Ignite Creation Date:
2024-05-05 @ 11:20 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01317147
Status:
COMPLETED
Last Update Posted:
2011-03-17
First Post:
2011-03-15
Brief Title:
The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors
Status:
COMPLETED
Status Verified Date:
2011-03
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:
The morbidly obese frequently present with mood and anxiety disorders which are often treated with serotonin reuptake inhibitors SRI antidepressant drugs The investigators hypothesized that gastric bypass surgery would decrease the absorption of SRI The investigators also wished to determine whether a reduction in SRI levels would increase the likelihood of worsening depressive symptoms
Detailed Description:
Twelve RYGB candidates who were successfully treated with an SRI for primary mood or anxiety disorders were studied prospectively Blood samples for SRI plasma levels were drawn immediately after dose for pharmacokinetic studies PK preoperatively Maximum concentration CMAX time to CMAX TMAX and Area Under ConcentrationTime curve AUC were determined PK studies were repeated at one six and twelve months post-operatively PK data were corrected for dose at each study time point The Structured Interview Guide for the Hamilton Depression Rating Scale- Atypical Depression Symptom Version was used to quantify depressive symptoms
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