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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826563
• Other study ID #: 18-014932
• Status: Completed
• Phase: N/A
• Start date: January 18, 2019
• Est. completion date: April 7, 2023

Study information

• Verified date: May 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 7, 2023
• Est. primary completion date: April 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 30 Years

Eligibility

Inclusion Criteria:

• Males or females age 11-30 years old and patient at the Children's Hospital of Philadelphia (CHOP), University of Pennsylvania (UPenn), or member of the surrounding community
• 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 have difficulties with sleep onset, sleep awakenings, or maintaining a regular sleep schedule.
• Willingness to report all changes in medications and therapy during the study
• Intelligence Quotient (IQ) > 70
• If female, not breastfeeding and not pregnant and willing to use effective birth control for the duration of the study (e.g. abstinence or oral contraception).
• Medically healthy
• Fluent in English

Exclusion Criteria:

• Psychiatric symptoms with imminent safety concern (e.g. intractable and escalating suicidal ideation)
• Currently taking melatonin, having taken melatonin daily within the 2 weeks prior to Visit 1, or having a history of an intolerance or allergy to melatonin.
• Medication or treatment changes in the 4 weeks prior to Visit 1 .
• Anticipated medication or other treatment (e.g. type of psychotherapy) changes in the three weeks after study enrollment.
• IQ <70
• Taking any medication whose potential interactions with melatonin present a significant risk or limit the effect of melatonin in the judgment of the investigators.

Related Conditions & MeSH terms

• Psychosis
• Psychotic Disorders
• Sleep

Intervention

Drug:
• oral melatonin tablets (NatureMade brand)
melatonin tablets

Other:
• Placebo
pill placebo

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Brain and Behavior Research Foundation (NARSAD Young Investigator Award, Grant Number 26742), University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Decreased actigraph-measured sleep latency	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.	Change in actigraph-measured sleep onset latency from melatonin randomization day (Day 0) to Day 14
Other	Increased actigraph-measured sleep efficiency	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.	Change from Randomization day (Day 0) to Day 14.
Other	Lower autocorrelation function	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.	Change in actigraph-measured autocorrelation from melatonin randomization day (Day 0) to Day 14
Other	Increased activity (M10)	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.	Change in actigraph-measured M10 from melatonin randomization day (Day 0) to Day 14
Primary	Actigraph-measured sleep (increased total sleep time)	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.	Change in total sleep time from melatonin randomization day (Day 0) to Day 14
Secondary	Improved self-reported sleep	Pittsburgh Sleep Quality Index (PSQI); range is 0-21, with higher scores indicating poorer sleep	Change in total PSQI from melatonin randomization day (Day 0) to Day 14