Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-31 @ 12:24 PM
Study NCT ID:
NCT00337012
Status:
UNKNOWN
Last Update Posted:
2008-12-01
First Post:
2006-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Duloxetine on Interoceptive Awareness
Sponsor:
University Hospital, Bonn
Organization:
Study Overview
Official Title:
The Effect of Duloxetine on Interoceptive Awareness, Thermal Heat Pain Perception, and Bodily Symptoms in Major Depressive: a Pilot Study With fMRI.
Status:
UNKNOWN
Status Verified Date:
2008-11
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:
This study focuses on possible mechanism mediating duloxetine effects on painful physical symptoms in patients suffering from MDD. Our hypothesis is based on the assump¬tion of dual impairment of the somatosensory system in these patients. Hypalgesia to phasic experimental pain may be due to diminished spinal and brainstem transmission. Hyperalgesia may be at¬tributed to increased interoceptive perception (somatic complaints, especially those consist¬ing in pain) due to sensitisation or lack of inhibition of the interceptive perception. These ef¬fects seem to be mediated by specific brain regions (e.g. the right insula). The investigators intent to test if duloxetine effects on these somatic complaints, especially pain complaints are due to a nor¬malization of these interceptive alterations which have been reported to be associated with depressive symptoms. The investigators hypothesize that treatment with duloxetine will normalize "patho¬logical" activation patterns (as assessed by fMRI) associated with increased interoceptive perception.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: