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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT00571402
Eligibility Criteria:
Inclusion Criteria:
* Meets DSM-IV criteria for bipolar I, bipolar II, or not otherwise specified (NOS) disorder based on independent Kiddie Schedule for Affective Disorders and Schizophrenia and on present and lifetime version interviews with the patient and at least one parent
* Concurrent physician diagnosis of bipolar I, II, or NOS disorder based on a separate set of evaluations of the parent and child
* At least a 1-week episode of manic, mixed, or hypomanic symptoms or a 2-week episode of depressive symptoms within the 3 months prior to study entry
* Currently taking or willing to proceed with regular pharmacotherapy from a study psychiatrist
* At least one biological parent or step-parent with whom the patient lives who is willing to participate in treatment
Exclusion Criteria:
* History of severe, unremitting psychosis lasting more than 3 months
* Evidence of mental retardation (IQ less than 70), organic central nervous system (CNS) disorder, or pervasive developmental disorder
* Substance or alcohol dependence or abuse disorders in the 3 months prior to study entry
* Current life-threatening eating disorder or medical disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT00571402
Study Brief:
Protocol Section:
NCT00571402