Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-17

Study Completion Date

2024-12-19

Brief Summary

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A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD).

Detailed Description

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This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as an adjunctive treatment of Major Depressive Disorder in patients with inadequate response to ongoing background antidepressant treatment. Eligible patients will continue to take their background antidepressant therapy and be randomized in a 1:1 ratio to treatment with REL-1017 or placebo for a 4 week treatment period.

Conditions

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Major Depressive Disorder Depression

Keywords

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REL-1017 esmethadone Relmada antidepressant adjunctive NMDA receptor antagonist Relight Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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REL-1017 25 mg

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 Type EXPERIMENTAL

REL-1017

Intervention Type DRUG

REL-1017 tablet

Placebo

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)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet

Interventions

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REL-1017

REL-1017 tablet

Intervention Type DRUG

Placebo

Placebo tablet

Intervention Type DRUG

Other Intervention Names

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esmethadone

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) between 18.0 and 35.0 kg/m2.
* Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
* Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE.

Exclusion Criteria

* Psychiatric hospitalization during the current major depressive episode.
* History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant.
* Participants who, in the Investigator's judgment, are at significant risk for suicide.
* Pregnant or planning to become pregnant.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Greene, PhD

Role: STUDY_DIRECTOR

Relmada Therapeutics

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REL-1017-304

Identifier Type: -

Identifier Source: org_study_id

Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

REL-1017 25 mg

REL-1017

Placebo

Placebo

Interventions

REL-1017

Placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Levomecor Inc.

Responsible Party

Principal Investigators

Paul Greene, PhD

Locations

Relmada Site

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Countries

Related Links

Other Identifiers

REL-1017-304