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CNS Clinical Trials: Suicidality and Data Collection - Workshop Summary
typical RCT with its strict inclusion and exclusion criteria. RCT patients are typically in better health and have fewer comorbidities than real-world patients. The study sought to find out how patients fared over the long term with depression treatment; its focus was on patients who are hard to treat, considering that the majority of depressed patients do not respond significantly enough to the first antidepressant they try (Little, 2009). It also sought to identify the comparative effectiveness of the several tiers of pharmacological therapies. The trial was conducted in a network of primary and specialty care settings across the country. Simply put, its goal was to help practicing clinicians sort out treatment recommendations in everyday practice. Until now, no studies have given guidance essential for patient management over the course of antidepressant treatments. With nearly 20 medications to choose from, this is no easy feat.
Formally known as Star*D, the Sequenced Treatment Alternatives to Relieve Depression trial used a common set of outcome measures, including one three-part question covering suicidal ideation and behavior, which was the centerpiece of Trivedi’s presentation. The longitudinal nature of this study and its real-world setting helped his team discern the evolution of suicidal ideation into suicidality. That path rarely has been traced because such patients with ideation are normally excluded from clinical trials.
Suicidal ideation and suicidality were measured by a three-part question of the QIDS questionnaire (Quick Inventory of Depressive Symptomatology—Self-Report); (Zisook et al., 2009). The level of severity ranges from 0 to 3 (Box 4-1), with a score of 1 meeting the definition of mild suicidal ideation and 3 meeting the definition of a suicidal attempt. Designed as an open trial, there was no comparison group, so patients were assessed in relation to their baseline visit.
Question About Suicidal Ideation in the Quick Inventory of DepressiveSymptomatology—Self-Report
Thoughts of death or suicide:
I do not think of suicide or death.
I feel that life is empty or wonder if it’s worth living.
I think of suicide or death several times a week for several minutes.
I think of suicide or death several times a day in some detail or I have made specific plans for suicide or have actually tried to take my life.