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

Schizophrenia Clinical Trial

— ESBECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02511509
• Other study ID #: RNN/535/10/KB
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2015
• Last updated: September 29, 2016
• Start date: September 2015
• Est. completion date: July 2019

Study information

• Verified date: September 2016
• Source: Medical Universtity of Lodz
• Contact: Jakub Kazmierski, PhD
• Phone: 0048426757232
• Email: jakub.kazmierski[@]umed.lodz.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale	Assessment conducted on baseline, after 6th, 12th and the last ECT.	up to 5 weeks	No
Primary	Clinical Global Impression	Assessment conducted on baseline, after 6th, 12th and the last ECT.	up to 5 weeks	No
Primary	Memorial Delirium Assessment Scale	Assessment conducted after the each ECT course.	up to 5 weeks	Yes
Primary	Confusion Assessment Method	Assessment conducted after the each ECT course.	up to 5 weeks	Yes
Primary	Verbal Memory Test	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	Yes
Primary	Visual Memory Test	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	Yes
Primary	Finger Tapping Test	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	Yes
Primary	Symbol Digit Coding Test	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	Yes
Primary	Stroop Test	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	Yes
Primary	Shifting Attention Test	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	Yes
Primary	Continuous Performance Test	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	Yes
Secondary	Positron Emission Tomography to assess the impact of ECT on the dopaminergic system activity	Assessment conducted before the first and after the last ECT course.	up to 5 weeks	No
Secondary	The concentration of brain-derived neurotrophic factor.	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	Yes
Secondary	The concentration of neuron specific enolase.	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	Yes
Secondary	The concentration of protein S100B	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	Yes