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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669889
First Posted: August 21, 2012
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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
Healthy Volunteer, Autistic Disorder, Asperger's Syndrome

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.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Behavior assessment ratings [ Time Frame: approximately 5 months ]
  • Cognition assessment ratings [ Time Frame: approximately 5 months ]

Enrollment: 38
Study Start Date: January 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669889


Locations
United States, California
Los Ageles, California, United States, 90095
United States, Connecticut
New Haven, Connecticut, United States, 06510
United States, New York
New York, New York, United States, 10021
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01669889     History of Changes
Other Study ID Numbers: BP28421
First Submitted: August 15, 2012
First Posted: August 21, 2012
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Disease
Syndrome
Autistic Disorder
Asperger Syndrome
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders


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