A Non-Drug Study on the Relationship Between Exploratory Biomarkers and Functional Dimensions in Individuals With Autistic Disorder or Asperger's Syndrome
NCT ID: NCT01669889
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
38 participants
OBSERVATIONAL
2013-01-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Male adults, 18 to 45 years of age inclusive
* Diagnosis of Autistic Disorder or Asperger's Syndrome as defined by DSM-IV
* IQ \>70
* Body mass index (BMI) 18 to 35 kg/m2
* Availability of a reliable caregiver, able and willing to provide information regarding the individual's behavior and symptoms
Healthy controls:
* Healthy male adults, 18 to 45 years of age inclusive
* IQ \>70
* Body mass index (BMI) 18 to 30 kg/m2
Exclusion Criteria
* Confirmed systolic blood pressure \>140 or \<90 mmHg, and diastolic blood pressure \>90 or \<50 mmHg
* Resting pulse rate \>100 or \<40 beats per minute
* Alcohol and/or substance abuse/dependence during the last 12 months
* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Additionally for individuals with Autistic Disorder or Asperger's Syndrome:
* History of epilepsy/seizure disorder (except simple febrile seizures)
* Significant disruptive, aggressive or self-injurious, or sexually inappropriate behavior during the last 3 months that in the opinion of the investigator might interfere with the conduct of the study
Additionally for healthy controls:
* Clinically significant abnormalities in laboratory test results
* History of or current psychiatric, neurological disorder or pervasive developmental disorder
18 Years
45 Years
MALE
Yes
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Los Ageles, California, United States
New Haven, Connecticut, United States
New York, New York, United States
Countries
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Other Identifiers
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BP28421
Identifier Type: -
Identifier Source: org_study_id