Research Study for Children and Teens with Bipolar Mania
What is the purpose of this study?
This is a research study to evaluate the effectiveness of a medication, lithium, in the treatment of children with bipolar I disorder (also known as bipolar mania). The study drug was chosen because it has been successful in the treatment of bipolar disorder in adults.
Who can participate?
Children and teens 7 to 17 years old who have been diagnosed with bipolar I disorder and are currently experiencing manic symptoms may be eligible to participate in the study.
Ages
Conditions
- Medications
- Mental Health
- Psychiatry
What is involved?
Participants will be involved in the study for a minimum of eight weeks and nine study visits. The study may last for a maximum of 68 weeks (17 months) and 41 study visits. Participants’ time in the study will be determined on an individual basis according to how they respond to the study medication.
The study is broken up into four separate phases:
Phase 1 (8 weeks) During phase 1, participants will be randomized (put into one of two treatment groups by chance, like flipping a coin) to receive either the study medication or a placebo (a “dummy” medication) for 8 weeks. There is a 66% chance participants will receive the study medication and a 33% change they will receive the placebo. This study is double-blind, which means that the participants, the study doctor, nor the study staff knows which substance participants receive; however, this information is available to the study doctor in the event of an emergency. Participants whose symptoms partially improve during phase 1 may be asked to move on to phase 2.
Participants who do not see any change in symptoms or whose symptoms worsen during phase 1 will not be able to enter phase 2 and will be withdrawn from this study. However, participants who receive placebo during phase 1 and have no response or partial response to placebo can receive up to 24 weeks of the study medication.
Phase 2 (24 weeks) During phase 2, all participants will receive the study drug for up to 24 weeks. Participants who have had no mood or behavior symptoms for six consecutive weeks within the last eight weeks of phase 2 may be able to continue to phase 3.
Participants who have symptoms during the final two weeks of phase 2 or have had symptoms for three of the final eight weeks of phase 2 will not be able to enter phase 3 of the study and will be withdrawn from the study.
Phase 3 (28 weeks) During phase 3, participants will be randomized to receive either the study medication or placebo for up to 28 weeks. There is a 50% chance participants will receive the study medication and a 50% change they will receive the placebo.
Participants who are chosen to receive placebo will be taken off the study drug and put on placebo in a slow manner determined by the study doctor. Only participants whose symptoms worsen during phase 3 may be enrolled in phase 4.
Phase 4 (8 weeks) During phase 4, all participants will receive the study drug for up to 8 weeks.
Many of the same tests and procedures will be repeated throughout the study. These include, but are not limited to:
- Psychological interviews to evaluate if potential participants meet study criteria
- Assessments and questionnaires to determine severity of symptoms
- Health and medication history
- Physical exam, including height and weight, temperature, pulse, and blood pressure measurements
- ECG (electrocardiogram) to record the electrical activity of the heart
- Fasting (8 hours without food/only water) blood and urine tests
- Pregnancy test (for females of child bearing potential)
- Drug testing
A detailed list of tests and procedures will be provided to those interested in knowing more about this study.
What are the benefits?
Participants may or may not benefit from participating in this study. Potential benefits include careful monitoring and frequent visits with the doctor. Participating in the study could help produce information that would help other children with bipolar disorder in the future.
Will I get all the facts about the study?
Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the potential risks and benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with participants to ensure all questions are answered. Study procedures will not begin until a parent/guardian has signed this consent form and, if of age, the child has given at minimum his/her verbal consent.
Do participants receive pay, compensation or reimbursement?
Participants will receive payment for time and travel. Participants will receive $40 for each completed visit.
Who should I contact for more information?
Twila Rogers
Clinical Research Coordinator IV
(513) 636-0160
Division of Child and Adolescent Psychiatry
Cincinnati Children’s Hospital Medical Center
3333 Burnet Avenue
Cincinnati, OH 45229-3039
twila.rogers@cchmc.org
Principal Investigator
Robert A. Kowatch, MD
Principal Investigator
Division of Child and Adolescent Psychiatry
Cincinnati Children’s Hospital Medical Center
Date
Ongoing
