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:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
NCT ID:
NCT00183612
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of bipolar disorder with mania, mixed mania, or psychosis not otherwise specified
* Meet certain laboratory result requirements
* Have taken either lithium or valproate for 4 weeks or longer with no or only partial response
* Parent or guardian willing to provide informed consent
Exclusion Criteria:
* History of other serious unstable illness requiring medication
* Diabetes mellitus
* Abnormal physical examination and electrocardiogram (EKG) results
* At risk for suicide or homicide (based on an assessment of suicidal history, intent or plan, mental state, mood, and substance use)
* IQ less than 65
* History of organic brain disease or seizure disorder
* Recent exposure to an infectious disease, such as tuberculosis (TB) or meningitis
* Current use of drugs that may interfere with the metabolism of olanzapine and unwilling to discontinue use during the study
* Body mass index (BMI) less than the 5th OR greater than the 95th percentile for age and gender
* History of smoking within 1 year prior to study entry
* Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT00183612
Study Brief:
Protocol Section:
NCT00183612