Schizophrenia Clinical Trial
Official title:
Comparative Efficacy of Amisulpride vs Risperidone on Cognitive Functions in Patients With Chronic Schizophrenia
Primary objectives
- To compare neurocognitive effects of amisulpride with those of risperidone in patients
with chronic schizophrenia, as assessed by the general cognitive index, a measure of
overall cognitive functioning in schizophrenia
Secondary objectives
- Secondary analyses will be conducted to determine how the two atypical agents'
neurocognitive effects compare with regard to their profile of therapeutic action
(based on individual cognitive domain scores in seven cognitive domains, including
speed of processing, attention/vigilance, working memory, verbal learning and memory,
visual learning and memory, reasoning and problem solving and social cognition);
- Investigate whether amisulpride elicits more improvement on negative symptoms compared
to risperidone treatment, as measured by the total score on the Scale of the Assessment
of Negative Symptoms (SANS) 8 and by the Negative Symptom Subscale of the Positive and
Negative Symptom Scale (PANSS);
- Assess whether amisulpride improves overall functioning and individual domains of
psychotic symptoms compared to risperidone as measured by the Clinical Global
Impression (CGI), and the total and positive and general psychopathology subscale
scores of PANSS and by the individual domains of SANS, respectively;
- Evaluate the safety and tolerability of amisulpride and risperidone based on the study
completion rates, and frequency of abnormal laboratory values, prolactin serum
concentrations and on the Simpson Angus Scale for Extrapyramidal Symptoms (SAS) 10 and
the Abnormal Involuntary Movement Scale (AIMS).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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