Roche trials database

Trial information

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

Status:

Recruiting

Protocol number:

BP28421

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific 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.

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. Target sample size is 40.

Study phase:

I

Study type:

Observational study

Conditions:

• Healthy Volunteer
• Autistic Disorder
• Asperger's Syndrome

Primary outcome:

1. Behavior assessment ratings Time frame: approximately 5 months
2. Cognition assessment ratings Time frame: approximately 5 months

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

Gender:

Males

Age limits:

Min: 18 years Max: 45 years

Anticipated start date:

January, 2013

Trial registration date:

02.07.2012

Date last updated:

06.05.2013

This trial is being conducted at the following locations:

U.S.A.

• LOS AGELES, CA
• NEW YORK, NY

Link to trial result