Efficacy and safety of paroxetine treatment for chronic PTSD: A fixed-dose, placebo-controlled study

Objective: This study evaluated the efficacy and safety of paroxetine for t he treatment of patients with chronic posttraumatic stress disorder (PTSD). Method: Outpatients with chronic PTSD according to DSM-IV criteria and a sc ore of 50 or more on the Clinician-Administered PTSD Scale, part 2, were ra ndomly assigned to take placebo (N=186), 20 mg/day of paroxetine (N=183), o r 40 mg/day of paroxetine (N=182) for 12 weeks. Efficacy was assessed by ex amining the change in total score from baseline to endpoint on the Clinicia n-Administered PTSD Scale, part 2, and rates of response ("very much improv ed" or "much improved") for global improvement on the Clinical Global Impre ssion scale. Results: Paroxetine-treated patients in both dose groups demonstrated signi ficantly greater improvement on primary outcome measures compared to placeb o-treated patients in the intent-to-treat analysis. Moreover, paroxetine tr eatment resulted in statistically significant improvement compared to place bo on all three PTSD symptom clusters (reexperiencing, avoidance/numbing, a nd hyperarousal), social and occupational impairment, and comorbid depressi on. Paroxetine was effective for both men and women. Treatment response did not vary by trauma type time since trauma, or severity of baseline PTSD or depressive symptoms. Both doses were well tolerated. Conclusions: Doses of 20 and 40 mg/day of paroxetine are effective and well tolerated in the treatment of adults with chronic PTSD.