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

NCT02511509 | Unknown

• 1 other identifier: RNN/535/10/KB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Electroconvulsive Therapy; Bifrontal ECT; Bitemporal ECT; Cognitive functions; Postictal delirium

Outcome Measures

Primary Outcomes (11)

• Positive and Negative Syndrome Scale

  Assessment conducted on baseline, after 6th, 12th and the last ECT.

  up to 5 weeks

• Clinical Global Impression

  Assessment conducted on baseline, after 6th, 12th and the last ECT.

  up to 5 weeks

• Memorial Delirium Assessment Scale

  Assessment conducted after the each ECT course.

  up to 5 weeks

• Confusion Assessment Method

  Assessment conducted after the each ECT course.

  up to 5 weeks

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (4)

• Positron Emission Tomography to assess the impact of ECT on the dopaminergic system activity

  up to 5 weeks

• The concentration of brain-derived neurotrophic factor.

  up to 5 weeks

• The concentration of neuron specific enolase.

  up to 5 weeks

• The concentration of protein S100B

  up to 5 weeks

Study Arms (2)

Bifrontal electroconvulsive therapy

EXPERIMENTAL

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

Bitemporal electroconvulsive therapy

ACTIVE COMPARATOR

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

Interventions

Bifrontal electroconvulsive therapy DEVICE

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.

Bifrontal electroconvulsive therapy

Bitemporal electroconvulsive therapy DEVICE

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.

Bitemporal electroconvulsive therapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz

Lodz, 92-213, Poland

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Iwona Kloszewska, Prof.

  Medical University of Lodz, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakub Kazmierski, PhD

CONTACT

0048426757232; jakub.kazmierski@umed.lodz.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 30, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2019
• Last Updated: October 3, 2016

Record last verified: 2016-09

Locations

PL (1)