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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT01495156
Eligibility Criteria:
Inclusion Criteria:
* Males and females, 12-18 years old, inpatients or outpatients
* meet DSM-IV criteria for Bipolar I disorder - manic or mixed episode
* psychotic symptoms present
Exclusion criteria:
* current serious homicidal/suicidal ideation
* prior non-response or intolerance to an adequate trial of lithium
* prior non-response or intolerance to adequate trials of both aripiprazole and risperidone
* any unstable medical condition or medical contraindication to treatment with lithium, aripiprazole or risperidone
* inability or unwillingness to discontinue concomitant medication that interferes with the pharmacokinetics of either lithium, aripiprazole, or risperidone
* seizure disorder
* pregnant or, if sexually active, not using birth control, such as oral contraceptives, two barrier methods, long-acting depot preparations or an intra-uterine device
* Full Scale IQ less than 70
* meets criteria for a DSM-IV diagnosis of substance-induced mood disorder or mood disorder due to a general medical condition.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT01495156
Study Brief:
Protocol Section:
NCT01495156