Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Schizophrenia, Schizoaffective Disorder, Ziprasidone, Switch, Metabolic syndrome
Brief summary
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.
Detailed description
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.
Interventions
DRUGZiprasidone
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.
Sponsors
Pfizer
Soonchunhyang University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male and female aged 18-55 years treated with risperidone, olanzapine, amisulpride, quetiapine and typical antipsychotics. * Both in- and outpatients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for schizophrenia or schizoaffective disorder. * Their primary psychiatric clinician determined that they would benefit from a change in their medications, either because of suboptimal efficacy or because of side effects.
Exclusion criteria
* Those who are treated with medications that prolong the QTc interval. * Those who have any other axis I DSM-IV diagnoses. * Those who have a history of substance abuse or dependence within 1 month. * Those who have clinically significant abnormal laboratory values or any other abnormal baseline laboratory findings considered by psychiatrists to be indicative of conditions that might affect the study results. * Those who have a past history of hypersensitivity or intolerance to ziprasidone. * Those who have history of clozapine use within 1 month. * Those who participated in clinical trials within 1 month before entering the study entry. * Those who have used depot antipsychotics within one cycle before entering the study. * Those who are pregnant or are breast feeding. * Those who have a immediate risk of harming self or others or history of suicide attempts in the year before the screening precluded inclusion in the study. * The patients unable/unlikely to comprehend/follow the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A change in the Brief Psychotic Rating Scale (BPRS) | baseline and 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| A change in the Body Mass Index (BMI) | baseline and 12 weeks |
| A change in the Waist-to-hip ratio | baseline and 12 weeks |
| UKU side effect rating scale - patient (UKU-SERS-Pat) | baseline |
| A change in the Clinical Global Impression (CGI) | Baseline and 12 weeks |
| A change in the Lipid profile (Triglyceride, HDL, LDL, Total cholesterol) | baseline and 12 weeks |
| Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein | Baseline |
| Urinalysis | Baseline |
| Electrocardiogram (ECG) | Baseline |
| A change in the Global Assessment of Functioning (GAF) | Baseline and 12 weeks |
Countries
South Korea
Outcome results
None listed