Information for Participants

Clinical Trials Research

The Division of Bipolar Disorders Research conducts clinical trials (or treatment studies) of new and existing medications for the treatment of children, adolescents and adults with bipolar disorder, schizophrenia, and schizoaffective disorder. Pharmaceutical companies and foundations typically fund these studies.

Some of the studies are placebo-controlled, which means that some participants may not receive active medication while in the study, although they may receive other available treatments, such as psychotherapy. Placebo-controlled studies are performed in order to compare the improvement of people who receive active medication with those who do not.

Currently the U.S. Food & Drug Administration (FDA) requires placebo-controlled studies in order to gain FDA approval of any new medication for bipolar disorder. Typically, the placebo-controlled studies have a follow-up period during which the participant is assured active medication, and all participants in these types of studies are very carefully monitored to ensure safety. We are very selective of whom we will allow into a placebo-controlled study, limiting participation to people we believe fully understand the potential risks and who can remain in close communication with us at all times during the study.

Participation in a Clinical Trial
When a child, adolescent, or adult comes in for their initial appointment to inquire about participation, the first step is the consent process where all risks and benefits of study are explained. We do not allow subjects to participate in a study unless they are able to demonstrate clear understanding of these risks and benefits.

If the person chooses to continue after this step, then a diagnostic assessment is completed. This assessment determines whether the potential volunteer is eligible for the study. Eligibility criteria vary among studies. For example, some studies focus on the treatment of depression associated with bipolar disorder, whereas others focus on mania.

Most studies involve collecting blood and EKGs to monitor for any abnormalities that may be present prior to beginning the medication. Additionally, a physical exam will be performed and the presence of psychiatric symptoms will be assessed.

Study participation is always voluntary. At any point, from the signing of consent until the last study procedure is completed, participants may withdraw their consent and stop the study. While involved in a study, study medication and care related to the study, as well as all study procedures, are provided at no cost to the participant. In some cases, there may also funds available for transportation and parking.