NCT01033565

Brief Summary

The purpose of this research is to see the effects (good and bad) of Melatonin CR on sleep in 4-8 year old children with autism spectrum disorders and sleep problems.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

March 4, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

September 9, 2013

Completed
Last Updated

September 8, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

December 14, 2009

Results QC Date

June 24, 2013

Last Update Submit

August 25, 2023

Conditions

Sleep Disorder

Keywords

Impaired sleep maintenanceAutism Spectrum DisordersPediatric

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impression-Improvement

    Assigns numerical score indicating level of improvement compared to baseline. Scale is rated from 1-7: 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; 7= very much worse.

    2 weeks

Study Arms (1)

Natrol

EXPERIMENTAL

Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days

Drug: Natrol

Interventions

NatrolDRUG

5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime.

Also known as: Sustained release melatonin
Natrol

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female children,
  • ages 4-8 years,
  • diagnosed with an ASD, including
  • Pervasive Developmental Disorder NOS (PDD, NOS),
  • Asperger's Syndrome, or
  • Autistic Disorder, and followed in the Munroe Meyer Developmental Pediatrics Clinic. Documented impaired sleep maintenance (ISM) based on parent-report and 7 day somnolog (sleep diary).
  • Clinician rating of 4 (moderately ill) or worse on CGI-S. Rating is based on the clinician's experience with evaluating and treating this patient population.
  • Previous discussion during a clinic appointment about sleep difficulties, including review of sleep hygiene and basic behavioral interventions/strategies.
  • Current problems of overnight awakenings recorded on the Children's Sleep Habits Questionnaire (CSHQ) despite behavioral intervention.
  • Stable psychotropic medication treatment for the past 4 weeks.

You may not qualify if:

  • Treatment with Melatonin or Melatonin CR during the past month or previous failed treatment with Melatonin CR.
  • Presence of a previously unevaluated medical condition which may be the etiology of the nighttime awakenings. There is no contraindication for use of Melatonin CR in patients with obstructive sleep apnea.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center-Munroe Meyer Institute

Omaha, Nebraska, 68198-5380, United States

Location

Related Publications (1)

  • Braam W, Smits MG, Didden R, Korzilius H, Van Geijlswijk IM, Curfs LM. Exogenous melatonin for sleep problems in individuals with intellectual disability: a meta-analysis. Dev Med Child Neurol. 2009 May;51(5):340-9. doi: 10.1111/j.1469-8749.2008.03244.x.

    PMID: 19379289BACKGROUND

MeSH Terms

Conditions

Sleep Wake DisordersAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersChild Development Disorders, PervasiveNeurodevelopmental Disorders

Limitations and Caveats

Unable to recruit a sufficient number of subjects to complete the study as designed.

Results Point of Contact

Title
Howard Needelman MD
Organization
University of Nebraska
hneedelm@unmc.edu
402-559-4097

Study Officials

  • Howard Needelman, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2009

First Posted

December 16, 2009

Study Start

March 4, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

September 8, 2023

Results First Posted

September 9, 2013

Record last verified: 2023-08

Locations

US(1)