No registrations found.
ID
Source
Brief title
Health condition
psychosis, schizophrenia, clozapine, electroconvulsive therapy
Sponsors and support
Intervention
Outcome measures
Primary outcome
Positive symptoms score on the Positive and Negative syndrome scale (PANSS)
Secondary outcome
BPRS score
Background summary
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.
Study objective
ECT is effective as treatment of psychosis in patients suffering from clozapine resistant schizophrenia.
Study design
Baseline, two weeks, four weeks, six weeks (end point)
Intervention
Clozapine vs. clozapine + ECT
St Jorisweg 2
O. Nielsen
Delft 2612 GA
The Netherlands
+31 (0)15 2607651
St Jorisweg 2
O. Nielsen
Delft 2612 GA
The Netherlands
+31 (0)15 2607651
Inclusion criteria
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)
Exclusion criteria
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1246 |
| NTR-old | NTR1292 |
| Other | : METC/2003-139/ME 03-08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |