11. Patients with the following mood disorders as judged by the Investigator or a psychiatrist, or as a result of patient's mood assessment questionnaire: Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicide/homicidal ideation (immediate risk of doing harm to others)) or patients with active severe personality disorders (defined according to DSM- IV) are not eligible. Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug. ≥CTCAE Grade 3 anxiety, Meets the cut-off score of ≥ 10 on the 9-item Patient Health Questionnaire (PHQ-9) or a cut-off score of ≥15 on the 7-item, Generalized Anxiety Disorder (GAD-7) mood scale, or who selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) will be excluded from the study unless overruled by the psychiatric assessment.