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Therapeutic Areas: Pediatrics/Neonatology | Psychiatry/Psychology | Family Medicine
Disease Category: Bipolar Disorders (Pediatric)
Location: United States, OH
Early-Onset Bipolar Medication Study
What is the purpose of this study?
This is a 7 to 8 week research study to compare the effectiveness
of Depakote or Risperdal with placebo (pretend medicine) in
children with bipolar disorder.
Who will be included in this study?
Children between the ages of 3 to 7 years old with bipolar disorder
may qualify to participate.
What is involved?
This study lasts 7 to 8 weeks and includes 8 to 9 visits. The
following is a list of procedures that will take place:
What are the benefits?
- Beginning phase - 1 to 2 visits lasting approximately 1 to 2
hours, to make sure your child meets requirements for the study:
- the study will be explained, and you and your child (if old
enough) will sign a consent form
- you and your child will answer questions to assess the degree
of bipolar disorder
- you will be given forms about your child’s symptoms, to take
home and complete at the beginning and end of the study
- your child will have blood drawn for laboratory testing, an EKG
(electrocardiogram or heart test) a physical, a medical and
psychiatric history taken and a psychiatric
- Treatment phase - 7 weekly visits lasting approximately 30
- your child will receive study medication, either Risperdal,
Depakote or placebo (80% chance of receiving real medication), and
will receive this medication at each visit
- you and your child will answer questions about symptoms of
bipolar disorder at each visit and medication will be adjusted
- your child will be monitored for side effects and any changes
- your child will have blood drawn 3 more times during the study
and have an EKG
- End of study phase - you will be referred to another
psychiatrist for ongoing treatment.
You or your child may or may not receive direct benefits from
participating in this study. There is a possibility that your
child’s bipolar disorder may improve; however, there is no
guarantee that your child will receive medical benefit from
participating in this study. Information gained from this research
could lead to improved medical care for children with Bipolar
Disorder. The biggest benefit is that you and your child are
helping other children and adults.
Will I get all the facts about the study?
Parents who are interested in having their child participate will
be given a consent form that thoroughly explains all of the details
of the study. It includes all of the procedures, the risks, the
benefits, who to contact with questions or concerns, and more. A
member of the study staff will review the consent form with you and
will be sure that all of your questions are answered. Study
procedures will not begin until the parent/guardian has signed this
form and, if of age, the child has given at minimum his/her verbal
agreement. What are the risks? It is possible that your child’s
symptoms may not get better, or may become worse while
participating in this study. Also, by participating in this study,
other treatment which could help your child may be delayed.
Children may also feel anxiety, distress, embarrassment and fatigue
from answering questions about their feelings. A previously unknown
problem could result from participation in this study.
What is the compensation?
- There is no pay for participating in this study.
- All participants will receive thorough diagnostic testing, lab
testing, EKG (electrocardiogram), and research monitoring at no
- All participants will receive study medications at no charge
during the study period.
Erin Monroe, MSN, CNS
Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation
Division of Psychiatry, MLC #3014
3333 Burnet Ave.
Cincinnati, OH 45229-3039
If you would like to learn more about participating in this study, please send an email message using the form below.
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