This study is designed with the aim to evaluate the clinical effect of the overlapped switching to ziprasidone as well as the efficacy and safe metabolic profile of ziprasidone.
Patients with schizophrenia or schizoaffective disorder were recruited in this 12-week, multicenter, non-comparative, open-label trial. Prior antipsychotics were allowed to be maintained for up to 4 weeks during the titration of ziprasidone. Efficacy was primarily measured using the 18-item Brief Psychotic Rating Scale (BPRS) at baseline, 4 weeks, 8 weeks, and 12 weeks. Efficacy was secondarily measured by the Clinical Global Impression - Severity (CGI-S) scale and the Global Assessment of Functioning (GAF) scale at each visit. Regarding the metabolic effects of switching to ziprasidone, weight, body mass index (BMI), waist-to-hip ratio (WHR), and lipid profile-including triglyceride (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and total cholesterol levels-were measured at each follow-up visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
100% of the past antipsychotic dose will be maintained in week 1, using flexible dosing of 0-100% during next 3 weeks and then discontinued. Ziprasidone will be maintained with flexible dosing of 40-160mg/day during the study period.
Korea University Medical Center Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
Inha University Hospital
Incheon, South Korea
Catholic University Our Lady of Mercy Hospital
Incheon, South Korea
A change in the Brief Psychotic Rating Scale (BPRS)
Time frame: baseline and 12 weeks
A change in the Lipid profile (Triglyceride, HDL, LDL, Total cholesterol)
Time frame: baseline and 12 weeks
A change in the Body Mass Index (BMI)
Time frame: baseline and 12 weeks
A change in the Waist-to-hip ratio
Time frame: baseline and 12 weeks
UKU side effect rating scale - patient (UKU-SERS-Pat)
Time frame: baseline
UKU side effect rating scale - patient (UKU-SERS-Pat)
Time frame: 4 weeks
UKU side effect rating scale - patient (UKU-SERS-Pat)
Time frame: 8 weeks
UKU side effect rating scale - patient (UKU-SERS-Pat)
Time frame: 12 weeks
A change in the Clinical Global Impression (CGI)
Time frame: Baseline and 12 weeks
A change in the Global Assessment of Functioning (GAF)
Time frame: Baseline and 12 weeks
Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein
Time frame: Baseline
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Korea University Medical Center Guro Hospital
Seoul, South Korea
Kangnam Sacred Heart Hospital
Seoul, South Korea
Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein
Time frame: 12 weeks
Urinalysis
Time frame: Baseline
Urinalysis
Time frame: 12 weeks
Electrocardiogram (ECG)
Time frame: Baseline
Electrocardiogram (ECG)
Time frame: 12 weeks