Electroconvulsive Therapy for Treatment Refractory Schizophrenia - A Randomized, Double-blinded, Sham-controlled Study

Study Overview
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Brief Summary
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The purpose of the study is to determine whether addition of electroconvulsive therapy to antipsychotic treatment improves the mental health of patients with treatment-resistant schizophrenia.

Detailed Description
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The purpose of the study is not achieved.

Official Title
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Electroconvulsive Therapy for Treatment Refractory Schizophrenia - A Randomized, Double-blinded, Sham-controlled Study

Conditions
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Treatment-refractory Schizophrenia

Intervention / Treatment
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* Procedure: ECT
* Procedure: SHAM ECT
* Drug: Anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An ICD-10 schizophrenia diagnosis F20.0-20.3 or F20.9 PANSS total score >= 70 CGI-S >= 4 (Clinical Global Impression) PANSS score >= 4 on minimum 2 og the following items: Delusions, Conceptual disorganization,Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness, Hostility, Disorientation. Previous/current treated with clozapine or refused clozapine treatment Lack of response to at least three different antipsychotics New antipsychotic medication prescribed more than 8 weeks before inclusion Fixed dosage of antipsychotics 1 month before inclusion No chance of additional neurotropic 4 weeks before inclusion Signed informed consent and power of attorney Exclusion Criteria: Significant substance abuse Somatic disease that increases the risk of complications of ECT/anesthesia Epilepsy For women: Pregnancy or breast-feeding Homelessness Use of benzodiazepines (apart from tbl. oxazepam 10 mg., max 30 mg. daily) Use of antiepileptic Previous no effect on psychotic symptoms after ECT treatment (minimum 15 ECT- treatments) Concrete suicidal plans

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ECT<br>Electroconvulsive Therapy Anesthesia and concomitant muscular paralysis | Procedure: ECT<br>* Electroconvulsive Therapy inclusive anesthesia and concomitant muscular paralysis<br>Drug: Anesthesia<br>* Temporary induced state of analgesia<br>|
| Sham Comparator: SHAM ECT<br>Anesthesia and concomitant muscular paralysis | Procedure: SHAM ECT<br>* Anesthesia and concomitant muscular paralysis<br>Drug: Anesthesia<br>* Temporary induced state of analgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in total PANSS score and adverse events | PANSS = Positive and Negative Syndrome Scale and UKU = The UKU (Udvalg for Kliniske Undersøgelser) side effect rating scale | The primary outcome will be assessed at screening, baseline and after every second week up to 72 weeks depending on the process for the individaul participant. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electroconvulsive therapy, treatment-refractory schizophrenia