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 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
NCT ID:
NCT00338806
Eligibility Criteria:
Inclusion Criteria for Parents:
* Diagnosis of BD I or II
* Currently in partial or full remission from a depressive or manic episode
* Under active clinical care
Inclusion Criteria for Adolescents:
* Speaks English or Spanish
* Presence of at least one current mood symptom meeting DSM-IV Criterion A and at least one depression or mania symptom meeting DSM-IV Criterion B
* Depression, irritability, anhedonia, or elated mood scored at level 2 or 3 on the KSADS-PL
* Mania symptom scored at level 2 or 3 on the KSADS-PL scale
* Score of less than 40 on the CDRS-R scale
* Score of less than 15 on the YMRS scale
* Mild-moderate functional impairment, defined as a score of greater than 61 and less than 75 on the C-GAS scale
Exclusion Criteria for Parents:
* History of psychosis within 1 month of study entry
* At risk for suicide within 1 month of study entry
Exclusion Criteria for Adolescents:
* Past major depressive or manic episode
* Current or past psychosis
* History of suicide attempts
* Current substance use disorder
* Use of psychotropic medications and other medications that might impact mood (e.g., steroids)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT00338806
Study Brief:
Protocol Section:
NCT00338806