Ignite Creation Date:
2024-05-06 @ 7:21 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02511509
Status:
UNKNOWN
Last Update Posted:
2016-10-03
First Post:
2015-07-09
Brief Title:
Bifrontal and Bitemporal Electroconvulsive Therapy ECT in Treatment of Patients With Schizophrenia
Sponsor:
Medical University of Lodz
Organization:
Medical University of Lodz
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2016-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESBECT
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 werent 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None