Characterisation of Circadian Rhythm in Autistic Spectrum Disorder

Autistic Disorder Clinical Trial

Official title:

Characterisation of Circadian Rhythm in Autistic Spectrum Disorder : a Clinical, Biochemical and Genetic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984944
• Other study ID #: P081103
• Secondary ID: 2009-011842-24
• Status: Completed
• Phase: N/A
• First received: October 29, 2013
• Last updated: November 6, 2014
• Start date: October 2009
• Est. completion date: August 2013

Study information

• Verified date: November 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Autism spectrum disorders (ASDs) are complex neurodevelopmental conditions characterized by deficits in social communication, delay in language and repetitive behaviors. Results from genetic studies reveal one pathway associated with susceptibility to ASDs, which includes synaptic cell adhesion molecules. Among the factors that could modulate this pathway are the genes controlling circadian rhythms. Sleep disorders and low melatonin levels are frequently observed in ASDs. Thus investigator will characterize the circadian rhythms of patients with ASD and search for circadian rhythms genes polymorphisms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Patients with autistic spectrum disorders

• At least 6 years old

• Membership of a social security scheme

• Informed consent signed by the patient or both holders of parental authority if the subject is a minor, or by a guardian if the subject is under guardianship

Exclusion Criteria:

• Recent sleep symptoms

• Incapacity to keep rested for 24 hours

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Other:
• Autistic functional exploration
50 adults with urinary sample, core body temperature rhythm, Circadian rhythms assessed with actometer 25 childs with urinary sample, Circadian rhythms assessed with actometer
• Control functional exploration
50 adults with urinary sample, core body temperature rhythm, Circadian rhythms assessed with actometer 25 childs with urinary sample, Circadian rhythms assessed with actometer

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (6)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Albert Chenevier Hospital (Department of Psychiatry), Fondation FondaMental, Henri Mondor University Hospital, Pasteur Institute (Cognitive Function and Human Genetic), Robert Debré Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary sulfatoxymelatonin secretion		The determination will be performed at 14 days ( child)	No
Primary	Urinary sulfatoxymelatonin secretion		The determination will be performed at 21 days ( adults)	No
Secondary	Core body temperature rhythm		The determination will be performed at 5 days (adult)	No
Secondary	Circadian rhythms assessed with actometer		The determination will be performed at 14 ( child) and 21 days (adult)	No