Schizophrenia
Conditions
Interventions
Trade Name: Zeldox 80mg
Product Name: Ziprasidone
Pharmaceutical Form: Capsule*
INN or Proposed INN: Ziprasidon
Concentration unit: mg milligram(s)
Concentration number: 80-
Trade Name: Abilify 10mg
Sponsors
Department of Psychiatry, Ludwig-Maximilians-University Munich
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with diagnosis of schizophrenia according to the DSM-IV criteria (295.x) - patients in need of a switch of antipsychotic medication due to side effects or lack of efficacy - both male and female patients, aged 18 to 65 years - provision of written informed consent - women of childbearing potential must be using a reliable method of contraception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - risk of suicide or aggressive behaviour - need of additional antipsychotic drug treatment other than study drug after randomisation - treatment with antidepressants - diagnosis of substance abuse or dependence within the last three months prior to baseline according to the DSM-IV criteria (305.xx) - organic CNS disease, history of psychosurgery - pregnancy or lactation - participation in any drug trial within the last 30 days prior to baseline - known HIV infection, hepatitis B or C, cancer - elevation of bilirubin, GOT or GPT of more than one standard deviation beyond the reference range - Leukopenia - known idiopathic or medication-induced agranulocytosis - known intolerance of ziprasidone or aripiprazole - known QT-prolongation - congenital QT-syndrome - recent myocardial infarct - uncompensated cardiac insufficiency - heart rhythm disturbance treated with antiarrhythmic medication class IA and III - concomitant treatment with medicinal products leading to QT-prolongation as antiarrhythmic medication class IA and III, Arsentrioxid, Halofantrin, Levomethadylacetat, Mesoridazin, Thioridazin, Pimozid, Sparfloxazin, Gatifloxazin, Moxifloxazin, Dolasetronmesilat, Mefloquin, Sertindol or Cisaprid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of the efficacy of ziprasidone and aripiprazole on cognitive functioning and quality of sleep ;Secondary Objective: Mean change from baseline in PANSS (Positive and Negative Symptom Scale) total-Score Mean change from baseline in CGI (Clinical Global Impression) Score Percentage of responders (defined by a score of 1 or 2 in CGI improvement or a reduction of the PANSS total Score of at least 30%) Assessment of the patients satisfaction with antipsychotic treatment by DAI questionnaire Assessment of the patients quality of life by SF-36 questionnaire ;Primary end point(s): clinical efficacy of both neuroleptics with regard to cognitive functioning (test battery of cognitive functions) and quality of sleep | — |
Countries
Germany
Outcome results
None listed