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

18-014932

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

2019-01-18

2023-04-07

2023-04-07

Completed

21

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.

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2023-05-09