What side effects are associated with this type of intervention?

Common treatments for depression, such as SSRIs (e.g., fluoxetine, sertraline) and SNRIs (e.g., venlafaxine), often have side effects including nausea, insomnia, dizziness, dry mouth, and sexual dysfunction. Adjunctive therapies like psychotherapy generally have fewer physical side effects but may cause emotional discomfort as patients confront difficult issues. Light therapy can cause eye strain, headache, and nausea. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs and tolerances.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Major Depressive Disorder (MDD), including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine, and atypical antidepressants like bupropion and mirtazapine. For patients who do not fully respond to monotherapy, adjunctive treatments are often employed. These can include the addition of another antidepressant, atypical antipsychotics like aripiprazole, or mood stabilizers such as lamotrigine. The study of REL-1017 as an adjunctive treatment for MDD fits within this context of seeking effective combination therapies to enhance treatment outcomes for patients with treatment-resistant depression.

What other types of research exist?

Promising novel alternatives to REL-1017 for adjunctive treatment of Major Depressive Disorder include Lu AA21004 (Vortioxetine), which has shown efficacy and safety in multiple randomized, double-blind, placebo-controlled trials. Additionally, L-methylfolate calcium 15 mg as adjunctive therapy with SSRIs has demonstrated sustained remission and recovery in patients who fail to respond to antidepressant monotherapy.

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REL-1017 for Depression (RELIANCE-II Trial)

Verified Trial

Phase 3

Recruiting

Research Sponsored by Relmada Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

You have been diagnosed with Major Depressive Disorder

Are you between 18-65 years old?

Must not have

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 30 days

Treatment Varies

Follow Up 1 day

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of REL-1017 aren't listed here, common side effects of similar medications may include dizziness, nausea, headache, sleep disturbances or changes in appetite. Each person's reaction can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 30 days0 visits

Treatment ~ Varies

Follow Up ~ 1 day0 visits

Screening ~ 30 days

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 30 days for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Change in CGI-S score

Change in the MADRS10 total score

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

Pivotal Trial

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

Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

REL-1017

2021

Completed Phase 3

~1220

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression, such as SSRIs, SNRIs, TCAs, and MAOIs, work by altering levels of neurotransmitters like serotonin, norepinephrine, and dopamine in the brain, which are crucial for mood regulation. REL-1017, an adjunctive treatment under study, likely enhances these effects, providing additional symptom relief. Understanding these mechanisms helps in tailoring treatment plans to individual neurochemical needs, improving efficacy and patient outcomes.

Bulimia nervosa : a review of therapy research.