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

Primary Purpose

Treatment-refractory Schizophrenia

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ECT
SHAM ECT
Anesthesia
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment-refractory Schizophrenia focused on measuring electroconvulsive therapy, treatment-refractory schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    ECT

    SHAM ECT

    Arm Description

    Electroconvulsive Therapy Anesthesia and concomitant muscular paralysis

    Anesthesia and concomitant muscular paralysis

    Outcomes

    Primary Outcome Measures

    Reduction in total PANSS score and adverse events
    PANSS = Positive and Negative Syndrome Scale and UKU = The UKU (Udvalg for Kliniske Undersøgelser) side effect rating scale

    Secondary Outcome Measures

    Full Information

    First Posted
    June 17, 2013
    Last Updated
    December 19, 2016
    Sponsor
    University of Aarhus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01948999
    Brief Title
    Electroconvulsive Therapy for Treatment Refractory Schizophrenia - A Randomized, Double-blinded, Sham-controlled Study
    Official Title
    Electroconvulsive Therapy for Treatment Refractory Schizophrenia - A Randomized, Double-blinded, Sham-controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Terminated
    Why Stopped
    Missing ressources. The study official has left and will not be replaced
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Treatment-refractory Schizophrenia
    Keywords
    electroconvulsive therapy, treatment-refractory schizophrenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    3 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ECT
    Arm Type
    Active Comparator
    Arm Description
    Electroconvulsive Therapy Anesthesia and concomitant muscular paralysis
    Arm Title
    SHAM ECT
    Arm Type
    Sham Comparator
    Arm Description
    Anesthesia and concomitant muscular paralysis
    Intervention Type
    Procedure
    Intervention Name(s)
    ECT
    Intervention Description
    Electroconvulsive Therapy inclusive anesthesia and concomitant muscular paralysis
    Intervention Type
    Procedure
    Intervention Name(s)
    SHAM ECT
    Intervention Description
    Anesthesia and concomitant muscular paralysis
    Intervention Type
    Drug
    Intervention Name(s)
    Anesthesia
    Intervention Description
    Temporary induced state of analgesia
    Primary Outcome Measure Information:
    Title
    Reduction in total PANSS score and adverse events
    Description
    PANSS = Positive and Negative Syndrome Scale and UKU = The UKU (Udvalg for Kliniske Undersøgelser) side effect rating scale
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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