Study to compare the efficacy of ziprasidone (Zeldox) and aripiprazole (Abilify) on cognitive functioning and quality of sleep in the treatment of schizophrenic patients
- Conditions
- Schizophrenia
- Registration Number
- EUCTR2005-004501-28-DE
- Lead Sponsor
- Department of Psychiatry, Ludwig-Maximilians-University Munich
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
-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
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Comparison of the efficacy of ziprasidone and aripiprazole on cognitive functioning and quality of sleep<br>;Secondary Objective: Mean change from baseline in PANSS (Positive and Negative Symptom Scale) total-Score<br>Mean change from baseline in CGI (Clinical Global Impression) Score<br>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%) <br>Assessment of the patients satisfaction with antipsychotic treatment by DAI questionnaire<br>Assessment of the patients quality of life by SF-36 questionnaire<br>;Primary end point(s): clinical efficacy of both neuroleptics with regard to cognitive functioning (test battery of cognitive functions) and quality of sleep
- Secondary Outcome Measures
Name Time Method