NCT03826563

Melatonin Effects on Sleep and Circadian Rhythm in Youth and Young Adults With At-risk Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 11 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

Randomized control trial assessing supplemental melatonin for youth with at-risk or psychotic symptoms.

Detailed description

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.

Conditions

• Psychosis
• Sleep

Interventions

Type	Name	Description
DRUG	oral melatonin tablets (NatureMade brand)	melatonin tablets
OTHER	Placebo	pill placebo

Timeline

• Start date: 2019-01-18
• Primary completion: 2023-04-07
• Completion: 2023-04-07
• First posted: 2019-02-01
• Last updated: 2023-05-09

Locations

1 site across 1 country: United States