Participants will be followed and treated in a consistent manner throughout their involvement in the study, even when they are feeling well. In more traditional clinical trials, individuals participate only for a limited time and have limited treatment options. NIH is part of the U.S. Department of Health and Human Services. Individuals younger than age 18 need permission from a parent or legal guardian to participate. STEP-BD will enroll approximately 5,000 participants.
Participation is entirely voluntary - people are always free to leave the study.
Participants' privacy and confidentiality will be protected at all times. STEP-BD is being conducted at research centers around the United States. Currently there are 17 sites in operation, and up to two more may be added for a total of 20 sites. Participants receive treatment from psychiatrists who are specially trained in the treatment of bipolar disorder based on current best-practice guidelines. Clinical specialists at each STEP-BD site assist the doctors in monitoring each participant's progress.