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CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
Posttraumatic stress disorder and quality of life: results across 64 weeks of sertraline treatment.
Journal of Clinical Psychiatry 2002 January
OBJECTIVE: The goal of the current study was to characterize the quality of life (QOL) and functional impairment associated with posttraumatic stress disorder (PTSD) and to report the QOL/functional response over the course of long-term treatment.
METHOD: QOL and psychosocial functioning were analyzed in 359 randomly assigned patients across a 3-phase study of sertraline in the treatment of chronic DSM-III-R-defined PTSD: (1) 12 weeks of double-blind, placebo-controlled acute treatment with sertraline in flexible doses of 50 to 200 mg/day, (2) 24 weeks of open-label continuation treatment with sertraline among all study completers (regardless of initial study drug assignment or endpoint responder status), and (3) 28 weeks of double-blind, placebo-controlled maintenance treatment with sertraline in continuation phase responders. Assessments included the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), emotional role functioning and mental health subscales of the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), as well as the occupational and social functioning items on the Clinician-Administered PTSD Scale, Part 2 (CAPS-2).
RESULTS: At acute phase baseline, QOL was significantly impaired as reflected by a mean Q-LES-Q score of 56% of the total possible score and a CAPS-2 social/occupational impairment composite score of 4.4. Sertraline treatment was associated with marked improvement on all QOL/functional measurements: at the end of the acute treatment phase, 58% of responders on treatment with sertraline had achieved Q-LES-Q total scores within 10% of community norms. Twenty-four weeks of continuation treatment led to an additional 20% improvement in QOL and measures of functioning. Double-blind discontinuation of sertraline resulted in recurrence of PTSD symptoms and a worsening of QOL and functional measures, although the degree of exacerbation in symptomatology and psychosocial impairment was notably less than at study entry.
CONCLUSION: Sertraline treatment of chronic PTSD is associated with rapid improvement in quality of life that is progressive and sustained over the course of more than 1 year of treatment.
METHOD: QOL and psychosocial functioning were analyzed in 359 randomly assigned patients across a 3-phase study of sertraline in the treatment of chronic DSM-III-R-defined PTSD: (1) 12 weeks of double-blind, placebo-controlled acute treatment with sertraline in flexible doses of 50 to 200 mg/day, (2) 24 weeks of open-label continuation treatment with sertraline among all study completers (regardless of initial study drug assignment or endpoint responder status), and (3) 28 weeks of double-blind, placebo-controlled maintenance treatment with sertraline in continuation phase responders. Assessments included the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), emotional role functioning and mental health subscales of the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), as well as the occupational and social functioning items on the Clinician-Administered PTSD Scale, Part 2 (CAPS-2).
RESULTS: At acute phase baseline, QOL was significantly impaired as reflected by a mean Q-LES-Q score of 56% of the total possible score and a CAPS-2 social/occupational impairment composite score of 4.4. Sertraline treatment was associated with marked improvement on all QOL/functional measurements: at the end of the acute treatment phase, 58% of responders on treatment with sertraline had achieved Q-LES-Q total scores within 10% of community norms. Twenty-four weeks of continuation treatment led to an additional 20% improvement in QOL and measures of functioning. Double-blind discontinuation of sertraline resulted in recurrence of PTSD symptoms and a worsening of QOL and functional measures, although the degree of exacerbation in symptomatology and psychosocial impairment was notably less than at study entry.
CONCLUSION: Sertraline treatment of chronic PTSD is associated with rapid improvement in quality of life that is progressive and sustained over the course of more than 1 year of treatment.
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