Ignite Creation Date:
2024-05-06 @ 8:05 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02667353
Status:
COMPLETED
Last Update Posted:
2016-01-28
First Post:
2016-01-18
Brief Title:
Neurorestorative Effects of Electroconvulsive Therapy ECT in Patients With Severe Late Life Depression
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Structural Brain Plasticity in Elderly Depressed Patients Following Electroconvulsive Therapy
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
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:
None
Brief Summary:
To study the potential neurorestorative effects of electroconvulsive therapy ECT in depressed patients by measuring brain derived neurotrophic factor BDNF serum levels and hippocampal volumes in severely depressed patients receiving ECT
Detailed Description:
The investigators want to study the potential neurorestorative effects of electroconvulsive therapy ECT in depressed patients by measuring brain derived neurotrophic factor BDNF serum levels and hippocampal volumes in severely depressed patients receiving ECT
Clinical studies in severely depressed patients have shown that antidepressants and ECT can increase Brain Derived Neurotrophic Factor BDNF serum levels BDNF serum levels will be measured before during and after ECT In animal studies this increase in serum BDNF was shown to induce hippocampal mossy fiber sprouting and the investigators want to study this phenomenon in humans Recently a volumetric magnetic resonance imaging study showed increased hippocampal volume in patients with depression Hippocampal volumes will be determined with magnetic resonance imaging scannings including voxel based morphometry Severe depression is accompanied by a dysfunction of the hypothalamus pituitary adrenal HPA axis Cortisol and several other hormones have psychotropic effects and their excesses or deficiencies induce states of mania or depression High levels of cortisol suppress hippocampal neurogenesis Animal models have shown that this suppressive effect of cortisol on hippocampal neurogenesis could be reversed to normal levels by electroconvulsive stimulation the animal model for ECT This animal study is in good accordance with clinical findings
The investigators hypothesize the following Increase of brain-derived neurotrophic factor serum levels induced by electroconvulsive therapy are associated with remission and is correlated with a neurorestorative effect which is an increase of hippocampal volume Non- response to ECT is explained by either low BDNF serum levels regardless of hippocampus size or by more advanced medial temporal lobe atrophy beyond a point of no return despite increased BDNF serum levels
Additionally four relevant functional candidate genes will be examined based on their putative role in neurotrophic processes andor in treatment response in depression the brain derived neurotrophic factor gene the serotonin transporter gene the vascular endothelial growth factor gene and the apolipoprotein gene
The investigators will also evaluate cognitive and psychomotor changes following electroconvulsive therapy given their clinical relevance in late life depression
Clinical studies in severely depressed patients have shown that antidepressants and ECT can increase Brain Derived Neurotrophic Factor BDNF serum levels BDNF serum levels will be measured before during and after ECT In animal studies this increase in serum BDNF was shown to induce hippocampal mossy fiber sprouting and the investigators want to study this phenomenon in humans Recently a volumetric magnetic resonance imaging study showed increased hippocampal volume in patients with depression Hippocampal volumes will be determined with magnetic resonance imaging scannings including voxel based morphometry Severe depression is accompanied by a dysfunction of the hypothalamus pituitary adrenal HPA axis Cortisol and several other hormones have psychotropic effects and their excesses or deficiencies induce states of mania or depression High levels of cortisol suppress hippocampal neurogenesis Animal models have shown that this suppressive effect of cortisol on hippocampal neurogenesis could be reversed to normal levels by electroconvulsive stimulation the animal model for ECT This animal study is in good accordance with clinical findings
The investigators hypothesize the following Increase of brain-derived neurotrophic factor serum levels induced by electroconvulsive therapy are associated with remission and is correlated with a neurorestorative effect which is an increase of hippocampal volume Non- response to ECT is explained by either low BDNF serum levels regardless of hippocampus size or by more advanced medial temporal lobe atrophy beyond a point of no return despite increased BDNF serum levels
Additionally four relevant functional candidate genes will be examined based on their putative role in neurotrophic processes andor in treatment response in depression the brain derived neurotrophic factor gene the serotonin transporter gene the vascular endothelial growth factor gene and the apolipoprotein gene
The investigators will also evaluate cognitive and psychomotor changes following electroconvulsive therapy given their clinical relevance in late life depression
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