Bipolar I Depression Clinical Trial

Overview
The purpose of this research study is to see how an Investigational Drug affects symptoms of bipolar depression. The term Investigational Drug means that it is not yet approved to be sold; it can only be used for testing. Therefore, the investigational drug must be further tested in people to make sure that it works and is safe.

To be eligible for this study, you must:

• be Diagnosed with Bipolar I Disorder
• be currently depressed
• be 18 to 65 years of age
• be willing to go off medication, or you must not be currently taking medication for bipolar disorder
• have a prior history of illness with two or more manic or mixed episodes and at least one of these episodes has documented pharmacological treatment for manic symptoms
• not be currently experiencing a manic or mixed episode
• not be currently abusing drugs or alcohol

If you are eligible for this research study, you will be in the research study for up to 16 weeks:

• Screening period of up to 4 weeks,
• 8 weeks of research study drug treatment with weekly visits
• 4 week follow-up visit

There will be a total of 11 scheduled visits. Each visit will last approximately 2 hours, however the screening visit may last 3-4 hours.

All research study-related procedures and any research study medication will be provided at no cost to you. If you complete all research study visits, you will receive a total of $350.