Columbia-Suicide Severity Rating Scale Sample Clauses

Columbia-Suicide Severity Rating Scale. An evaluation for suicidality will be administered directly to the patient using IRT. (ERT), at baseline and at each visit during the treatment period using the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS Baseline version will be performed at baseline (visit 2) and the C-SSRS since Last Visit version will be performed at visits 4 through 16 (or final assessment visit). If the C-SSRS is positive at any visit during the treatment period, the patient will be evaluated by the investigator to determine if a formal evaluation by a trained mental health professional is indicated. If the patient is determined to be a risk to himself or herself or others, the sponsor will be notified and the patient will be withdrawn from the study.

Columbia-Suicide Severity Rating Scale. Suicidality data collected on the C-SSRS at baseline and by visit during the Treatment Period will be listed for all subjects. Listings will include behavior type and/or category for Suicidal Ideation and Suicidal Behavior of the C-SSRS.