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REL-1017 for Depression (RELIANCE-OLS 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 52 weeks
Awards & highlights

RELIANCE-OLS Trial Summary

This trial will study the safety of REL-1017 as a treatment for Major Depressive Disorder when taken in addition to current antidepressant therapy.

Eligible Conditions
  • Depression

RELIANCE-OLS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of REL-1017 as incidence of treatment emergent adverse events (TEAEs)

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-OLS Trial Design

1Treatment groups
Experimental Treatment
Group I: REL-1017 25 mgExperimental Treatment1 Intervention
Participants will take 1 tablet of REL-1017 25 mg, 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

Find a Location

Who is running the clinical trial?

Relmada Therapeutics, Inc.Lead Sponsor
8 Previous Clinical Trials
1,287 Total Patients Enrolled
6 Trials studying Depression
1,221 Patients Enrolled for Depression
Marco Pappagallo, MDStudy DirectorRelmada Therapeutics
7 Previous Clinical Trials
971 Total Patients Enrolled
3 Trials studying Depression
859 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.

Is there a lack of adverse effects for people who take REL-1017?

"There is some evidence, from both efficacy and safety data, to support the use of REL-1017. Consequently, our team has given it a safety score of 3."

Answered by AI

If a patient is younger than 40, can they still participate in the research?

"The age range for participants in this trial are individuals that are both older than 18 and younger than 65."

Answered by AI

Is this the first time REL-1017 has been trialed?

"Currently, there are 3 ongoing clinical trials for REL-1017. 2 of these trials have reached Phase 3. The many studies being conducted for REL-1017 originated in Saraland, Alabama; however, there are now 153 locations worldwide where research is being conducted."

Answered by AI

How many study participants will be taking part in this research?

"That is correct. The trial was posted on April 1st, 2021 and is actively recruiting patients. The trial is looking for 600 patients from 100 different locations."

Answered by AI

In how many different medical establishments is this investigation being conducted today?

"There are a total of 100 locations where this trial is being offered, such as Relmada Site 241 in Baytown, Relmada Site 150 in Columbus, and Relmada Site 242 in Waukesha."

Answered by AI

To your knowledge, is this research the first to study this topic?

"As of now, there are 3 ongoing clinical trials for REL-1017 across 95 locations in 3 different nations. The first trial began in 2021. That trial, which was sponsored by Relmada Therapeutics, Inc., included 400 patients and concluded its Phase 3 stage of drug approval. In the years since 2021, 6 more studies have completed."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
Florida
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Relmada Site 116
Relmada Site 114
Relmada Site 124
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
2
3+

Why did patients apply to this trial?

Depression is getting worse. I have tried everything and I am tired. Relief from my depression need the money.
PatientReceived no prior treatments
I still have severe bouts of depression and Anxiety. I have very bad,depression and I need the help asap.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Is this a paid trial? How long is the trial? How long will the trial last?
PatientReceived no prior treatments
Is there any compensation, how long is the trial? I was asked if I would be willing to travel, will I be reimbursed if I travel?
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Relmada Site 147: < 48 hours
  2. Relmada Site 122: < 48 hours
  3. Relmada Site 150: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
Email
Recent research and studies
clinicaltrials.govStudy
Safety of REL-1017 for Major Depressive Disorder
2021. "Safety of REL-1017 for Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04855760.
~157 spots leftby Apr 2025
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