Trial Information

Summary: A Two-Week, Double Blind, Placebo Controlled, Randomized, Parallel Group, Efficay and Safety, Out Patient Trial With XXX in Patients With Chronic Primary Insomnia.

Patient Inclusion Criteria

• Able to provide informed consent
• Male or female, at least 18 years of age and the age of legal consent at the time of consent.
• Lifetime history of at least one bipolar manic or mixed episode
• Onset of Bipolar I depressive episode within ≥2 weeks and ≤6 months.

Patient Exclusion Criteria

• Attempted suicide within 3 months prior to Screening
• Pregnant or breast feeding at Screening or intend to become pregnant during the trial.
• History of seizures (except febrile seizures of childhood) or epilepsy or are taking an anticonvulsant medication to prevent seizures.
• Had a seizure related to drug withdrawal within the past 6 months.
• History of significant cardiovascular disease or significant concurrent cardiovascular disease, including uncontrolled hypertension
• Participated in a clinical trial with an investigational drug or device in the 30 days prior to Screening.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.