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Completed

NCT Number: NCT01669889

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Observational

Primary location

Los Ageles, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Behavior assessment ratings

    Time frame: approximately 5 months

  2. Cognition assessment ratings

    Time frame: approximately 5 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 21, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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