Add-On Ramelteon in Bipolar I Disorder With Clinically Significant Sleep Disturbance

Inclusion Criteria

• •1. Subjects must be 18 to 65 years of age, inclusive.
• •2. Subjects must have lifetime bipolar I disorder as defined by DSM-IV-TR criteria.
• •3. Subjects' manic symptoms must be mild to moderate in severity, defined as an YMRS score between 10 and 25.
• •4. Subjects must be currently experiencing a clinically significant sleep disturbance, defined as a PSQI total score \> 5.
• •5. Subjects must be receiving at least 1 mood stabilizing medication, which may include an atypical antipsychotic (e.g., aripiprazole, clozapine, olanzapine, quetiapine, risperidone, ziprasidone) and/or mood stabilizer/anticonvulsant (e.g, lithium, carbamazepine, valproate/divalproex, lamotrigine, oxcarbazepine) medication for \> 1 week prior to baseline. Continued administration of benzodiazepines or sedative-hypnotics will be allowed only if the subject has been receiving the medication for \> 2 weeks prior to baseline.
• •6. Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained.
• •7. If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least 1 month prior to study entry and throughout the study.