Bipolar Disorder Clinical Trial
Official title:
A Double-Blind, Randomized, Placebo-Controlled Trial of Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder.
The purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.
Patients with euthymic bipolar disorder, although free of significant mood symptoms, often
have continued sleep disturbances. Improving patients' sleep by also normalizing the
circadian rhythm will lead to fewer mood exacerbations. Ramelteon offers a new and more
pharmacologically exact mechanism to re-synchronize the SCN. The administration of ramelteon
for bipolar patients will improve sleep and will cause fewer mood exacerbations.
Patients with bipolar disorder often experience frequent mood alterations that are attempted
to be controlled by mood stabilizing agents and anti-psychotic agents. Both classes of
medications have numerous significant side effects. Establishing that ramelteon is helpful
in the sleep of patients with bipolar disorder and helpful in mood stability will increase
the number of treatment options for bipolar patients.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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