Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074802
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2003-12-19
Brief Title:
Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
CBT Augmentation of Paroxetine for Social Anxiety
Status:
COMPLETED
Status Verified Date:
2017-05
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:
This study will examine whether the addition of cognitive behavioral therapy can improve the efficacy of the medication paroxetine Paxil in treating individuals with social anxiety disorder Patients with social anxiety disorder will undergo a 12-week open trial with paroxetine Those who complete the open trial having achieved only partial response will be randomized to receive cognitive behavioral therapy CBT in addition to paroxetine or to continue on paroxetine alone for an additional 16 weeks
Detailed Description:
Social anxiety disorder is a prevalent and disabling condition for which effective long-term treatments need to be identified Paroxetine is effective in treating the acute symptoms of social anxiety but many patients achieve less than optimal response CBT has also been effective in treating social anxiety disorder thusit may also be effective in augmenting paroxetine response This study will examine the effects of paroxetine treatment alone and in combination with CBT among patients who achieve less than optimal response after an open trial with paroxetine
Participants in this study will receive paroxetine for 12 weeks Phase 1 After 12 weeks participants who have completed this open trial but have achieved some but less than optimal response will move forward to Phase 2 To be eligible to move forward to Phase 2 patients must have achieved at least a 10 improvement in their open-trial Liebowitz Social Anxiety Scale Scores LSAS but still have an LSAS score of 30 or greater Patients meeting these criteria will be randomly assigned to either add weekly sessions of CBT to their treatment or to continue taking paroxetine alone for another 16 weeks Social anxiety symptoms rates of response and remission fear of negative evaluation disability and quality of life will be assessed
Participants in this study will receive paroxetine for 12 weeks Phase 1 After 12 weeks participants who have completed this open trial but have achieved some but less than optimal response will move forward to Phase 2 To be eligible to move forward to Phase 2 patients must have achieved at least a 10 improvement in their open-trial Liebowitz Social Anxiety Scale Scores LSAS but still have an LSAS score of 30 or greater Patients meeting these criteria will be randomly assigned to either add weekly sessions of CBT to their treatment or to continue taking paroxetine alone for another 16 weeks Social anxiety symptoms rates of response and remission fear of negative evaluation disability and quality of life will be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| GSK ID 101618 | OTHER | GlaxoSmithKline | httpsreporternihgovquickSearchR01MH064726 |
| R01MH064481 | NIH | None | None |
| DSIR 83-ATAS | None | None | None |
| R01MH064726 | NIH | None | None |