Melatonin Effects on Sleep and Circadian Rhythm in Youth and Young Adults With At-risk Symptoms
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|ClinicalTrials.gov Identifier: NCT03826563|
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : January 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Psychosis Sleep||Drug: oral melatonin tablets (NatureMade brand) Other: Placebo||Not Applicable|
Context: Sleep disturbances and circadian dysrhythmias have been associated with psychotic symptom severity in Psychosis Spectrum (PS) youths. Supplemental melatonin is a safe over-the-counter dietary supplement, and several studies have found that melatonin improves sleep across several childhood neuropsychiatric disorders.
Objectives: Investigators seeks to determine whether supplemental melatonin improves sleep and circadian alignment in PS youth. Investigators will also investigate whether supplemental melatonin affects psychotic symptoms, neurocognition, and peripheral inflammatory and oxidative stress markers.
Study Design: Parallel group, double-blind, randomized, placebo-controlled trial Setting/Participants: 40 PS youths ages 11-30 years old (throughout the protocol we use "youth" to describe this age group) with sleep disturbances will be recruited from an extant cohort of PS youths followed by our lab in the Philadelphia Neurodevelopmental Cohort (PNC), Children's Hospital of Philadelphia (CHOP), University of Pennsylvania (UPenn), and the surrounding community. The study will be conducted at CHOP and UPenn.
Study Interventions and Measures: Youths will be randomized to receive pill placebo or oral melatonin. Participants will take melatonin (or placebo) at the same time every evening for 2 weeks (final dose range 2.5-10 mg nightly). Outcomes will be assessed at 1 week, 2 weeks, and 6-months. Primary outcomes will be changes in self-reported sleep and actigraph-measured sleep and circadian rhythm. Secondary outcomes will be psychotic symptoms, neurocognition, and peripheral blood markers of inflammation and oxidative stress.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Only the pharmacy will know the randomization arms.|
|Official Title:||Melatonin Effects on Sleep and Circadian Rhythm in Youth and Young Adults With At-risk Symptoms|
|Actual Study Start Date :||January 18, 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 1, 2023|
Placebo Comparator: Placebo
Subjects will receive pill placebo nightly
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.
Drug: oral melatonin tablets (NatureMade brand)
- Actigraph-measured sleep (increased total sleep time) [ Time Frame: Change in total sleep time from melatonin randomization day (Day 0) to Day 14 ]Actigraph-measured total sleep time will be used to assess actigraph-measured sleep efficacy, Actigraphs from the Actigraph Company will be used to analyze the data using Actilife software.
- Improved self-reported sleep [ Time Frame: Change in total PSQI from melatonin randomization day (Day 0) to Day 14 ]Pittsburgh Sleep Quality Index (PSQI); range is 0-21, with higher scores indicating poorer sleep
- Decreased actigraph-measured sleep latency [ Time Frame: Change in actigraph-measured sleep onset latency from melatonin randomization day (Day 0) to Day 14 ]How long it takes a participant to fall asleep; Actigraphs from the Actigraph Company will be used to analyze the data using Actilife software. Sleep latency is an Actilife software outcome.
- Increased actigraph-measured sleep efficiency [ Time Frame: Change from Randomization day (Day 0) to Day 14. ]Amount of time participant spends sleeping divided by the amount of time the patient spends in bed. Actigraphs from the Actigraph Company will be used to analyze the data using Actilife software. Sleep efficiency is an Actilife software outcome.
- Lower autocorrelation function [ Time Frame: Change in actigraph-measured autocorrelation from melatonin randomization day (Day 0) to Day 14 ]Ac is the slope of the time correlation line (log-trans- formed); indicative of rhythm fragmentation; lower values represent less fragmented rhythms. Actigraphs from the Actigraph Company will be used to analyze the data using Actilife software. Autocorrelation function is an Actilife software outcome.
- Increased activity (M10) [ Time Frame: Change in actigraph-measured M10 from melatonin randomization day (Day 0) to Day 14 ]mean activity level during the most active 10 h of the day; higher values are indicative of a more active lifestyle. M10 is an Actilife software output.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826563
|Contact: Jerome H Taylor, MDemail@example.com|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Jerome Taylor firstname.lastname@example.org|
|Principal Investigator:||Raquel Gur, MD||Children's Hospital of Philadelphia|