| Secondary efficacy outcomes |
Rates (in percentage) of PANSS total responders Changes in PANSS subscale scores (PANSS positive, PANSS negative, and PANSS psychopathology) Changes in PANSS Marder subscale scores (PANSS Marder positive, PANSS Marder negative, PANSS Marder disorganized thought, PANSS Marder hostility and excitement, and PANSS Marder anxiety and depression) Rates (in percentage) of responders to the Clinical Global Impression–improvement scale (CGI-I) Changes in the Clinical Global Impression–severity scale (CGI-S) Changes in the Negative Symptom Assessment–16 (NSA-16) scale Changes in the Global Assessment of Functioning (GAF) scale Changes in the Brief Psychiatric Rating Scale (BPRS) Time required to achieve a response Time required to achieve remission Duration of time in remission Relapse rates
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| Secondary tolerability outcomes |
Effect on cardiovascular function, such as incidence of QTc prolongation (≥500 ms), changes from baseline in the QTc interval, and orthostasis Effect on weight, such as incidence of clinically significant weight gain (reported as ≥7% increase in body weight from baseline), incidence of clinically significant weight loss (reported as ≥7% decrease in body weight from baseline), and change in weight from baseline Rates of metabolic derangements, such as changes from baseline in fasting blood glucose, changes from baseline in triglycerides, and new-onset metabolic syndrome Incidence of movement disorders, such as incidence of any reported extrapyramidal symptoms, akathisia, and rigidity of any kind; dystonic reactions; and parkinsonism Improvements in several scales that measure extrapyramidal symptoms were also included as secondary tolerability outcomes and include changes from baseline in each of the following scales: Barnes Akathisia Rating Scale (BARS), Simpson Angus Scale (SAS), Extrapyramidal Symptom Rating Scale (ESRS), and Abnormal Involuntary Movement Scale (AIMS). Laboratory changes, such as incidence of hyperprolactinemia, changes from baseline in serum prolactin levels, agranulocytosis, and other reported significant hematologic abnormalities Incidence of neuroleptic malignant syndrome Incidence of anticholinergic effects Effect on sleep Incidence of seizures Behavioural changes, such as incidence of agitation and of anxiety Rates of all-cause mortality
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| Secondary acceptability outcomes |
Patient perspective on efficacy, ease of use, and improvement in quality of life as demonstrated with the use of several scales, including the Glasgow Antipsychotic Side Effect Scale (GASS), Patient Reported Outcomes (PRO), Drug Attitude Inventory (DAI) scale, Personal Evaluation of Transitions in Treatment (PETiT), Quality of Life Enjoyment and Satisfaction (Q-LES-12), Subjective Well-being under Neuroleptic Treatment (SWN) scale, and the physical and mental component scales of the Medical Outcomes Study 12-item Short Form (SF-12) Adherence rates Rates of all-cause discontinuation Rate of discontinuation due to adverse effects or a lack of efficacy Time to admission and readmission to hospital Length of stay in hospital Patient’s reintegration into society (and/or workforce) Patient engagement in services Cost-effectiveness, including cost to the patient as well as the health care system
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| Post hoc outcomes |
Incidence of any adverse drug reaction Incidence of severe adverse effects Changes in aspartate aminotransferase Changes in alanine aminotransferase
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