REL-1017 for Psychosis, Involutional

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Psychosis, Involutional+3 More
REL-1017 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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
  • Psychosis, Involutional
  • Major Depressive Disorder (MDD)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Psychosis, Involutional

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 52 weeks

52 weeks
Safety and tolerability of REL-1017 as incidence of treatment emergent adverse events (TEAEs)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Psychosis, Involutional

Side Effects for

REL-1017 25 mg
11%Dyspepsia
11%Headache
5%Vomiting
5%Fatigue
5%Somnolence
5%Sedation
5%Urinary Tract Infection
5%Pruritius
5%Constipation
5%Nausea
5%Palpitations
5%Flatulence
5%Dizziness
5%Pollakiuria
5%Back Pain
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03051256) in the REL-1017 25 mg ARM group. Side effects include: Dyspepsia with 11%, Headache with 11%, Vomiting with 5%, Fatigue with 5%, Somnolence with 5%.

Trial Design

1 Treatment Group

REL-1017 25 mg
1 of 1
Experimental Treatment

600 Total Participants · 1 Treatment Group

Primary Treatment: REL-1017 · No Placebo Group · Phase 3

REL-1017 25 mg
Drug
Experimental Group · 1 Intervention: REL-1017 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dextromethadone
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 52 weeks

Who is running the clinical trial?

Relmada Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
992 Total Patients Enrolled
Marco Pappagallo, MDStudy DirectorRelmada Therapeutics
7 Previous Clinical Trials
976 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Adults aged between 18 and 65 years.
The patient was diagnosed with Major Depressive Disorder (MDD) after a Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
The person is currently experiencing a major depressive episode.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: October 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Arkansas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Relmada Site 147100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%
Most responsive sites:
  1. Relmada Site 147: < 48 hours
Average response time
  • < 2 Days