Research Studies
Click here for a list of research studies and clinical trials currently recruiting participants.
Disclaimer
The Balanced Mind Foundation 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. The Balanced Mind Foundation 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.
About Research and Clinical Trials
Scientific research offers great hope to families affected by mood disorders. 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, The Balanced Mind Foundation 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? |
For more information, see the FDA's guide, Should Your Child Be in a Clinical Trial?
For a summary of research on bipolar disorder at the National Institute of Mental Health, see this Fact Sheet.
Definitions of Research Terms
http://www.rush.edu/research/patients-definitions.html
Research and Clinical Trials Funding
- Most research on bipolar disorder 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. - Brain & Behavior Research Foundation(formerly "NARSAD") Founded in 1986 by a coalition of nonprofit mental health advocacy organizations, Brain & Behavior Research Foundation raises and distributes funds for brain disorder research. Many of The Balanced Mind Foundation’s Scientific Advisory Council members receive funding from Brain & Behavior Research Foundation for their work on pediatric bipolar disorder, and its grants often lead to federal funding. Since 1987 Brain & Behavior Research Foundation 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 Research Partners to support proposals reviewed by its Scientific Council.
- The pharmaceutical industry develops new drugs and tests existing drugs for treatment of mood disorders under oversight by the Food & Drug Administration (FDA). From Test Tube to Patient describes how new drugs are brought to market through clinical trials by pharmaceutical companies under the oversight of the 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 Balanced Mind Foundation has established a Research Committee that includes board members and members of its Professional 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 The Balanced Mind Foundation Research Committee at info@thebalancedmind.org in Microsoft Word format. Documents will be handled in confidence for discussion with the Research Committee of The Balanced Mind Foundation. The The Balanced Mind Foundation Research Committee will review the materials and notify you if the study meets its criteria as set forth above. The Balanced Mind Foundation charges a reasonable fee for listing of studies approved by the Research Committee.