Clinical effectiveness of the newer antipsychotic compounds olanzapine, quetiapine and aripiprazole in comparison with low dose conventional antipsychotics (haloperidol and flupentixol) in patients with schizophrenia
Phase 4
- Conditions
- F20Schizophrenia
- Registration Number
- DRKS00000304
- Lead Sponsor
- niversität BremenKompetenzzentrum für Klinische Studien Bremen, Biometrie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 149
Inclusion Criteria
Patients with schizophrenia, age 18-65, necessity to establish new or change antipsychotic treatment due to unsatisfying results or side effects.
Exclusion Criteria
Acute suicidal tendency, Einwilligungsvorbehalt (BGB) or Unterbringung (PsychKG), organic psychosis, history of malignant neuroleptic syndrome, QTc interval greater than or equal to 0.5 s / history of congenital QTc prolongation.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two primary efficacy endpoints used in the study. 1) Quality of life from the patient's perspective with SF-36 (interviewer version with a time frame of one week) and 2) the change in clinical status from the perspective of the investigator with CGI. The change from baseline at week 24 is measured by AUC based on logarithmic transformed time scale.<br>
- Secondary Outcome Measures
Name Time Method Secondary endpoints:<br>Subscores of SF-36, SWN-K, PSP, PANSS, CGI-Matrix (treatment response).<br><br>Assessment of safety:<br>Adverse events, drop-out rates, SAS / AIMS / BARS and sexual dysfunction changes. Metabolic side effects: body mass index (BMI), waist circumference, HbA1c, fast blood glucose levels, lipid profile changes (total cholesterol / LDL cholesterol /HDL cholesterol, triglycerides) from baseline to week 24 (visit 6), serum concentration of the respective study drug (olanzapine, quetiapine, aripiprazole, haloperidol, flupentixol).