Trial of Paroxetine-CR for the Treatment of Patients With Post Traumatic Stress Disorder Remaining Symptomatic After Initial Exposure Therapy
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|ClinicalTrials.gov Identifier: NCT00121888|
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : June 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic||Behavioral: Prolonged Exposure Therapy Drug: Paroxetine-CR||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Trial of Paroxetine-CR for the Treatment of Patients With Post Traumatic Stress Disorder Remaining Symptomatic After Initial Exposure Therapy|
|Study Start Date :||December 2002|
|Actual Study Completion Date :||June 2007|
- Symptoms of post traumatic stress disorder
- Clinical global improvement
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121888
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Naomi M Simon, MD||Massachusetts General Hospital|