University of Cincinnati studies bipolar disorder in youth

The University of Cincinnati is conducting a research study aimed at evaluating the effectiveness and safety of a medication currently approved for adults in treating children and teens aged 10 to 17 years who have bipolar disorder and are experiencing a major depressive episode (MDE). This study seeks to gather essential data that could inform future treatment options for young individuals facing this mental health challenge.

### Eligibility for Participation Children and adolescents between the ages of 10 and 17 with a diagnosis of bipolar I or II disorder and currently undergoing an MDE may qualify for this study. Participants will go through a screening process to confirm their eligibility, which includes a review of their medical history and current medication use.

### Study Structure The study will involve up to nine visits to the research center over a two-month period. During these visits, various assessments will take place to determine the most effective treatment strategies for this age group. Participants will be randomly assigned to one of two groups: one group will receive the study medication, while the other will receive a placebo. This randomization process ensures that results can be accurately compared.

Participants have a 50% chance of receiving the study drug, which aims to assess its impact on their condition. If a participant is currently taking medications that are not permitted during the study, they will need to gradually discontinue those medications under a physician’s supervision.

### Key Procedures Throughout the study, participants will undergo several procedures, which include: – **Fasting** overnight for at least eight hours before visits when blood or urine samples will be collected, except during the initial screening visit. – **Physical examinations** conducted by the study doctor, including measurements of vital signs, height, and weight. – **Electrocardiograms (ECG)** to monitor heart activity. – **Blood tests** to assess overall health and check for infections, as well as to evaluate how the study drug affects their body. – **Urine tests** and **breathalyzer tests** to check for alcohol consumption. – **Questionnaires and interviews** with both the participant and their parent or guardian, to gather additional insights on their health and treatment experience. – For participants who menstruate, a menstrual calendar will be maintained, and pregnancy tests will be conducted. – Participants who are sexually active must agree to use an effective method of birth control for the duration of the study.

### Parental Involvement Parents or guardians will play a vital role in monitoring the administration of the study drug, which is to be taken once daily in the evening. The study team will provide guidance on how to properly administer the medication. Prior to the study’s commencement, a detailed consent form will be shared with the parent or guardian, explaining all aspects of the study, and answering any questions they may have.

### Outcomes and Compensation While there are no guarantees that participants will benefit from the study, the information gathered may advance understanding of major depressive episodes in young individuals with bipolar disorder, potentially leading to improved future treatments. Participants may receive compensation for their time and travel during the study.

### Contact Information For more details about the study, interested families can reach out to Dr. Melissa DelBello at the University of Cincinnati’s College of Medicine, Department of Psychiatry and Behavioral Neuroscience.