Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121888
Status:
COMPLETED
Last Update Posted:
2014-06-06
First Post:
2005-07-14
Brief Title:
Trial of Paroxetine-CR for the Treatment of Patients With Post Traumatic Stress Disorder Remaining Symptomatic After Initial Exposure Therapy
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Randomized Trial of Paroxetine-CR for the Treatment of Patients With Post Traumatic Stress Disorder Remaining Symptomatic After Initial Exposure Therapy
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:
None
Brief Summary:
The purpose of the study is to evaluate the effectiveness and tolerability of controlled-release paroxetine Paxil-CR compared to placebo an inactive substance for individuals who continue to have symptoms of post traumatic stress disorder PTSD despite receiving prolonged exposure therapy
Detailed Description:
Post Traumatic Stress Disorder PTSD is common in the general population with the National Comorbidity Survey reporting a lifetime prevalence of about 8 in the United States Kessler et al 1995 PTSD is associated with marked symptomatic distress as well as significant impairment dysfunction and reduction in overall quality of life Kessler 2000 Both pharmacotherapeutic interventions including serotonin selective reuptake inhibitors SSRIs and psychosocial interventions such as cognitive-behavior therapy CBT have demonstrated efficacy for PTSD Davidson 2001 Foa 2000 However although these interventions can be helpful many patients remain symptomatic despite initial treatment There is little data available to guide practice regarding the efficacy of next step strategies for patients remaining symptomatic despite treatment
In this study the researchers will examine the relative efficacy of the addition of the SSRI paroxetine-CR compared to placebo for patients remaining symptomatic despite a brief and intensive course of CBT
This is a two phase 14-16 week research study in which participants who remain symptomatic at the end of one phase 4-6 weeks enter into the next phase In phase I all participants receive prolonged exposure PE therapy Participants who continue to have significant distress because of posttraumatic stress disorder after 8 sessions of therapy will enter Phase II In Phase II subjects will receive 5 more sessions of PE therapy and be randomly assigned by chance like a flip of a coin to receive paroxetine-cr Paxil-CR or placebo contains no active medication Participants receive this combined treatment over the next 10 weeks
In this study the researchers will examine the relative efficacy of the addition of the SSRI paroxetine-CR compared to placebo for patients remaining symptomatic despite a brief and intensive course of CBT
This is a two phase 14-16 week research study in which participants who remain symptomatic at the end of one phase 4-6 weeks enter into the next phase In phase I all participants receive prolonged exposure PE therapy Participants who continue to have significant distress because of posttraumatic stress disorder after 8 sessions of therapy will enter Phase II In Phase II subjects will receive 5 more sessions of PE therapy and be randomly assigned by chance like a flip of a coin to receive paroxetine-cr Paxil-CR or placebo contains no active medication Participants receive this combined treatment over the next 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