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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826563
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : January 29, 2020
Sponsor:
Collaborators:
University of Pennsylvania
Brain and Behavior Research Foundation (NARSAD Young Investigator Award, Grant Number 26742)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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

Condition or disease Intervention/treatment Phase
Psychosis Sleep Drug: oral melatonin tablets (NatureMade brand) Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Only the pharmacy will know the randomization arms.
Primary Purpose: Other
Official Title: Melatonin Effects on Sleep and Circadian Rhythm in Youth and Young Adults With At-risk Symptoms
Actual Study Start Date : January 18, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects will receive pill placebo nightly
Other: Placebo
pill placebo

Experimental: Melatonin
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)
melatonin tablets




Primary Outcome Measures :
  1. Actigraph-measured sleep (increased total sleep time) [ Time Frame: Change in total sleep time from melatonin randomization day (Day 0) to Day 14 ]
    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.


Secondary Outcome Measures :
  1. Improved self-reported sleep [ Time Frame: Change in total PSQI from melatonin randomization day (Day 0) to Day 14 ]
    Pittsburgh Sleep Quality Index (PSQI); range is 0-21, with higher scores indicating poorer sleep


Other Outcome Measures:
  1. Decreased actigraph-measured sleep latency [ Time Frame: Change in actigraph-measured sleep onset latency from melatonin randomization day (Day 0) to Day 14 ]
    How long it takes a participant to fall asleep; Actigraphs from the Actigraph Company will be used to analyze the data using Actilife software. Sleep latency is an Actilife software outcome.

  2. Increased actigraph-measured sleep efficiency [ Time Frame: Change from Randomization day (Day 0) to Day 14. ]
    Amount of time participant spends sleeping divided by the amount of time the patient spends in bed. Actigraphs from the Actigraph Company will be used to analyze the data using Actilife software. Sleep efficiency is an Actilife software outcome.

  3. Lower autocorrelation function [ Time Frame: Change in actigraph-measured autocorrelation from melatonin randomization day (Day 0) to Day 14 ]
    Ac is the slope of the time correlation line (log-trans- formed); indicative of rhythm fragmentation; lower values represent less fragmented rhythms. Actigraphs from the Actigraph Company will be used to analyze the data using Actilife software. Autocorrelation function is an Actilife software outcome.

  4. Increased activity (M10) [ Time Frame: Change in actigraph-measured M10 from melatonin randomization day (Day 0) to Day 14 ]
    mean activity level during the most active 10 h of the day; higher values are indicative of a more active lifestyle. M10 is an Actilife software output.



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826563


Contacts
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Contact: Jerome H Taylor, MD 267-536-9405 taylorje@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jerome Taylor       taylorje@pennmedicine.upenn.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
University of Pennsylvania
Brain and Behavior Research Foundation (NARSAD Young Investigator Award, Grant Number 26742)
Investigators
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Principal Investigator: Raquel Gur, MD Children's Hospital of Philadelphia
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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03826563    
Other Study ID Numbers: 18-014932
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will share data within the CHOP research group.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants