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

University of Aarhus

Status: Terminated

Conditions: Treatment-refractory Schizophrenia

Treatments: Drug: Anesthesia; Procedure: ECT; Procedure: SHAM ECT

Study type: Interventional

Funder types: Other

Identifiers

NCT01948999

N-20100085

Details and patient eligibility

About

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.

Full description

The purpose of the study is not achieved.

Enrollment: 3 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3 participants in 2 patient groups

ECT

Active Comparator group

Description:

Electroconvulsive Therapy Anesthesia and concomitant muscular paralysis

Treatment:

Drug: Anesthesia

Procedure: ECT

SHAM ECT

Sham Comparator group

Description:

Anesthesia and concomitant muscular paralysis

Treatment:

Drug: Anesthesia

Procedure: SHAM ECT