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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT00113594
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients, 13 through 17 years of age (must not have reached their 18th birthday prior to Visit 1).
* Female patients must not be pregnant or nursing.
* Patient and patient's parent/authorized legal representative must have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must have given informed consent.
* Patient must have a previously documented diagnosis of schizophrenia or bipolar I according to the DSM-IV-TR, and either confirmed previously by K-SADS-PL or be confirmed by K-SADS-PL at Visit 1.
Exclusion Criteria:
* Patients must not be experiencing acute, serious, or unstable medical conditions other than schizophrenia or bipolar I disorder.
* Patients are not allowed into the study if they currently meet the criteria for the depressed phase of bipolar disorder or are diagnosed with Bipolar II Disorder.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
17 Years
Study:
NCT00113594
Study Brief:
Protocol Section:
NCT00113594