Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248651
Status:
COMPLETED
Last Update Posted:
2014-07-25
First Post:
2005-11-03
Brief Title:
Functional Dyspepsia Treatment Trial
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Antidepressant Therapy for Functional Dyspepsia
Status:
COMPLETED
Status Verified Date:
2014-06
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:
FDTT
Brief Summary:
Functional dyspepsia is a common gastrointestinal disorder Symptoms can include stomach pain or discomfort bloating fullness after eating meals and nausea These symptoms often interfere with school and work and weight loss may occur due to dietary restrictions
The hypothesis of this study was that antidepressant therapy is more effective than placebo in relief of the symptoms of functional dyspepsia adjusting for psychological and psychiatric co-morbidity The study also examined if antidepressant therapy reduces disability and improves quality of life in functional dyspepsia
The hypothesis of this study was that antidepressant therapy is more effective than placebo in relief of the symptoms of functional dyspepsia adjusting for psychological and psychiatric co-morbidity The study also examined if antidepressant therapy reduces disability and improves quality of life in functional dyspepsia
Detailed Description:
The aims of this study were to
1 Determine whether antidepressant therapy is more efficacious than placebo in relief of the symptoms of functional dyspepsia adjusting for psychological and psychiatric co-morbidity The investigators also planned to determine if antidepressant therapy reduces disability improves quality of life and influences clinical response over 6 months after ceasing medication
2 Determine if gastric emptying motor dysfunction and the nutrient drink test a test that assesses gastric hypersensitivity andor gastric accommodation is altered by antidepressant therapy with a tricyclic or selective serotonin re-uptake inhibitors SSRI and whether subgroups with altered physiology are associated with treatment outcome
1 Determine whether antidepressant therapy is more efficacious than placebo in relief of the symptoms of functional dyspepsia adjusting for psychological and psychiatric co-morbidity The investigators also planned to determine if antidepressant therapy reduces disability improves quality of life and influences clinical response over 6 months after ceasing medication
2 Determine if gastric emptying motor dysfunction and the nutrient drink test a test that assesses gastric hypersensitivity andor gastric accommodation is altered by antidepressant therapy with a tricyclic or selective serotonin re-uptake inhibitors SSRI and whether subgroups with altered physiology are associated with treatment outcome
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DK065713 | NIH | None | httpsreporternihgovquickSearchU01DK065713 |