PsychosisNCT03826563
Melatonin Effects on Sleep and Circadian Rhythm in Youth and Young Adults With At-risk Symptoms
A study testing oral melatonin tablets (NatureMade brand) in people with Psychosis and Sleep, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Randomized control trial assessing supplemental melatonin for youth with at-risk or psychotic symptoms. Read more about this study
- Who is it for?
- Ages 11 to 30 years
- What is being tested?
- oral melatonin tablets (NatureMade brand)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2019to 7 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Randomized control trial assessing supplemental melatonin for youth with at-risk or psychotic symptoms.
Read the 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.
- Being tested
- oral melatonin tablets (NatureMade brand), Placebo
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral melatonin tablets (NatureMade brand)Drug
melatonin tablets
PlaceboOther
pill placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects will receive pill placebo nightly Receives: 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. Receives: Drug: oral melatonin tablets (NatureMade brand) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in total sleep time from melatonin randomization day (Day 0) to Day 14
Secondary outcomes (1)
Improved self-reported sleep
Pittsburgh Sleep Quality Index (PSQI); range is 0-21, with higher scores indicating poorer sleep
Measured: Change in total PSQI from melatonin randomization day (Day 0) to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start18 Jan 2019
- Primary completion7 Apr 2023
- Study completion7 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Brain and Behavior Research Foundation (NARSAD Young Investigator Award, Grant Number 26742)
- Responsible party
- Sponsor
- Investigators
- Raquel Gur, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826563
- Sponsor's protocol ID
- 18-014932
- Status last verified
- May 2023
- First submitted
- 17 Jan 2019
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share data within the CHOP research group.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Effects on Sleep and Circadian Rhythm in Youth and Young Adults With At-risk Symptoms
- ClinicalTrials.gov ID
- NCT03826563
- Acronym / sponsor ID
- 18-014932
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Brain and Behavior Research Foundation (NARSAD Young Investigator Award, Grant Number 26742)
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 7 Apr 2023 (actual)
- Study completion
- 7 Apr 2023 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboSubjects will receive pill placebo nightly |
| Melatonin | Experimental | Drug: oral melatonin tablets (NatureMade brand)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. |
Who may qualify
- Ages
- 11 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral melatonin tablets (NatureMade brand)melatonin tablets | Drug | Melatonin |
| Placebopill placebo | Other | Placebo |
Primary outcome
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.
1 secondary outcome
Improved self-reported sleep
Time frame: Change in total PSQI from melatonin randomization day (Day 0) to Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No. We will share data within the CHOP research group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raquel Gur, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral melatonin tablets (NatureMade brand) in people with Psychosis and Sleep, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actigraph-measured sleep (increased total sleep time) (time frame: Change in total sleep time from melatonin randomization day (Day 0) to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.