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ECT for patients suffering from clozapine resistant schizophrenia


- candidate number3225
- NTR NumberNTR1292
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-apr-2008
- Secondary IDsMETC/2003-139/ME 03-08 
- Public TitleECT for patients suffering from clozapine resistant schizophrenia
- Scientific TitleA single-blind, prospective, randomised, controlled study into the efficacy of electroconvulsive therapy (ECT) as treatment of clozapine-resistant schizophrenic patients
- ACRONYMN/A
- hypothesisECT is effective as treatment of psychosis in patients suffering from clozapine resistant schizophrenia.
- Healt Condition(s) or Problem(s) studiedSchizophrenia, Psychosis, Clozapine, Electroconvulsive therapy
- Inclusion criteria1. 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 criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 11-feb-2003
- planned closingdate1-dec-2008
- Target number of participants40
- InterventionsClozapine vs. clozapine + ECT
- Primary outcomePositive symptoms score on the Positive and Negative syndrome scale (PANSS)
- Secondary outcomeBPRS score
- TimepointsBaseline, two weeks, four weeks, six weeks (end point)
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. O. Nielsen
- CONTACT for SCIENTIFIC QUERIESDr. K.H. Kho
- Sponsor/Initiator GGZ Delfland
- Funding
(Source(s) of Monetary or Material Support)
GGZ Delfland
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD22-apr-2008 - 2-mei-2008


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