Summary:
A clinical research study examining the safety and effectiveness of various doses of ramelteon (TAK-375), the investigational drug, compared to placebo in people who have Bipolar I disorder.
Results from earlier trials showed patients with Bipolar I disorder may have been less likely to become depressed or manic while taking TAK-375.
Qualified Participants Must:
Be between 18 and 75 years of age
Suffer from Bipolar I disorder, with the most recent episode leading to depression
Be willing to make study visits (up to 9 visits)
Qualified Participants May Receive:
Study medication
, $50 stipend for each visit
, free medical exams as required for study
, 3 months of free follow-up care with doctors after study is complete.