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


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.


  • 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 Unders√łgelser) 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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.