REL-1017 for Melancholia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Relmada Site 235, Staten Island, NY
Melancholia+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

  • Melancholia
  • Major Depressive Disorder (MDD)

Treatment Effectiveness

Effectiveness Progress

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

Other trials for Melancholia

Study Objectives

This trial is evaluating whether REL-1017 will improve 2 secondary outcomes in patients with Melancholia. Measurement will happen over the course of Day 7.

Day 28
Change in CGI-S score
Day 7
Change in the MADRS10 total score

Trial Safety

Safety Progress

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

Other trials for Melancholia

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

2 Treatment Groups

REL-1017 25 mg
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 400 total participants across 2 different treatment groups

This trial involves 2 different treatments. REL-1017 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

REL-1017 25 mg
Drug
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)
Placebo
Drug
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).
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: day 28
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 28 for reporting.

Closest Location

Relmada Site 235 - Staten Island, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
from different classes The person has been treated with approved, stable first-line anti-depressant therapy, but has had an inadequate response to 1 to 3 courses of treatment with an antidepressant medication from different classes. show original
The author is discussing their current experience with major depression. show original
Adults 18 to 65 years, inclusive.
MDD is a mood disorder that causes a persistently low mood and a loss of interest or pleasure in activities. show original

Patient Q&A Section

What are common treatments for psychosis, involutional?

"Involutional psychosis is largely treated by conventional medicine and sometimes assisted by psychotherapy; CBT is not recommended but may be used in the absence of adequate supportive care. There is no consensus on the specific treatments of delusions or hallucinations or on the usefulness of antipsychotic or antidepressant medications. The provision of psychoeducational interventions and a range of short-term and long-term care options has been developed for psychiatric inpatients." - Anonymous Online Contributor

Unverified Answer

What are the signs of psychosis, involutional?

"Results from a recent paper suggest that the most typical symptoms of psychosis that occur during involuntary hospitalization might be in the absence of recent symptoms of schizophrenia or major depression (i.e., involutional psychosis)." - Anonymous Online Contributor

Unverified Answer

Can psychosis, involutional be cured?

"Involutional psychosis, at the minimum, cannot be cured. Results from a recent clinical trial did not confirm the earlier observational evidence that involutional psychosis progresses towards a less extreme form of psychosis." - Anonymous Online Contributor

Unverified Answer

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

"Approximately 4 million people in the United States will develop an episode of psychosis. The proportion of this population living in rural areas is higher than the overall U.S. population. As a result, a much larger proportion of people living in rural areas develop psychosis than in urban areas. A further 2.7 million people will be diagnosed with an episode of dementia." - Anonymous Online Contributor

Unverified Answer

What is psychosis, involutional?

"The changes occurring as a result of brain aging seem to be the main cause of the emergence of psychosis, and the presence/absence of specific genetic factors. The onset is correlated with the presence of involutional changes." - Anonymous Online Contributor

Unverified Answer

What causes psychosis, involutional?

"This is the first meta-analysis of the association between psychosis and involution and the first meta-analysis of the effects of involution on personality. Overall, involution is associated with increased personality disorders, as well as psychotic manifestations." - Anonymous Online Contributor

Unverified Answer

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

"Rel-1017 had a statistically significant positive effect on quality of life for those treated for psychosis. This effect was predominantly seen in psychotic symptoms related to insight. Recent findings are in line with the findings of previous studies and suggest that Rel-1017 has the potential to improve quality of life of patients suffering from severe mental illness." - Anonymous Online Contributor

Unverified Answer

Has rel-1017 proven to be more effective than a placebo?

"Rel1017 is effective for the adjunctive treatment of psychosis without causing significant weight gain. It was found to be more effective and safe compared to a placebo in a large randomized, placebo-controlled, single-center study. Rel1017 warrants further trials to ensure general usage." - Anonymous Online Contributor

Unverified Answer

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

"There is a need for more randomized controlled trials on both sides of current antipsychotic treatment, with the ultimate goal of a more robust evidence base so that psychotic illnesses such as schizophrenia and psychotic disorders can obtain better pharmacodynamic and/or serotonergic modulation of the human brain neurotransmitters which play a huge role in schizophrenia." - Anonymous Online Contributor

Unverified Answer

How serious can psychosis, involutional be?

"In this series the first psychotic event was experienced as acute, non-stressful, lasting for a few hours, and most people are able to live with psychosis well, despite some deficits in terms of self-care. By contrast, the second psychotic episode was a significant, chronic, and disabling experience for many people, with the associated deficits far more profound than those for any earlier episode. A third event is an extreme rarity, with a particularly poor prognosis. It is important to note that these are mainly non-affective psychosis, but depressive psychosis was also experienced by some people." - Anonymous Online Contributor

Unverified Answer

How does rel-1017 work?

"Because rel-1017 shows antipsychotic-like properties, future studies are necessary to study possible interactions with other antipsychotics and to discover if rel-1017 will benefit from combined exposure with antipsychotics at conventional doses and lower doses." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving rel-1017?

"Recent findings of the trial in which patients had shown a statistically significant improvement in their clinical status and quality of life and in a subsequent randomized study with a placebo control, confirm the efficacy of treatment with ROI-1017 for ALS and the safety of this compound for the treatment of ALS in patients presenting with the progressive disease. ROI-1017 is currently in clinical development as a compound for ALS." - 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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