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

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ClinicalTrials.gov Identifier: NCT01948999
Recruitment Status : Terminated (Missing ressources. The study official has left and will not be replaced)
First Posted : September 24, 2013
Last Update Posted : December 20, 2016
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief 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.

Condition or disease Intervention/treatment Phase
Treatment-refractory Schizophrenia Procedure: ECT Procedure: SHAM ECT Drug: Anesthesia Not Applicable

Detailed Description:
The purpose of the study is not achieved.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Electroconvulsive Therapy for Treatment Refractory Schizophrenia - A Randomized, Double-blinded, Sham-controlled Study
Study Start Date : December 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: ECT
Electroconvulsive Therapy Anesthesia and concomitant muscular paralysis
Procedure: ECT
Electroconvulsive Therapy inclusive anesthesia and concomitant muscular paralysis

Drug: Anesthesia
Temporary induced state of analgesia

Sham Comparator: SHAM ECT
Anesthesia and concomitant muscular paralysis
Procedure: SHAM ECT
Anesthesia and concomitant muscular paralysis

Drug: Anesthesia
Temporary induced state of analgesia




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01948999     History of Changes
Other Study ID Numbers: N-20100085
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Aarhus:
electroconvulsive therapy
treatment-refractory schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs