Bifrontal and Bitemporal Electroconvulsive Therapy (ECT) in Treatment of Patients With Schizophrenia (ESBECT)

September 29, 2016 updated by: Jakub Kazmierski, Medical University of Lodz

Comparison of the Efficacy and Safety of the Bifrontal Electroconvulsive Therapy (ECT) and the Standard Bitemporal ECT in the Treatment of Patients With Schizophrenia

Electroconvulsive therapy has been used in clinical practice since 1938, a number of randomized trials found significant differences favoring ECT in response rates between individuals with depression receiving real and sham ECT. Results of early studies performed on patients with schizophrenia weren't so clear, only few of these trials found appreciable differences between real and sham ECT in clinical outcome. The recent, more reliable studies have found that ECT is efficacious on different symptoms which might be present in the course of schizophrenia, for example, psychotic and affective ones, as well as suicidality. The serious complications of electroconvulsive therapy are rare, however, more frequent side effects may include cognitive impairment and postictal delirium. Thus, the researchers try to develop new, more effective and less harmful procedures of ECT, like bifrontal electrodes. The available studies revealed that bifrontal ECT has equal efficacy to bitemporal ECT with less cognitive impairment, but the literature examining this placement is limited to major depressive disorder and the results are inconsistent. In the worldwide literature there is lack of studies regarding the use of bifrontal ECT among patients with schizophrenia. It is interesting how bifrontal ECT would affect axial symptoms of schizophrenia, since the electrodes in this procedure are placed over the brain areas responsible for negative symptoms. This randomized, double blind study is going to assess whether the bifrontal ECT is more effective in the treatment of positive and negative symptoms of schizophrenia, has less harmful impact on the cognitive functions and decrease the frequency and severity of postictal delirium comparing to the bitemporal ECT. Moreover, as the first worldwide will assess the brain dopaminergic activity with the use of PET in the patients with schizophrenia after ECT and the impact of the ECT on the concentration of such neurotrophins as brain-derived neurotrophic factor-BDNF, neuron specific enolase-NSE and protein S100B.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lodz, Poland, 92-213
        • Recruiting
        • Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patients who met Diagnostic and Statistical Manual-DSM-V criteria for schizophrenia (apart from residual type)
  • The patients qualified for ECT according the standard protocol
  • Antipsychotic treatment with dibenzepins according to the following scheme: the dose of clozapine not higher than 450mg, the dose of olanzapine not higher than 20mg and the dose of quetiapine not higher than 600mg per day
  • If needed concomitant treatment allowed with hydroxyzine (max. 100mg per day) and lorazepam (max. 4mg per day)
  • Anaesthesia conducted with the use of suxamethonium chloride, propofol and atropine

Exclusion Criteria:

  • The lack of patient's consent
  • Mental retardation confirmed with the psychological and psychiatric examination (IQ<70; fulfilled DSM-V criteria for mental retardation)
  • Dementia diagnosed on the basis of DSM-V criteria
  • Substance abuse during the year prior study enrolment or substance addiction
  • The presence of symptoms which met DSM-V criteria for affective episode (an episode of mania, hypomania or depression)
  • The ECT conducted during 6 months prior the study enrolment
  • The history of previous ineffective ECT
  • The need for antipsychotic treatment other than derivatives of dibenzothiazepines or in doses higher than 450mg of clozapine, 20mg of olanzapine and 600mg of quetiapine per day
  • The women in the generative period who do not use effective contraception (sexual abstinence, contraceptives, intrauterine device, mechanical contraceptive devices)
  • The need for use of other than suxamethonium chloride, propofol and atropine anaesthetics and concomitant medications

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bifrontal electroconvulsive therapy
The ECT courses will be held twice or three times a week. There is no stated minimal nor maximal number of ECT courses. If there is no improvement after 12 courses, the ECT will be regarded as ineffective.
Device: Bifrontal electroconvulsive therapy
The centre of each electrode will be placed 4-5 cm above the outer canthus of the eye along a vertical line perpendicular to a line connecting the pupils.
Active Comparator: Bitemporal electroconvulsive therapy
The ECT courses will be held twice or three times a week. There is no stated minimal nor maximal number of ECT courses. If there is no improvement after 12 courses, the ECT will be regarded as ineffective.
Device: Bitemporal electroconvulsive therapy
The centre of the stimulus electrodes will be applied 2-3 cm above the midpoint of the line connecting the outer canthus of the eye and the external auditory meatus on each side of the individual's head.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Positive and Negative Syndrome Scale
Time Frame: up to 5 weeks
Assessment conducted on baseline, after 6th, 12th and the last ECT.
up to 5 weeks
Clinical Global Impression
Time Frame: up to 5 weeks
Assessment conducted on baseline, after 6th, 12th and the last ECT.
up to 5 weeks
Memorial Delirium Assessment Scale
Time Frame: up to 5 weeks
Assessment conducted after the each ECT course.
up to 5 weeks
Confusion Assessment Method
Time Frame: up to 5 weeks
Assessment conducted after the each ECT course.
up to 5 weeks
Verbal Memory Test
Time Frame: up to 5 weeks
Assessment conducted on baseline, after the 6th ECT and one week after the last ECT (24 hours after each ECT course).
up to 5 weeks
Visual Memory Test
Time Frame: up to 5 weeks
Assessment conducted on baseline, after the 6th ECT and one week after the last ECT (24 hours after each ECT course).
up to 5 weeks
Finger Tapping Test
Time Frame: up to 5 weeks
Assessment conducted on baseline, after the 6th ECT and one week after the last ECT (24 hours after each ECT course)
up to 5 weeks
Symbol Digit Coding Test
Time Frame: up to 5 weeks
Assessment conducted on baseline, after the 6th ECT and one week after the last ECT (24 hours after each ECT course)
up to 5 weeks
Stroop Test
Time Frame: up to 5 weeks
Assessment conducted on baseline, after the 6th ECT and one week after the last ECT (24 hours after each ECT course)
up to 5 weeks
Shifting Attention Test
Time Frame: up to 5 weeks
Assessment conducted on baseline, after the 6th ECT and one week after the last ECT (24 hours after each ECT course)
up to 5 weeks
Continuous Performance Test
Time Frame: up to 5 weeks
Assessment conducted on baseline, after the 6th ECT and one week after the last ECT (24 hours after each ECT course).
up to 5 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Positron Emission Tomography to assess the impact of ECT on the dopaminergic system activity
Time Frame: up to 5 weeks
Assessment conducted before the first and after the last ECT course.
up to 5 weeks
The concentration of brain-derived neurotrophic factor.
Time Frame: up to 5 weeks
The blood samples will be collected on baseline, 2 and 6 hours after the first ECT course, 2 hours after the 3rd, 6th, 9th and the last ECT course
up to 5 weeks
The concentration of neuron specific enolase.
Time Frame: up to 5 weeks
The blood samples will be collected on baseline, 2 and 6 hours after the first ECT course, 2 hours after the 3rd, 6th, 9th and the last ECT course
up to 5 weeks
The concentration of protein S100B
Time Frame: up to 5 weeks
The blood samples will be collected on baseline, 2 and 6 hours after the first ECT course, 2 hours after the 3rd, 6th, 9th and the last ECT course
up to 5 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Lodz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Iwona Kloszewska, Prof., Medical University of Lodz, Poland

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RNN/535/10/KB

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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