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:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT00748761
Eligibility Criteria:
Inclusion Criteria:
* Meets DSM-IV diagnostic criteria for OCD as primary diagnosis, based on the Anxiety Disorders Interview Schedule (ADIS) Clinical Severity Rating
* Clinical Global Impressions severity score of at least 4, reflecting moderately ill or worse status
* Children's Yale-Brown Obsessive Compulsive Scale total score of greater than or equal to 16
* No medication for OCD or other psychiatric condition in the past 4 weeks and no use of fluoxetine for the past 6 weeks
* Child is fluent in English
* Parental informed consent and child or adolescent informed assent forms are signed
* For females of childbearing potential a negative pregnancy test will be required for study entry
Exclusion Criteria:
* IQ of less than 80 on the Wechsler Abbreviated Scales of Intelligence
* A lifetime DSM-IV diagnosis of pervasive developmental disorder, mania, psychosis, conduct disorder, or substance dependence assessed through ADIS
* Current DSM-IV diagnosis of major depressive disorder or attention deficit hyperactivity disorder any subtype, assessed through an ADIS rating of 4 or higher
* Any serious psychiatric, psychosocial, or neurological condition, such as a tic disorder, non-OCD anxiety, aggression, or family discord, that requires immediate treatment other than that provided in the current study
* One or more failed adequate trials of exposure-based CBT, defined as at least 10 sessions of therapist-assisted, exposure-based CBT with which the patient voluntarily complied
* More than one failed selective serotonin reuptake inhibitor trial adequate in dose and duration, defined as at least 8 weeks of treatment with at least 20 mg of fluoxetine, 20 mg of paroxetine, 75 mg of sertraline or fluvoxamine, or 75mg of clomipramine
* Any body metal (other than dental fillings), pregnancy, or other contraindications to MRSI scan
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT00748761
Study Brief:
Protocol Section:
NCT00748761