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

December 19, 2016 updated by: University of Aarhus
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study is not achieved.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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
Drug: Anesthesia
Temporary induced state of analgesia
Procedure: SHAM ECT
Anesthesia and concomitant muscular paralysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

September 23, 2013

First Posted (ESTIMATE)

September 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 20, 2016

Last Update Submitted That Met QC Criteria

December 19, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20100085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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