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).
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 (12.5 mg/d - 62.5 mg/d) or placebo in conjunction with additional 5 sessions of prolonged exposure over 10 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
17
University of California at San Diego
San Diego, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Short PTSD Rating Interview (SPRINT)
Davidson Trauma Scale (DTS)
Clinical Global Impressions Severity Scale (CGI-S)
Clinical Global Impressions Improvement Scale (CGI-I)
Posttraumatic Diagnostic Scale (PDS)
Beck Depression Inventory (BDI)
Quality of Life Enjoyment and Satisfaction Questionnaire/General Activities Subscale (Q-LES-Q/GA)
Sheehan Disability Scale (SDS)
Connor-Davidson Resilience Scale (CD-RISC)
Post-Traumatic Cognitions Inventory (PTCI)
Severity of Symptoms Scale (SOSS)
Pittsburgh Sleep Quality Index (PSQI)
World Assumptions Scale (WAS)
Mood-SR Lifetime
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