Schizophrenia Clinical Trial
Background: Surveys have shown that antipsychotic drug combinations are frequently
prescribed. Amisulpride, an atypical antipsychotic agent, has low incidence of
extrapyramidal symptom (EPS) but with high cost compared to sulpiride. The objective of the
study is to compare the efficacy and safety of the 800-mg/d amisulpride and 400-mg/d
amisulpride plus 800-mg sulpiride in the treatment of acute psychotic exacerbations of
schizophrenia.
Method: In this 6-week, double-blind, fixed-dose study, patients with schizophrenia are
randomly assigned to amisulpride (800 mg/d) or amisulpride (400 mg/d) plus sulpiride (800
mg/d).The hypothesis is that the two treatment groups have the similar efficacy and safety,
but different cost.
Background: Antipsychotic monotherapy is recognized as the treatment of choice for patients
with schizophrenia. Surveys have shown that antipsychotic drug combinations are frequently
prescribed, yet few clinical studies have examined this practice. Amisulpride, an atypical
antipsychotic agent, has low incidence of extrapyramidal symptom (EPS) but with high cost
compared to sulpiride. It has been reported that mean doses of low-potency typical
antipsychotics less than 600 mg/day of chlorpromazine equivalent dose has no higher risk of
EPS than atypical antipsychotics. The objective of the study is to compare the efficacy and
safety of the 800-mg/d amisulpride and 400-mg/d amisulpride plus 800-mg sulpiride in the
treatment of acute psychotic exacerbations of schizophrenia.
Method: In this 6-week, double-blind, fixed-dose study, patients with schizophrenia (DSM-IV
diagnosis) are randomly assigned to amisulpride (800 mg/d) or amisulpride (400 mg/d) plus
sulpiride (800 mg/d). The hypothesis is that the two treatment groups have the similar
efficacy and safety, but different cost. The efficacy assessment was the change from
baseline in the score on the Clinical Global Impression-Severity (CGI-S), Positive and
Negative Syndrome Scale (PANSS) and subscales (positive scale, negative scale, general
psychopathology scale), Calgary Depression Scale for Schizophrenia (CDSS), and Global
Assessment of Functioning (GAF). Safety assessments include the change from baseline on
Simpson-Angus Rating Scale (SAS), Abnormal Involuntary Movement Scale (AIMS), Barnes
Akathisia Scale (BAS), and UKU Side-effects Rating Scale (UKU), and the change from baseline
in prolactin levels, body weight, vital sign, blood pressure, AC glucose level, and lipid
profiles(cholesterol, high density lipid protein [HDL], low density lipid protein [LDL], and
triglyceride [TG]).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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