Status:
COMPLETED
Melatonin Effects on Sleep and Circadian Rhythm in Youth and Young Adults With At-risk Symptoms
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
University of Pennsylvania
Brain and Behavior Research Foundation (NARSAD Young Investigator Award, Grant Number 26742)
Conditions:
Psychosis
Sleep
Eligibility:
All Genders
11-30 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03826563
Start Date
January 18 2019
End Date
April 7 2023
Last Update
May 9 2023
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104