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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT00592267
Eligibility Criteria:
Inclusion Criteria:
* Males and females age 4 to 17 inclusive with a suspected diagnosis of bipolar disorder.
* Subject and parent/ legal guardian must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
* Subjects and their parent/ legal representative must be considered reliable.
* Each subject and his/her parent or authorized legal representative must understand the nature of the study. The subject's parent or authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
* One parent/ legal guardian must be able to accompany the subject to the clinic at each visit.
Exclusion Criteria:
* Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
* Serious, unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease
* Mental retardation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
17 Years
Study:
NCT00592267
Study Brief:
Protocol Section:
NCT00592267