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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01669889

Enrollment

Registered

2012-08-21

Start date

2013-01-31

Completion date

2013-12-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer, Autistic Disorder, Asperger's Syndrome

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Behavior assessment ratings	approximately 5 months
Cognition assessment ratings	approximately 5 months

Countries

United States

Outcome results