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

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.

Full Title of Study: “Electroconvulsive Therapy for Treatment Refractory Schizophrenia – A Randomized, Double-blinded, Sham-controlled Study”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: December 2016

Detailed Description

The purpose of the study is not achieved.

Interventions

• Procedure: ECT
  • Electroconvulsive Therapy inclusive anesthesia and concomitant muscular paralysis
• Procedure: SHAM ECT
  • Anesthesia and concomitant muscular paralysis
• Drug: Anesthesia
  • Temporary induced state of analgesia

Arms, Groups and Cohorts

• Active Comparator: ECT
  • Electroconvulsive Therapy Anesthesia and concomitant muscular paralysis
• Sham Comparator: SHAM ECT
  • Anesthesia and concomitant muscular paralysis

Clinical Trial Outcome Measures

Primary Measures

• 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University of Aarhus
• Provider of Information About this Clinical Study
  • Sponsor