What side effects are associated with this type of intervention?

Common treatments for depression include SSRIs, SNRIs, tricyclic antidepressants, and NMDA receptor antagonists like ketamine. SSRIs and SNRIs can cause side effects such as nausea, insomnia, sexual dysfunction, and increased anxiety. Tricyclic antidepressants may lead to dry mouth, constipation, urinary retention, and cardiac issues. NMDA receptor antagonists, such as ketamine, are associated with side effects like dizziness, dissociation, increased blood pressure, and potential for abuse. It is important to discuss these with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for depression, including selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and atypical antidepressants. Recently, there has been interest in NMDA receptor antagonists for treatment-resistant depression. Esketamine, an NMDA receptor antagonist, was approved by the FDA in 2019 for treatment-resistant depression, marking a significant advancement in this category. Other traditional treatments include tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs), though these are less commonly used due to side effects.

What other types of research exist?

Promising novel alternatives to REL-1017 for depression treatment in 2024 include: 1) MK-0657, an NR2B antagonist, which has shown potential antidepressant properties in treatment-resistant depression (TRD) patients. 2) Triple reuptake inhibitors, which target serotonin, norepinephrine, and dopamine reuptake, offering a broader spectrum of action. 3) mGluR2/3 antagonists like LY341495, which have demonstrated rapid and long-lasting antidepressant effects in preclinical models.

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REL-1017 for Depression (RELIGHT 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

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

Be older than 18 years old

Must not have

Were you hospitalized during your most recent depressive episode?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 28

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of REL-1017 aren't detailed here but typically could include nausea, headache, dizziness, and sleep disturbances among others common in psychiatric medications.

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 ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in MADRS Total Score From Baseline to Day 28

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 / 2Eligibility 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 include selective serotonin reuptake inhibitors (SSRIs), which increase serotonin levels in the brain, and serotonin-norepinephrine reuptake inhibitors (SNRIs), which boost both serotonin and norepinephrine. Tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs) also work by altering neurotransmitter levels but are less commonly used due to side effects. NMDA receptor antagonists, such as ketamine and the investigational drug REL-1017, represent a novel approach by targeting glutamate signaling, which can rapidly alleviate depressive symptoms. This is particularly important for treatment-resistant depression, offering hope for patients who do not respond to traditional therapies.

Targeting glutamate signalling in depression: progress and prospects.Ketamine: promising path or false prophecy in the development of novel therapeutics for mood disorders?