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CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
Sertraline treatment of posttraumatic stress disorder: results of 24 weeks of open-label continuation treatment.
Journal of Clinical Psychiatry 2001 May
BACKGROUND: Posttraumatic stress disorder (PTSD) is typically associated with a high degree of chronicity, comorbidity, and psychosocial disability. The efficacy of sertraline in the acute treatment of PTSD has been confirmed based on the results of 2 large, placebo-controlled studies, but almost no prospective long-term treatment studies have been reported.
METHOD: One hundred twenty-eight patients who completed 12 weeks of double-blind, placebo-controlled, acute-phase treatment for DSM-III-R-defined PTSD with sertraline were continued into a 24-week open-label continuation phase. Efficacy was evaluated using the endpoint change in the 17-item Clinician Administered PTSD Scale Part 2 (CAPS-2) severity score, the 15-item patient-rated Impact of Event Scale, and the Clinical Global Impressions-Improvement and -Severity of Illness scales as primary outcome measures. Treatment response was defined as > or =30% decrease in the CAPS-2 total severity score (compared with acute-phase baseline score) and a Clinical Global Impressions-Improvement score of 1 or 2.
RESULTS: Ninety-two percent of acute-phase responders maintained their response during the full 6 months of continuation treatment. In addition, 54% of acute-phase nonresponders converted to responder status during continuation therapy. Over the 36-week course of acute and continuation therapy, 20% to 25% of the improvement in the CAPS-2 severity score occurred during the continuation phase. Sertraline was well tolerated, with 8.6% of patients discontinuing due to adverse events. A high pretreatment CAPS-2 score (> 75) predicted a longer time to response and a greater likelihood that response occurred after 12 weeks of acute treatment.
CONCLUSION: The acute efficacy of sertraline is sustained in the vast majority of patients, and at least half of nonresponders to acute treatment will eventually respond to continued treatment.
METHOD: One hundred twenty-eight patients who completed 12 weeks of double-blind, placebo-controlled, acute-phase treatment for DSM-III-R-defined PTSD with sertraline were continued into a 24-week open-label continuation phase. Efficacy was evaluated using the endpoint change in the 17-item Clinician Administered PTSD Scale Part 2 (CAPS-2) severity score, the 15-item patient-rated Impact of Event Scale, and the Clinical Global Impressions-Improvement and -Severity of Illness scales as primary outcome measures. Treatment response was defined as > or =30% decrease in the CAPS-2 total severity score (compared with acute-phase baseline score) and a Clinical Global Impressions-Improvement score of 1 or 2.
RESULTS: Ninety-two percent of acute-phase responders maintained their response during the full 6 months of continuation treatment. In addition, 54% of acute-phase nonresponders converted to responder status during continuation therapy. Over the 36-week course of acute and continuation therapy, 20% to 25% of the improvement in the CAPS-2 severity score occurred during the continuation phase. Sertraline was well tolerated, with 8.6% of patients discontinuing due to adverse events. A high pretreatment CAPS-2 score (> 75) predicted a longer time to response and a greater likelihood that response occurred after 12 weeks of acute treatment.
CONCLUSION: The acute efficacy of sertraline is sustained in the vast majority of patients, and at least half of nonresponders to acute treatment will eventually respond to continued treatment.
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