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Bipolar Maintenance Study


Start Date: 1/12/2009
Contact: Gregory Carlson, (631) 632-8828
Study Type:
Principal Investigator: Gabrielle Carlson, MD

Trial:
We are enrolling students, ages 10-17, with BIPOLAR I DISORDER in a clinical research study. This study will assess the safety and effectiveness of an investigational medication versus placebo (substance which contains no active medication) when added to conventional bipolar medications. The investigational study medication is currently approved by the Food and Drug Administration for use in adults with bipolar I disorder. Participants in this study may be able to continue on their current bipolar medications.

Approximately 340 children and teens will participate in this study at approximately 46 research centers in the United States. Participation requires attending regular study visits, oftentimes weekly, at Stony Brook University's Child Psychiatry Outpatient Department, over a period of approximately one year.

Study participants must be:
10 -17 years old.
Diagnosed with bipolar I disorder.
Currently on a stable regimen of bipolar medication(s), but still experiencing symptoms.
Study Participants May Receive, at No Cost:
Study specific medical care including comprehensive psychiatric evaluations.
Investigational study medication
Compensation for time and travel
At all times, the participant’s information will remain confidential.
The study is being funded by Glaxo-Smith-Kline.

For further information, please contact Gregory Carlson at 631-632-8828.

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