A study of a new formulation of ramelteon, in combination with lithium or valorate, in the treatment of acute depressive episodes in adults with bipolar I disorder.

The purpose of this study is to determine if a new formulation of ramelteon is effective in decreasing the symptoms of depression during an acute depressive episode associated with bipolar I disorder. This is a placebo controlled study and treatments will be randomly assigned. Three hundred subjects from North America are expected to participate in this study, and we expect to enroll 20 subjects at Rush University Medical Center. This study consists of nine office visits over nine weeks.

You may be eligible to participate in this study if you:

• Have been diagnosed with bipolar I disorder
• Are currently taking lithium and/or valporate
• Are currently experiencing depressive symptoms
• Are between the ages of 18 to 75

You will be excluded from this study if you:

• Are abusing drugs and/or alcohol
• Have used of ramelteon in the past
• Have any history of fibromyalgia, chronic fatigue syndrome, chronic pain syndrome or sleep apnea
• Are a female who is pregnant or nursing

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.