Trial Information

Summary: A Six Week, Double Blind, Multicenter, Placebo Controlled Study Evaluating the Efficacy and Safety of Flexible Doses of Oral XXXX as Add-On, Adjunctive Therapy with Lithium, Valproate or Lamotrigine in Bipolar I Depression

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.
• Primary diagnosis of Bipolar I Disorder, most recent episode depressed
• Onset of Bipolar I depressive episode within ≥2 weeks and ≤6 months.

Patient Exclusion Criteria

• Comorbid DSM-IV TR Axis I or Axis II disorder that is clinically unstable, requires treatment, or has been a primary focus of treatment within the 6 month period prior to Screening.
• 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.
• 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.