The objective of this protocol is to establish a comprehensive screening process for the
evaluation of eligibility for entry in a clinical trial program for children and adolescents
with bipolar disorder.
To address the urgent therapeutic needs of children and adolescents ages 4-17 with pediatric
bipolar disorder, we have designed a series of clinical trials aimed at evaluating critical
components of the treatment needs of this under-served and under-researched population. This
approach will allow us to provide a full complement of clinical trials that will meet the
most pressing needs of the bipolar children and adolescents and their families who are
currently awaiting treatment.
Although these protocols have received prior IRB approval, potential participants present
with a widely varied set of complaints not always discernable in a telephone screening
interview. This state of affairs makes it very difficult to ask subjects to sign a specific
clinical protocol without obtaining additional clinical information. Because of this we are
proposing potential subjects to consent to undergo an in-depth clinical assessment that will
allow subjects to be screened by a clinician for eligibility to a diverse clinical trials
program available to them.
- Males and females age 4 to 17 inclusive with a suspected diagnosis of bipolar
- 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
- 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