← Back to Search

Melatonin Receptor Agonist

oral melatonin tablets (NatureMade brand) for Sleep

N/A
Waitlist Available
Led By Raquel Gur, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subthreshold psychosis-risk positive symptoms (e.g. hallucinations or unusual beliefs) on the Structured Interview of Psychosis-Risk Syndromes (SIPS)
At least mild sleep disturbances on the SIPS (>=1 on the SIPS sleep item (G1)) with difficulties with
Must not have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upchange in actigraph-measured m10 from melatonin randomization day (day 0) to day 14
Awards & highlights

Study Summary

This trial looks at whether melatonin supplements can help reduce symptoms in youths who are at risk for or have psychosis.

Eligible Conditions
  • Sleep
  • Psychosis

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have trouble falling asleep, staying asleep, or keeping a regular sleep routine.
Select...
You have a good level of intelligence with an IQ score above 70.
Select...
You are in good overall health.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in actigraph-measured m10 from melatonin randomization day (day 0) to day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in actigraph-measured m10 from melatonin randomization day (day 0) to day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Actigraph-measured sleep (increased total sleep time)
Secondary outcome measures
Improved self-reported sleep
Other outcome measures
Decreased actigraph-measured sleep latency
Increased actigraph-measured sleep efficiency
Increased activity (M10)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MelatoninExperimental Treatment1 Intervention
Subjects will receive oral melatonin tablets 2.5-10mg nightly for 2 weeks. All will receive melatonin 5mg for one week, then at the 1 week visit, the dose can be continued at 5mg or adjusted to 2.5mg or 10mg nightly based on clinical assessment of patient response and side effects.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will receive pill placebo nightly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
oral melatonin tablets (NatureMade brand)
2019
N/A
~30

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
687 Previous Clinical Trials
8,567,901 Total Patients Enrolled
5 Trials studying Sleep
299 Patients Enrolled for Sleep
University of PennsylvaniaOTHER
1,962 Previous Clinical Trials
42,526,516 Total Patients Enrolled
6 Trials studying Sleep
3,769 Patients Enrolled for Sleep
Brain and Behavior Research Foundation (NARSAD Young Investigator Award, Grant Number 26742)UNKNOWN

Frequently Asked Questions

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

How many individuals are enrolled in this experiment?

"Yes, clinicaltrials.gov confirms that the trial is actively recruiting for 40 participants from 1 site. The medical study was first listed on January 18th 2019 and recently updated on March 10th 2022."

Answered by AI

Is there a way for me to take part in this medical experiment?

"This trial is enrolling 40 individuals between 11 and 30 years of age who present with subthreshold psychotic symptoms, moderate to severe sleep disturbances, an IQ greater than 70, no concurrent pregnancy or breastfeeding status, a willingness to report changes in medications or therapies during the study as well as use reliable birth control where applicable. Participants must be patients at Children's Hospital of Philadelphia (CHOP), University of Pennsylvaniaent pregnancy or breastfeeding status, a willingness to report changes in medications or therapies during the study as well as use reliable birth control where applicable. Participants must be patients at Children's Hospital of Philadelphia (CHOP), University of Pennsylvania (UPenn) or members of their surrounding communities."

Answered by AI

Is this a groundbreaking clinical trial?

"At present, there are 24 ongoing studies of NatureMade brand oral melatonin tablets happening in 12 cities and 9 countries. This research was first initiated by Eli Lilly and Company back in 2007 with 20 test subjects, ultimately achieving the necessary approval phase. Since then, 18 414 related trials have been completed."

Answered by AI

Are there any vacancies remaining in this clinical trial?

"Affirmative. Per the details on clinicaltrials.gov, this experiment is presently enrolling participants and was originally announced in January 18th 2019 with a most recent edit made March 10th 2022. 40 individuals are being welcomed at 1 medical site."

Answered by AI

Does this trial accept participants who are 50 or more years of age?

"Eligibility for this trial necessitates that patients are between 11 and 30 years of age."

Answered by AI

What prior investigations have been conducted into NatureMade melatonin tablets?

"Currently, 24 trials are assessing the efficacy of oral melatonin tablets (NatureMade brand) with 4 reaching Phase 3. Most tests for this product occur in Houston, Texas; however, it is being administered across 25 sites globally."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Melatonin Effects on Sleep and Circadian Rhythm in Youth and Young Adults With At-risk Symptoms
2019. "Melatonin Effects on Sleep and Circadian Rhythm in Youth and Young Adults With At-risk Symptoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03826563.
~4 spots leftby Nov 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top