Ignite Creation Date:
2024-05-06 @ 8:45 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02810717
Status:
UNKNOWN
Last Update Posted:
2018-08-16
First Post:
2016-06-01
Brief Title:
Effects of TBS on 5-HT1A Receptor Binding
Sponsor:
Rupert Lanzenberger
Organization:
Medical University of Vienna
Study Overview
Official Title:
Effects of Theta-burst Transcranial Magnetic Stimulation on Serotonin-1A Receptor Binding in Treatment Resistant Depression
Status:
UNKNOWN
Status Verified Date:
2018-08
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:
None
Brief Summary:
Background
Theta-burst stimulation TBS a form of repetitive transcranial magnetic stimulation rTMS holds promise as an effective treatment for treatment resistant depression TRD rTMS has been linked to neuroplastic changes as shown using magnetic resonance imaging MRI and positron emission tomography PET Alterations in serotonin-1A receptor expression 5-HT1A have been linked to major depression Moreover changes in 5-HT1A receptor binding - observed after pharmacological treatment as well as after electroconvulsive therapy - has been linked to neuronal adaptations in response to these antidepressant treatments
Objectives of the study
Here the aim is to investigate the effects of TBS over left and right dorsolateral prefrontal cortex on the 5-HT1A receptor binding in patients with TRD using PET In addition effects of iTBS on brain structure and function will be determined using functional structural and perfusion MRI
Study population
80 patients with TRD who maintain their original medication regimen will be recruited
Study design
Longitudinal randomized and double-blind clinical trial 40 patients will receive active TBS 40 patients will receive sham TBS for treatment duration of three weeks Before and after three weeks of treatment patients will be scanned using MRI and PET with the highly specific and selective radiotracer carbonyl-11CWAY100635 A follow-up visit and final examination will be performed 2 and 4 weeks after treatment for the active TBS group respectively Patients in the sham TBS arm will receive active TBS treatment immediately after the second MRI and PET scan
Relevance and implications of the study
This will be the worldwide first multimodal imaging study to investigate the effects of TBS on serotonin-1A receptor binding in TRD using PET Thus the study will add crucial knowledge to the existing literature on the effects of TMS on brain structure and function related to antidepressant efficacy Moreover by combining molecular imaging of serotonergic neurotransmission with structural and functional MRI the proposed study will increase the investigators knowledge on the serotonergic role in shaping brain morphology microstructure and structuralfunctional connectivity Taken together the study has the potential to contribute to the development of personalized treatment the reduction of personal suffering and the reduction of costs and occupational disability
Theta-burst stimulation TBS a form of repetitive transcranial magnetic stimulation rTMS holds promise as an effective treatment for treatment resistant depression TRD rTMS has been linked to neuroplastic changes as shown using magnetic resonance imaging MRI and positron emission tomography PET Alterations in serotonin-1A receptor expression 5-HT1A have been linked to major depression Moreover changes in 5-HT1A receptor binding - observed after pharmacological treatment as well as after electroconvulsive therapy - has been linked to neuronal adaptations in response to these antidepressant treatments
Objectives of the study
Here the aim is to investigate the effects of TBS over left and right dorsolateral prefrontal cortex on the 5-HT1A receptor binding in patients with TRD using PET In addition effects of iTBS on brain structure and function will be determined using functional structural and perfusion MRI
Study population
80 patients with TRD who maintain their original medication regimen will be recruited
Study design
Longitudinal randomized and double-blind clinical trial 40 patients will receive active TBS 40 patients will receive sham TBS for treatment duration of three weeks Before and after three weeks of treatment patients will be scanned using MRI and PET with the highly specific and selective radiotracer carbonyl-11CWAY100635 A follow-up visit and final examination will be performed 2 and 4 weeks after treatment for the active TBS group respectively Patients in the sham TBS arm will receive active TBS treatment immediately after the second MRI and PET scan
Relevance and implications of the study
This will be the worldwide first multimodal imaging study to investigate the effects of TBS on serotonin-1A receptor binding in TRD using PET Thus the study will add crucial knowledge to the existing literature on the effects of TMS on brain structure and function related to antidepressant efficacy Moreover by combining molecular imaging of serotonergic neurotransmission with structural and functional MRI the proposed study will increase the investigators knowledge on the serotonergic role in shaping brain morphology microstructure and structuralfunctional connectivity Taken together the study has the potential to contribute to the development of personalized treatment the reduction of personal suffering and the reduction of costs and occupational disability
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