REL-1017 for Psychosis, Involutional

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Relmada Site 103, Wichita Falls, TX
Psychosis, Involutional+3 More
REL-1017 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help treat major depressive disorder.

See full description

Eligible Conditions

  • Psychosis, Involutional
  • Major Depressive Disorder (MDD)

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether REL-1017 will improve 1 primary outcome in patients with Psychosis, Involutional. Measurement will happen over the course of 52 weeks.

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

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Side Effects for

REL-1017 25 mg
Headache
11%
Dyspepsia
11%
Vomiting
5%
Pruritius
5%
Somnolence
5%
Constipation
5%
Urinary Tract Infection
5%
Fatigue
5%
Sedation
5%
Nausea
5%
Palpitations
5%
Flatulence
5%
Dizziness
5%
Pollakiuria
5%
Back Pain
5%
Upper Respiratory Infection
0%
Tremor
0%
Blood Pressure Increases
0%
Presyncope
0%
Feeling of Relaxation
0%
Application Site Erosion
0%
Gastroesophageal Reflux Disease
0%
Diarrhea
0%
Limb Discomfort
0%
Abnormal Dreams
0%
Restlessness
0%
Hypocalcaemia
0%
Weight Decrease
0%
Influenza
0%
Abdominal Discomfort
0%
Drug-Induced Liver Injury
0%
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03051256) in the REL-1017 25 mg ARM group. Side effects include: Headache with 11%, Dyspepsia with 11%, Vomiting with 5%, Pruritius with 5%, Somnolence with 5%.

Trial Design

1 Treatment Group

REL-1017 25 mg
1 of 1
Experimental Treatment

This trial requires 600 total participants across 1 different treatment group

This trial involves a single treatment. REL-1017 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

REL-1017 25 mg
Drug
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
Dextromethadone
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 52 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 52 weeks for reporting.

Closest Location

Relmada Site 103 - Wichita Falls, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

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

Patient Q&A Section

What is psychosis, involutional?

"The onset of psychosis, involutional, is caused by one or more identifiable medical and familial disorders. We think that it is important for the psychiatrist and family psychiatrist to think of any causal links." - Anonymous Online Contributor

Unverified Answer

What are the signs of psychosis, involutional?

"The first and most obvious sign of psychosis is the presence of psychotic symptoms such as delusions and hallucinations. However, psychosis is a symptom of a more complex disease such as schizophrenia." - Anonymous Online Contributor

Unverified Answer

Can psychosis, involutional be cured?

"There have been recent studies suggesting a cure for psychosis; a recent paper reported one case. There is at least some evidence from case reports and from animal studies that involutional illness might be cured. However, it is still a matter of some dispute." - Anonymous Online Contributor

Unverified Answer

What are common treatments for psychosis, involutional?

"In an urgent review of current evidence, it should be noted that all classes of antipsychotic drugs (atypical and typical drugs) have been evaluated as effective for psychotic illness, but there remains an immense gap in the knowledge of how to treat this disabling disorder. This is particularly problematic in patients with multiple co-morbid psychiatric problems." - Anonymous Online Contributor

Unverified Answer

How many people get psychosis, involutional a year in the United States?

"In this 10-year cohort 1.7% experienced psychosis annually. Age, sex, and substance use predicted psychosis with the greatest effect attributed to sex. Most of the effect of substance use may be attributable to alcohol use." - Anonymous Online Contributor

Unverified Answer

What causes psychosis, involutional?

"Physical aging and degenerative processes have been implicated (i.e. aging-related neurodegenerative diseases, dementia-related neurodegenerative diseases, cerebrovascular events, nutritional deficiencies, autoimmune processes, neuroinflammation, and altered brain metabolism), but our data do not support the hypothesis that the pathogenesis of psychosis, involutional is a degenerative process." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of psychosis, involutional?

"It can be concluded that most cases of acute psychotic disorders were idiopathic from a genetic point of view. This finding suggests that a large percentage of new cases of first-episode psychotic disorders are not the result of a primary or secondary genetic pathology." - Anonymous Online Contributor

Unverified Answer

How does rel-1017 work?

"Rel-1017 produced significant effects similar to lithium on GABAA receptors. Further study of GABAA receptor modulation by compounds such as rel-1017 may be useful to understand the mechanisms of their neuroprotective, mood- stabilising, and antidepressant-like effects in clinical settings." - Anonymous Online Contributor

Unverified Answer

Does rel-1017 improve quality of life for those with psychosis, involutional?

"Rel-1017 may be a candidate for future development as a treatment for psychosis, the primary symptoms of which are hallucinations and delusions, which may be linked to problems with mental efficiency. Rel-1017 has a novel mechanism of action, which may account for the unique efficacy observed in clinical trials." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating psychosis, involutional?

"At present, antipsychotic treatment may relieve psychosis for some patients, however, this is not universal. Psychosis is a symptom found in patients with other psychiatric disorders such as schizophrenia or depression. It is unknown whether or not antipsychotic treatment has a role in treating psychosis. Patients that show psychotic symptoms are usually prescribed antidepressants instead of antipsychotic drugs." - Anonymous Online Contributor

Unverified Answer

Does psychosis, involutional run in families?

"The high occurrence of psychotic disorders observed in our family is inconsistent with the prevailing theory of the etiology of the psychotic disorders and suggests that there is a genetic predisposition to certain psychotic disorders. Findings from a recent study also lend further support to a model of biological vulnerability which postulates that psychotic disorders are the result of a dynamic interaction of genetic and environmental risk factors." - Anonymous Online Contributor

Unverified Answer

How serious can psychosis, involutional be?

"There is a serious risk of suicide among elderly individuals with psychosis. The diagnosis of psychosis may be accompanied by a high level of depressive symptoms especially for individuals over 85 years of age. There is a need to identify factors associated with suicide among psychosis patients in order to identify those with the highest risk and so to assess the effectiveness of preventive measures." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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