Schizophrenia, Schizoaffective Disorder
Conditions
Keywords
Schizophrenia,, schizoaffective disorder,, treatment resistancy, clozapine,, ziprasidone, risperidone, combination
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.
Interventions
DRUGziprasidone
DRUGrisperidone
Sponsors
Central Institute of Mental Health, Mannheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PANSS, SANS, HAMD, GAF, CGI, QTc | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight, EPMS, Akathisia,Prolactin, blood pressure, heart rate | — |
Countries
Germany
Outcome results
None listed