Electroconvulsive Therapy for Treatment Refractory Schizophrenia - A Randomized, Double-blinded, Sham-controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- ECT
- Conditions
- Treatment-refractory Schizophrenia
- Sponsor
- University of Aarhus
- Enrollment
- 3
- Primary Endpoint
- Reduction in total PANSS score and adverse events
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
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
The purpose of the study is not achieved.
Investigators
Eligibility Criteria
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
- •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
Arms & Interventions
ECT
Electroconvulsive Therapy Anesthesia and concomitant muscular paralysis
Intervention: ECT
ECT
Electroconvulsive Therapy Anesthesia and concomitant muscular paralysis
Intervention: Anesthesia
SHAM ECT
Anesthesia and concomitant muscular paralysis
Intervention: SHAM ECT
SHAM ECT
Anesthesia and concomitant muscular paralysis
Intervention: Anesthesia
Outcomes
Primary Outcomes
Reduction in total PANSS score and adverse events
Time Frame: 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.
PANSS = Positive and Negative Syndrome Scale and UKU = The UKU (Udvalg for Kliniske Undersøgelser) side effect rating scale