Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II.

Exclusion Criteria

• •1. Current diagnosis of schizophrenia, dementia, intellectual disability, organic mental disorder (by clinical assessment). Comorbidity with other psychiatric disorders (personality disorders, anxiety disorders, substance use disorders, eating disorders, and attention deficit disorder) will be permitted provided the primary diagnosis is bipolar disorder;
• •2. acute suicidal ideation (defined by HAMD-17 item 3 ≥ 3 points or by clinical assessment);
• •3. current depressive episode with psychotic features (by clinical assessment);
• •4. suspected or confirmed pregnancy;
• •5. severe or unstable clinical illnesses;
• •6. previous history of non-response to an adequate course of at least 8 sessions of electroconvulsive therapy;
• •7. previous history of non-response to an adequate course of ketamine treatment.