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

• Status: Terminated
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Treatments: Anesthetics

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

• 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