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.
Data Collection
Collected from today forward - ProspectiveAutism Spectrum Disorder+3
+ Mental Disorders
+ Child Development Disorders, Pervasive
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: January 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.38 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 18 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations