Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT00515320
Eligibility Criteria:
Inclusion Criteria:
* Meets DSM-IV criteria for autistic disorder, .
* CYBOCS-PDD score of at least 10 at screening.
Exclusion Criteria:
* Diagnosis of Asperger Syndrome or Pervasive Developmental Disorder Not Otherwise Specified, Rett Syndrome, Childhood Disintegrative Disorder.
* Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment.
* Patients who are currently taking fluoxetine or who have previously taken it are not eligible for the study.
Other protocol-defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT00515320
Study Brief:
Protocol Section:
NCT00515320