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

Not Applicable

Terminated

• Conditions: Treatment-refractory Schizophrenia
• Interventions: Procedure: SHAM ECT; Procedure: ECT; Drug: Anesthesia

• Registration Number: NCT01948999
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-24
• Study Start: 2013-12
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-19
• Last Update Posted: 2016-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHAM ECT	SHAM ECT	Anesthesia and concomitant muscular paralysis
ECT	ECT	Electroconvulsive Therapy Anesthesia and concomitant muscular paralysis
ECT	Anesthesia	Electroconvulsive Therapy Anesthesia and concomitant muscular paralysis
SHAM ECT	Anesthesia	Anesthesia and concomitant muscular paralysis

Primary Outcome Measures

Name	Time	Method
Reduction in total PANSS score and adverse events	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