- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02511509
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
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- 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
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Lodz, Poland, 92-213
- Recruiting
- Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz
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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 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 |
Intervention / Treatment |
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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.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive and Negative Syndrome Scale
Time Frame: up to 5 weeks
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Assessment conducted on baseline, after 6th, 12th and the last ECT.
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up to 5 weeks
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Clinical Global Impression
Time Frame: up to 5 weeks
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Assessment conducted on baseline, after 6th, 12th and the last ECT.
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up to 5 weeks
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Memorial Delirium Assessment Scale
Time Frame: up to 5 weeks
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Assessment conducted after the each ECT course.
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up to 5 weeks
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Confusion Assessment Method
Time Frame: up to 5 weeks
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Assessment conducted after the each ECT course.
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up to 5 weeks
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Verbal Memory Test
Time Frame: up to 5 weeks
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Assessment conducted on baseline, after the 6th ECT and one week after the last ECT (24 hours after each ECT course).
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up to 5 weeks
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Visual Memory Test
Time Frame: up to 5 weeks
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Assessment conducted on baseline, after the 6th ECT and one week after the last ECT (24 hours after each ECT course).
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up to 5 weeks
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Finger Tapping Test
Time Frame: up to 5 weeks
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Assessment conducted on baseline, after the 6th ECT and one week after the last ECT (24 hours after each ECT course)
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up to 5 weeks
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Symbol Digit Coding Test
Time Frame: up to 5 weeks
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Assessment conducted on baseline, after the 6th ECT and one week after the last ECT (24 hours after each ECT course)
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up to 5 weeks
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Stroop Test
Time Frame: up to 5 weeks
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Assessment conducted on baseline, after the 6th ECT and one week after the last ECT (24 hours after each ECT course)
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up to 5 weeks
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Shifting Attention Test
Time Frame: up to 5 weeks
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Assessment conducted on baseline, after the 6th ECT and one week after the last ECT (24 hours after each ECT course)
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up to 5 weeks
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Continuous Performance Test
Time Frame: up to 5 weeks
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Assessment conducted on baseline, after the 6th ECT and one week after the last ECT (24 hours after each ECT course).
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up to 5 weeks
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Secondary Outcome Measures
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
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Assessment conducted before the first and after the last ECT course.
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up to 5 weeks
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The concentration of brain-derived neurotrophic factor.
Time Frame: up to 5 weeks
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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
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up to 5 weeks
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The concentration of neuron specific enolase.
Time Frame: up to 5 weeks
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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
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up to 5 weeks
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The concentration of protein S100B
Time Frame: up to 5 weeks
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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
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up to 5 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
September 1, 2015
Primary Completion (Anticipated)
July 1, 2018
Study Completion (Anticipated)
July 1, 2019
Study Registration Dates
First Submitted
July 9, 2015
First Submitted That Met QC Criteria
July 27, 2015
First Posted (Estimate)
July 30, 2015
Study Record Updates
Last Update Posted (Estimate)
October 3, 2016
Last Update Submitted That Met QC Criteria
September 29, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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