Autistic DisorderNCT01984944
Characterisation of Circadian Rhythm in Autistic Spectrum Disorder
A study testing Autistic functional exploration in people with Autistic Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Autistic functional exploration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Aug 2013
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Recent sleep symptoms
- Incapacity to keep rested for 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterisation of Circadian Rhythm in Autistic Spectrum Disorder : a Clinical, Biochemical and Genetic Study
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.
- Conditions
- Autistic Disorder
- Being tested
- Autistic functional exploration, Control functional exploration
- Keywords
- circadian rhythm
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autistic functional explorationOther
- 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 explorationOther
- 50 adults with urinary sample, core body temperature rhythm, Circadian rhythms assessed with actometer
- 25 childs with urinary sample, Circadian rhythms assessed with actometer
| Study group | Role | What they receive |
|---|---|---|
| Autistic Patient | Other | * 50 adults
* 25 childs Receives: Other: Autistic functional exploration |
| Controls | Other | * 50 adults
* 25 childs Receives: Other: Control functional exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary sulfatoxymelatonin secretion
Measured: The determination will be performed at 14 days ( child)
Urinary sulfatoxymelatonin secretion
Measured: The determination will be performed at 21 days ( adults)
Secondary outcomes (2)
Core body temperature rhythm
Measured: The determination will be performed at 5 days (adult)
Circadian rhythms assessed with actometer
Measured: The determination will be performed at 14 ( child) and 21 days (adult)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startOct 2009
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Henri Mondor University Hospital, Albert Chenevier Hospital (Department of Psychiatry), Hopital Universitaire Robert-Debre, Pasteur Institute (Cognitive Function and Human Genetic), Fondation FondaMental
- Responsible party
- Sponsor
- Investigators
- Xavier DROUOT, MCU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984944
- Sponsor's protocol ID
- P081103
- Other IDs
- 2009-011842-24, 2009
- Status last verified
- Nov 2014
- First submitted
- 29 Oct 2013
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Circadian Rhythm in Autistic Spectrum Disorder : a Clinical, Biochemical and Genetic Study
- ClinicalTrials.gov ID
- NCT01984944
- Acronym / sponsor ID
- P081103
- Conditions
- Autistic Disorder
- Keywords
- circadian rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Henri Mondor University Hospital, Albert Chenevier Hospital (Department of Psychiatry), Hopital Universitaire Robert-Debre, Pasteur Institute (Cognitive Function and Human Genetic), Fondation FondaMental
- Study start
- Oct 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 15 Nov 2013 (estimated)
- 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autistic Patient | Other | Other: Autistic functional exploration* 50 adults * 25 childs |
| Controls | Other | Other: Control functional exploration* 50 adults * 25 childs |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Recent sleep symptoms
- Incapacity to keep rested for 24 hours
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 |
|---|---|---|
| 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 | Other | Autistic Patient |
| 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 | Other | Controls |
Primary outcome
Urinary sulfatoxymelatonin secretion
Time frame: The determination will be performed at 14 days ( child)
Urinary sulfatoxymelatonin secretion
Time frame: The determination will be performed at 21 days ( adults)
2 secondary outcomes
Core body temperature rhythm
Time frame: The determination will be performed at 5 days (adult)
Circadian rhythms assessed with actometer
Time frame: The determination will be performed at 14 ( child) and 21 days (adult)
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 7 Nov 2014.
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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.
Xavier DROUOT, MCU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autistic functional exploration in people with Autistic Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 2 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 7 Nov 2014. 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 France. 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. 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?
Urinary sulfatoxymelatonin secretion (time frame: The determination will be performed at 14 days ( child)). The study lists 2 primary outcomes in all. 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 7 Nov 2014.