Trial Information

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:

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 evaluation
Treatment phase - 7 weekly visits lasting approximately 30 minutes each:
- 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 in health
- 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.

What are the benefits?

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 charge.
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
Phone: 513-636-1007
Email: erin.monroe@cchmc.org

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Research Center Information: Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation

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