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Research and Clinical Trials
Your child or family members may be eligible to participate in one of the research studies on bipolar disorder listed below.
About Research and Clinical Trials
Scientific research offers great hope to families affected by bipolar disorder. Participation in studies enables families to contribute directly to research that may lead to discoveries that lessen the burden of bipolar illness for current and future generations. Not all studies include treatment. Benefits may include a chance to be evaluated by an expert on the disorder, try a new medication not widely available, receive free treatment (including additional diagnostic tests) during the period of the study, and a period of follow-up care.
Before putting your child in a study, CABF suggests you ask questions to learn about the study and help you determine whether being in the study is in your child's best interests. The National Institute of Mental Health suggests the following Checklist of Questions:
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Why do you want me in your study?
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What is the research about? How will this research help in treating or understanding my disorder?
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What do I need to do and how much time will this take?
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How might this study help me, my relatives, or other people with my disorder?
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What possible risks are there to me or my relatives if I take part?
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How will this be different from the care I am getting now, and do I have other options or choices?
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Could my illness become worse during the study? What will happen if it does?
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What will happen to me at the end of the study?
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What should I do if I want to drop out of the study?
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May I get back to you after I discuss this with my family/friend/case manager/doctor?
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For more information, see the FDA and NIMH's guides, Should Your Child Be in a Clinical Trial?
and A Participant's Guide to Mental Health Clinical Research.
For a summary of research on bipolar disorder at the National Institute of Mental Health, see this Fact Sheet.
To view additional ongoing trials, visit www.clinicaltrials.gov
Definitions of Research Terms
http://www.rush.edu/rumc/page-1120170890846.html
Research and Clinical Trials Funding
Most research on bipolar illness is funded by:
- National Institute of Mental Health (NIMH)
The NIMH (funded by Congress) supports large, multi-site studies on pediatric bipolar disorder that are conducted at university research centers. It also conducts smaller studies by researchers on staff at its main campus in Bethesda, MD, and funds Research Roundtables and an annual scientific pediatric bipolar disorder conference.
- Stanley Medical Research Institute
Privately funded by Ted and Vada Stanley to fund basic research on causes and treatment of bipolar disorder and schizophrenia. Since 1989 has awarded over $130 million in research grants with special focus on neuropathology, neurovirology/neuroimmunology, and research relevant to developing better treatments including pilot testing of novel, generic, and off-label compounds and nutritional supplements.
- NARSAD (National Alliance for Research on Schizophrenia and Depression) Founded in 1986 by a coalition of nonprofit mental health advocacyorganizations, NARSAD raises and distributes funds for brain disorderresearch. Many of CABF’s Scientific Advisory Council members receive funding from NARSAD for their work on pediatric bipolar disorder, and itsgrants (click here for a list of research funded over past 4 years) often lead to federal funding. Since 1987 NARSAD has awarded $139.9 million in research grants to 1,695 scientists at 212 leading universities, institutes and teaching hospitals in the U.S. and in 20 other countries. Individuals and family foundations may become NARSAD Research Partners to support proposals reviewed by its Scientific Council.
- The pharmaceutical industry develops new drugs and tests existingdrugs for treatment of bipolar disorder under oversight by the Food & DrugAdministration (FDA). Issues about testing pharmaceutical treatments for use in children are described in Drug Research in Children.
Criteria for posting studies on this site
The Child & Adolescent Bipolar Foundation has established a Research Committee that includes board members and members of its Scientific Advisory Board. In order for a study to be accepted for listing on this site, the Research Committee must find the following:
- The study design appears likely to produce scientifically meaningful information
- The study appears to have a favorable risk-benefit ratio for subjects
- The study has been approved by an Institutional Review Board
To submit a study for posting on this site
For each study, please submit the following:
- Protocol for the study (must identify sponsor, principal investigator, and name of medication(s), if any)
- Consent/assent forms
- A one-paragraph description for posting, if accepted
- IRB approval letter
Documents should be e-mailed to the CABF Research Committee at cabf@bpkids.org in Microsoft Word format. Fax the IRB letter to (847)492-8520. Documents will be handled in confidence for discussion with the Research Committee of CABF. The CABF Research Committee will review the materials and notify you if the study meets its criteria as set forth above. CABF charges $25 per month for listing of studies approved by the Research Committee.
Disclaimer
The Child & Adolescent Bipolar Foundation (CABF) lists research studies open to children and adolescents as an educational and information service only. The posting of research studies on this Web site is not an endorsement or recommendation of such studies. There are many other studies which, for various reasons, may not be listed here. CABF makes no representations or warranties with respect to quality, efficacy, safety, reliability, qualifications, or desirability of the studies or researchers, and specifically disclaims any other warranties, express or implied.
Studies
On-Line Surveys (none currently available)
National-U.S.A.
The National Institute of Mental Health
Currently seeking children between the ages of 6-17 years old with bipolar disorder.
Johns Hopkins University
Currently seeking children ages 8-17 who are taking olanzapine (Zyprexa®), quetiapine (Seroquel®), or risperidone (Risperdal®), and have gained a significant amount of weight in the past year while taking one of these medications.
Bethesda, MD
The National Institute of Mental Health
Currently seeking children between the ages of 6-17 years old with bipolar disorder.
Stanford, California
Stanford University
The Pediatric Bipolar Disorders Program of the Department of Psychiatry and Behavioral Sciences at Stanford University School of Medicine is conducting a study, "The Evaluation of Lamotrigine as an add-on treatment for Bipolar I disorder in children and adolescents", and is seeking children ages 10-17 with Bipolar Disorder I who take medications but are still experiencing mood symptoms.
Chicago, Illinois
University of Illinois at Chicago
Currently seeking children and adolescents to participate in a research study. Subjects agse 10-16 will be asked to participate in an 8-week trial of lithium in the treatment of pediatric bipolar disorder. We also seek 10-16 year old healthy youths to compare the patients with typically developing youths.
University of Illinois at Chicago
Currently seeking families to participate in the research study, "Bipolar and Schizophrenia Network on Intermediate Phenotypes (BSNIP)". This program is for patients and their first-degree family members. Eligibility: ages 15-65; an individual with a diagnosis of Bipolar I disorder or Schizophrenia/Schizoaffective and at least one first degree full biological family member (i.e., mother, father, full sibling, or child) who may or may not have a psychiatric illness.
Baltimore, MD
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