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 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT00480168
Eligibility Criteria:
Inclusion Criteria:
* Atypical Antipsychotic naive patients who have agreed to take Atypical Antipsychotic medication upon the recommendation of their physician based on the child and their symptoms as per their usual patient care
* Outpatients and inpatients
* A wide range of patients including those with ADHD, Tourette's disorder, anxiety, disruptive behavior and mood instability as well as psychosis
* Children and adolescents aged 6 through 18 years
* Both sexes
* Females who have reached menarche and are sexually active who agree to use adequate birth control
* Patients who are willing to give informed assent/consent
* Guardians willing to give informed consent, if needed
* No initiation of or changes of doses of other psychotropic medication prescribed for the indication of which the atypical antipsychotic is being prescribed in the preceding month.
Exclusion Criteria:
* Patients with eating disorders (this condition might affect the expected weight and metabolic changes anticipated with the medications)
* Concurrent medical conditions including diabetes or hyperlipidemia if, in the judgment of the treating physician, the use of atypical anti-psychotics would be contra-indicated. (patient safety)
* Substance abuse (may effect the reliability of the patients or confound weight or metabolic effects of the medications)
* Pregnant or lactating patients (patient safety)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT00480168
Study Brief:
Protocol Section:
NCT00480168