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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The concentration of brain-derived neurotrophic factor. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jakub Kazmierski, PhD | Contact | 0048426757232 | jakub.kazmierski@umed.lodz.pl |
| Name | Affiliation | Role |
|---|---|---|
| Iwona Kloszewska, Prof. | Medical University of Lodz, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz | Recruiting | Lodz | 92-213 | Poland |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| 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. |
|
| 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 |
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. | 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 | 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 |