must not be hospitalized for MDD currently, pregnant, or at high risk of suicide as judged by the investigator.

Inclusion Criteria

Male or female outpatients, 18-65 years of age, inclusive

Have you tried more than 1 but not more than 3 treatments for your depression that have not worked?

Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE

Exclusion Criteria

Were you hospitalized during your most recent depressive episode?

Pregnant or planning to become pregnant

I have been hospitalized for depression recently.

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 4 weeks as an adjunctive treatment to their ongoing antidepressant therapy

4 weeks

4 visits (in-person)

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 against a placebo in people with MDD. Participants are randomly assigned to either get the real drug or a fake one without knowing which they're getting, to fairly measure the drug's effects.

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. 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]

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

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

3. 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]

4. Canada pubmed.ncbi.nlm.nih.gov

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

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

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