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

N/ATerminatedNCT01948999

University of Aarhus3 enrolled

Overview

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.

The purpose of the study is not achieved.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Treatment-refractory Schizophrenia

Interventions

ECTPROCEDURE

Electroconvulsive Therapy inclusive anesthesia and concomitant muscular paralysis

SHAM ECTPROCEDURE

Anesthesia and concomitant muscular paralysis

AnesthesiaDRUG

Temporary induced state of analgesia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.

Data from ClinicalTrials.gov

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