ECT is effective as treatment of psychosis in patients suffering from clozapine resistant schizophrenia.
ID
Bron
Verkorte titel
Aandoening
psychosis, schizophrenia, clozapine, electroconvulsive therapy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Positive symptoms score on the Positive and Negative syndrome scale (PANSS)
Achtergrond van het onderzoek
In the Netherlands electroconvulsive therapy (ECT) is mainly used for treatment of depression. The ECT guidelines from the Nederlandse Vereniging van Psychiatrie (NVVP 2000) broaden the use of ECT. These guidelines recommend the use of ECT for treatment of schizophrenia when an adequate treatment with clozapine has not been efficacious. There is however little evidence for the efficacy of ECT in clozapine resistant schizophrenia. In this study the efficacy of ECT in the treatment of schizophrenia is explored in patients who are still suffering from psychosis despite adequate treatment with clozapine. Patients are randomized in two groups. In the control group patients continue treatment with clozapine. In the treatment group patients receive ECT treatment and clozapine is also continued. The primary outcome criterion is the reduction in positive symptoms of schizophrenia, which is assessed using the Positive and Negative Syndrome Scale (PANSS). In the follow up phase the time to relapse after a successful ECT course is explored. A single blind, prospective, randomized, controlled study design is used.
Doel van het onderzoek
ECT is effective as treatment of psychosis in patients suffering from clozapine resistant schizophrenia.
Onderzoeksopzet
Baseline, two weeks, four weeks, six weeks (end point)
Onderzoeksproduct en/of interventie
Clozapine vs. clozapine + ECT
Publiek
St Jorisweg 2
O. Nielsen
Delft 2612 GA
The Netherlands
+31 (0)15 2607651
Wetenschappelijk
St Jorisweg 2
O. Nielsen
Delft 2612 GA
The Netherlands
+31 (0)15 2607651
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age: 18 yrs or older
2. Suffering from schizophrenia
3. Able to give informed consent
4. Treatment with clozapine for at least eight weeks with blood levels of at least 350 ng/ml has been shown to be inadequate
5. Inadequate treatment is defined as a score of at least 4 on 2 of the 4 psychotic items (paranoia, delusions, hallucinations, formal thought disorder) of the Brief Psychiatris Rating Scale (BPRS)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Contra-indication for ECT: myocardial infarction less than 3 months old
2. Drugs or alcohol abuse less than a month ago
3. Clozapine blood levels higher than 1000 ng/ml
Opzet
Deelname
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In overige registers
Register | ID |
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NTR-new | NL1246 |
NTR-old | NTR1292 |
Ander register | : METC/2003-139/ME 03-08 |
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