Clinical trial NCT03826563: Melatonin Effects on Sleep and Circadian Rhythm in Youth and Young Adults With At-risk Symptoms
Official title: Melatonin Effects on Sleep and Circadian Rhythm in Youth and Young Adults With At-risk Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Sleep
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Brain and Behavior Research Foundation (NARSAD Young Investigator Award, Grant Number 26742)
First posted: 2019-02-01
Enrollment: 21
Sex: ALL
Minimum age (years): 11
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Actigraph-measured sleep (increased total sleep time)
timeFrame: Change in total sleep time from melatonin randomization day (Day 0) to Day 14
Secondary outcomes:
measure: Improved self-reported sleep
timeFrame: Change in total PSQI from melatonin randomization day (Day 0) to Day 14
Other outcomes:
measure: Decreased actigraph-measured sleep latency
timeFrame: Change in actigraph-measured sleep onset latency from melatonin randomization day (Day 0) to Day 14
measure: Increased actigraph-measured sleep efficiency
timeFrame: Change from Randomization day (Day 0) to Day 14.
measure: Lower autocorrelation function
timeFrame: Change in actigraph-measured autocorrelation from melatonin randomization day (Day 0) to Day 14
measure: Increased activity (M10)
timeFrame: Change in actigraph-measured M10 from melatonin randomization day (Day 0) to Day 14
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Raquel Gur, MD
role: PRINCIPAL_INVESTIGATOR
References: