SchizophreniaESBECTNCT02511509
Bifrontal and Bitemporal Electroconvulsive Therapy (ECT) in Treatment of Patients With Schizophrenia
A study testing Bifrontal electroconvulsive therapy and Bitemporal electroconvulsive therapy in people with Schizophrenia, run by Medical University of Lodz at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Bifrontal electroconvulsive therapy and Bitemporal electroconvulsive therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2015to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz
Lodz, 92-213
Jakub Kaźmierski, PhD, 0048426757232, jakub.kazmierski@umed.lodz.pl
About this study
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
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
- Being tested
- Bifrontal electroconvulsive therapy, Bitemporal electroconvulsive therapy
- Keywords
- Schizophrenia, Electroconvulsive Therapy, Bifrontal ECT, Bitemporal ECT, Cognitive functions, Postictal delirium
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifrontal electroconvulsive therapyDevice
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 therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Bitemporal electroconvulsive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale
Assessment conducted on baseline, after 6th, 12th and the last ECT.
Measured: up to 5 weeks
Clinical Global Impression
Assessment conducted on baseline, after 6th, 12th and the last ECT.
Measured: up to 5 weeks
Memorial Delirium Assessment Scale
Assessment conducted after the each ECT course.
Measured: up to 5 weeks
Confusion Assessment Method
Assessment conducted after the each ECT course.
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: up to 5 weeks
Secondary outcomes (4)
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.
Measured: up to 5 weeks
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
Measured: up to 5 weeks
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
Measured: up to 5 weeks
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
Measured: up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2018 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakub Kazmierski, Medical University of Lodz
- Investigators
- Iwona Kloszewska, Prof., Principal investigator, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511509
- Sponsor's protocol ID
- RNN/535/10/KB
- Acronym
- ESBECT
- Status last verified
- Sep 2016
- First submitted
- 9 Jul 2015
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02511509
- Acronym / sponsor ID
- ESBECT / RNN/535/10/KB
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Electroconvulsive Therapy, Bifrontal ECT, Bitemporal ECT, Cognitive functions, Postictal delirium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bifrontal electroconvulsive therapy | Experimental | Device: Bifrontal electroconvulsive therapyThe 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. |
| Bitemporal electroconvulsive therapy | Active comparator | Device: Bitemporal electroconvulsive therapyThe 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifrontal electroconvulsive therapyThe 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. | Device | Bifrontal electroconvulsive therapy |
| Bitemporal electroconvulsive therapyThe 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. | Device | Bitemporal electroconvulsive therapy |
Primary outcome
Positive and Negative Syndrome Scale
Time frame: up to 5 weeks
Assessment conducted on baseline, after 6th, 12th and the last ECT.
Clinical Global Impression
Time frame: up to 5 weeks
Assessment conducted on baseline, after 6th, 12th and the last ECT.
Memorial Delirium Assessment Scale
Time frame: up to 5 weeks
Assessment conducted after the each ECT course.
Confusion Assessment Method
Time frame: up to 5 weeks
Assessment conducted after the each ECT course.
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).
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).
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)
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)
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)
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)
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).
4 secondary outcomes
Positron Emission Tomography to assess the impact of ECT on the dopaminergic system activity
Time frame: up to 5 weeks
The concentration of brain-derived neurotrophic factor.
Time frame: up to 5 weeks
The concentration of neuron specific enolase.
Time frame: up to 5 weeks
The concentration of protein S100B
Time frame: up to 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iwona Kloszewska, Prof. principal investigator
Medical University of Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifrontal electroconvulsive therapy and Bitemporal electroconvulsive therapy in people with Schizophrenia, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jakub Kazmierski, PhD (0048426757232, jakub.kazmierski@umed.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (time frame: up to 5 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2016.