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REL-1017 for Depression (Reliance III Trial)

Phase 3
Waitlist Available
Research Sponsored by Relmada Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28
Awards & highlights

Reliance III Trial Summary

This study is evaluating whether a new drug can help people with depression.

Eligible Conditions
  • Depression

Reliance III Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the MADRS10 Total Score From Baseline to Day 28
Secondary outcome measures
MADRS10 Remission Rate (Total Score ≤10) at Day 28
MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28

Side effects data

From 2022 Phase 3 trial • 227 Patients • NCT04688164
12%
Headache
7%
Upper respiratory tract infection
7%
Nausea
6%
Dizziness
5%
COVID-19
4%
Diarrhoea
3%
Constipation
2%
Suicidal Ideation
1%
Cholecystitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
REL-1017 25 mg

Reliance III Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: REL-1017Experimental Treatment1 Intervention
A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017.
Group II: PlaceboPlacebo Group1 Intervention
Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
REL-1017
2021
Completed Phase 3
~1220

Find a Location

Who is running the clinical trial?

Relmada Therapeutics, Inc.Lead Sponsor
8 Previous Clinical Trials
1,682 Total Patients Enrolled
6 Trials studying Depression
1,616 Patients Enrolled for Depression
Marco Pappagallo, MDStudy DirectorRelmada Therapeutics
7 Previous Clinical Trials
1,366 Total Patients Enrolled
3 Trials studying Depression
1,254 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Nevada
Texas
Illinois
How old are they?
18 - 65
65+
What site did they apply to?
Relmada Site 107
Relmada Site 204
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)
2021. "A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05081167.
~61 spots leftby Apr 2025
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