Clonidine: een veelbelovende toevoeging aan de huidige behandeling van schizofrenie.
- Conditions
- Therapy resistant schizophreniaClonidineNoradrenaline
- Registration Number
- NL-OMON20882
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 75
Inclusion Criteria
1. A DSM-IV-R diagnosis of: 295.x (schizophrenia, schizophreniform disorder, or schizoaffective disorder)
2. No or only partial response to clozapine as defined by a total PANSS score of at least 80.
Exclusion Criteria
1. Presence of any of the contra-indications of clonidine as reported in the Summary of Product Characteristics (SPC).
2. Supine systolic blood pressure (SSBP) < 85 mm HG
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Positive and Negative Symptom Scale (PANSS) total compared to baseline.
- Secondary Outcome Measures
Name Time Method -General functioning (tested by Global Assessment of Functioning, GAF)<br /><br>-Cognitive functioning (tested by Brief Assessment in Cognition, BACS and The Cambridge Neuropsychological Test Automated Battery, CANTAB) <br /><br>-Depressive symptoms (tested by Calgary Depression Scale For Schizophrenia, CDSS) <br /><br>-Safety data will be evaluated by comparing incidences (number and percentage of subjects with at least one occurrence) of key SEAs and SUSARs (e.g. hospitalizations) <br /><br>-Psychophysiological parameters (tested by Copenhagen Psychophysiological Test Battery, CPTB)