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

This study is currently recruiting participants.
Verified June 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01669889
First received: August 15, 2012
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition
Asperger's Syndrome, Healthy Volunteer, Autistic Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-center, Non-drug Study to Explore the Relationship Between Exploratory Biomarkers and Functional Dimensions in Individuals With Autistic Disorder or Asperger's Syndrome.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Behavior assessment ratings [ Time Frame: approximately 5 months ] [ Designated as safety issue: No ]
  • Cognition assessment ratings [ Time Frame: approximately 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

High functioning (IQ >70) male adult individuals with Autistic Disorder or Asperger's Syndrome and age and IQ matched healthy male volunteers

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669889

Contacts
Contact: Reference Study ID Number: BP28421 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United States, California
Recruiting
Los Ageles, California, United States, CA 90095
United States, New York
Recruiting
New York, New York, United States, 10021
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01669889     History of Changes
Other Study ID Numbers: BP28421
Study First Received: August 15, 2012
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Autistic Disorder
Asperger Syndrome
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013