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

NCT03826563 | Completed

• 1 other identifier: 18-014932
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psychosis; Sleep

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improved self-reported sleep

  Change in total PSQI from melatonin randomization day (Day 0) to Day 14

Other Outcomes (4)

• Decreased actigraph-measured sleep latency

  Change in actigraph-measured sleep onset latency from melatonin randomization day (Day 0) to Day 14

• Increased actigraph-measured sleep efficiency

  Change from Randomization day (Day 0) to Day 14.

• Lower autocorrelation function

  Change in actigraph-measured autocorrelation from melatonin randomization day (Day 0) to Day 14

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects will receive pill placebo nightly

Other: Placebo

Melatonin

EXPERIMENTAL

Subjects will receive oral melatonin tablets 2.5-10mg nightly for 2 weeks. All will receive melatonin 5mg for one week, then at the 1 week visit, the dose can be continued at 5mg or adjusted to 2.5mg or 10mg nightly based on clinical assessment of patient response and side effects.

Drug: oral melatonin tablets (NatureMade brand)

Interventions

oral melatonin tablets (NatureMade brand) DRUG

melatonin tablets

Melatonin

Placebo OTHER

pill placebo

Placebo

Eligibility Criteria

• Age: 11 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator
• Brain and Behavior Research Foundation (NARSAD Young Investigator Award, Grant Number 26742): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Raquel Gur, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the pharmacy will know the randomization arms.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: February 1, 2019
• Study Start: January 18, 2019
• Primary Completion: April 7, 2023
• Study Completion: April 7, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)