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

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborators: Brain and Behavior Research Foundation (NARSAD Young Investigator Award, Grant Number 26742); University of Pennsylvania
• Treatments: Melatonin

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.