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First- and Second-Generation Antipsychotics for Children and Young Adults

Slide: 16 of 43

Summary of Study Characteristics Evaluated in the Effectiveness Review: PICOTS

Development of clinical studies of effectiveness of medical interventions is guided by the PICOTS (population, interventions, comparators, outcomes, timing, and setting) framework. These items are critical elements that will help to answer important clinical questions. In the comparative effectiveness review, the clinical study literature was reviewed and summarized by using the PICOTS framework. The evidence concerning the outcomes identified here was examined in detail, and strength-of-evidence determinations were made only for the key outcomes (see below).

Population: Children to age 12 years, adolescents ages 12–17 years, and young adults ages 18–24 years with these diagnosed mental disorders: PDD, ADHD, DBD, bipolar disorder, schizophrenia or related psychosis, Tourette’s syndrome, or other behavioral symptoms

Interventions: Any FDA-approved FGAs and SGAs

Comparators: Other FGAs or SGAs, placebo

Outcomes: Core and nonspecific symptoms; response; remission; growth and maturation; cognitive and emotional development; suicide-related behaviors; adherence; school and work capacity and performance; patient insight; patient-, parent-, or caregiver-reported outcome; health-related quality of life; legal system interaction; health care system utilization; adverse events (e.g. weight; dyslipidemia; insulin and blood glucose effects and diabetes; extrapyramidal symptoms; prolactin effects)

Timing: No minimum or maximum duration specified

Setting: Community and hospitalized care

Abbreviations: ADHD = attention deficit hyperactivity disorder; DBD = disruptive behavior disorder; FDA = U.S. Food and Drug Administration; FGAs = first-generation antipsychotics; PDD = pervasive developmental disorder; SGAs = second-generation antipsychotics