Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215163
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2005-09-20
Brief Title:
Paroxetine-CR to Treat Post-Traumatic Stress Disorder PTSD Symptomatic After Initial Exposure Therapy
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Randomized Trial of Paroxetine-CR for the Treatment of Patients With Post-Traumatic Stress Disorder PTSD Remaining Symptomatic After Initial Exposure Therapy
Status:
COMPLETED
Status Verified Date:
2005-09
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:
Both pharmacotherapeutic and psychosocial interventions have domenstrated efficacy for PTSD However although these interventions can be helpful many patients remain symptomatic despite initial treatment In this study we will examine the relative efficacy of the addition of paroxetine-CR compared to placebo for patients remaining symptomatic despite a brief and intensive course of cognitive-behavioral therapy CBT
Detailed Description:
This is a systematic controlled study examining the use of augmentation with pharmaotherapy for PTSD patients remaining symptomatic despite CBT exposure therapy The aims of the study include examination of 1 the efficacy of paroxetine-CR compared to placebo as additions to ongoing exposure therapy in patients who failed to respond to brief intensive CBT 2 the tolerability of paroxetine-CR compared to placebo as additions to ongoing exposure therapy in patients who failed to respond to brief intensive CBT 3 the outcome of patients at 6 months follow-up to randomized treatment Patients will initially have intensive 8 sessions over 4 weeks prolonged exposure therapy Patients who remain symptomatic will be randomzied to receive either flexibly-dosed paroxetine-CR 125 mgd - 625 mgd or placebo in conjunction with additional 5 sessions of prolonged exposure over 10 weeks
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 |
|---|---|---|---|
| 4304-02-12 | OTHER | Duke IRB | None |