Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial
Phase 4
Completed
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Registration Number
- NCT00224315
- Lead Sponsor
- Central Institute of Mental Health, Mannheim
- Brief Summary
We aim to compare the augmentation of clozapine with ziprasidone or risperidone in a randomized, prospective manner.
- Detailed Description
Partial response of schizophrenic psychoses to a monotherapy with clozapine is a frequent problem of clinical psychiatry. Current problems are treatment resistant positive and/or negative symptoms, as well as side effects. Therefore, different strategies of augmentations have been applied. Based on successful experiences in case reports and results of other work groups, we aim to compare the augmentation of clozapine with ziprasidone or risperidone in a randomized, prospective manner.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Treatment resistant schizophrenic or schizoaffective disorder under therapy with clozapine,
- Age between 18 and 70,
- Informed consent
Exclusion Criteria
- No informed consent,
- Intolerance with respect to ziprasidone or risperidone,
- Contraindications with respect to these substances,
- Gravidity or missing anticonceptive safety
- Substance dependance (excluded nicotin)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method PANSS, SANS, HAMD, GAF, CGI, QTc
- Secondary Outcome Measures
Name Time Method Body weight, EPMS, Akathisia,Prolactin, blood pressure, heart rate
Trial Locations
- Locations (1)
Central Institute of Mental Health, Department of Psychiatry,
🇩🇪Mannheim, BW, Germany