A Non-Drug Study on the Relationship Between Exploratory Biomarkers and Functional Dimensions in Individuals With Autistic Disorder or Asperger's Syndrome

Completed

Conditions studied: Healthy Volunteer, Autistic Disorder, Asperger's Syndrome

In brief

This multi-center, non-drug study will explore the relationship between exploratory biomarkers and functional dimensions in male adult individuals with Autistic Disorder or Asperger's Syndrome and healthy volunteer controls. Subjects will undergo a number of assessments on study visit Day 1.

Key facts

Study ID

NCT01669889

Run by

Hoffmann-La Roche

People needed

38

Starts

2013-01-01

Expected to finish

2013-12-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Individuals with Autistic Disorder or Asperger's Syndrome:
• 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

You may not qualify if…

• General exclusion criteria:
• Positive test for drugs of abuse or alcohol
• 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

Where it is running

• Study site — Los Ageles, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — New York, New York, United States

Full record on ClinicalTrials.gov

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