Maintenance therapy with fluoxetine in posttraumatic stress disorder: a placebo-controlled discontinuation study.
ABSTRACT The effect of fluoxetine (FLU) in posttraumatic stress disorder was studied in a one-year trial. Subjects received open-label treatment for 6 months, followed by double-blind randomized treatment with FLU or placebo (PBO) for 6 months. Rates of relapse were compared using the Clinical Global Impressions of Improvement. One hundred twenty-three subjects entered open-label treatment, of whom 114 returned at least once. Sixty-two subjects were randomized to receive FLU or PBO, of whom 57 returned at least once and were analyzed. The dose of FLU ranged from 10 to 60 mg/d; at randomization, mean doses were 48.6 and 42.1 mg for FLU and PBO groups. Rates of relapse were 22% for FLU versus 50% for PBO (P = 0.02), and time to relapse on FLU was longer than for PBO (P = 0.02, log-rank statistic). The odds ratio for relapse on PBO relative to FLU was 3.50. No significant differences were found on other measures. Fluoxetine was well tolerated during double-blind treatment.
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ABSTRACT: Post-traumatic stress disorder (PTSD) is a prevalent and disabling disorder. Recognition of neurobiological abnormalities associated with this condition suggests the potential efficacy of medication in its treatment. Nevertheless, questions regarding the efficacy of medications remain, despite general endorsement by clinical practice guidelines of selective serotonin reuptake inhibitors (SSRIs) as first-line agents in treating PTSD. This paper reviews evidence from randomized controlled trials (RCTs) for the efficacy of acute and long-term pharmacotherapy for PTSD, including the treatment of refractory PTSD. In addition, we conducted a systematic meta-analysis to compare the efficacy of different medications in treating PTSD. The effects of methodological study features (including year of publication, duration, number of centres) and sample characteristics (proportion of combat veterans, gender composition) were also tested. The largest body of evidence for short- and long-term efficacy of medication currently exists for SSRIs, with promising initial findings for the selective noradrenergic reuptake inhibitor venlafaxine and the atypical antipsychotic risperidone. Treatment effect was predicted by number of centres and recency of the study, with little evidence that sample characteristics predicted response. Evidence for the effectiveness of benzodiazepines is lacking, despite their continued use in clinical practice. Finally, the α1 antagonist prazosin and the atypical antipsychotics show some efficacy in treatment-resistant PTSD. Adequately powered trials that are designed in accordance with best-practice guidelines are required to provide conclusive evidence of clinically relevant differences in efficacy between agents in treating PTSD, and to help estimate clinical and methodological predictors of treatment response.The International Journal of Neuropsychopharmacology 07/2011; 15(6):825-40. DOI:10.1017/S1461145711001209 · 5.26 Impact Factor
- Journal of Contemporary Psychotherapy 06/2011; 42(2). DOI:10.1007/s10879-011-9195-z
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ABSTRACT: Meta-analysis was conducted to examine dropout predictors and differences between SSRIs and placebo in randomized clinical trials (RCTs) of PTSD. Studies systematically located were SSRI versus placebo double blind RCTs of PTSD DSM diagnosis published between 1991 and 2008. Fourteen RCTs (n = 2815) met the inclusion criteria with an average duration of 10.8 weeks. Dropout rates were: 331 of 1111 (29.8%) among placebo arm and 513 of 1704 (30.3%) among SSRI participants. Random effects modeling showed that the dropout rates of SSRIs and placebo did not differ (OR = 1.05, 95% CI = 0.82-1.34), although favored SSRIs among civilian traumas (OR = 2.52, 95% CI = 1.11-5.7). Mixed effects modeling showed dropout was predicted by mixed trauma in the placebo arms, and duration and mean dose across treatments. With the exception of civilian trauma, SSRIs dropout rates were slightly lower than those of placebo. Formulae are available to guide the prediction of dropout.The Journal of nervous and mental disease 02/2010; 198(2):116-24. DOI:10.1097/NMD.0b013e3181cc41b6 · 1.81 Impact Factor