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.
- SourceAvailable from: Dan J. Stein
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- "Patients who were randomized to fluoxetine continued to improve significantly on the clinical and PTSD severity scores, as well as in anxiety and depression symptoms. Davidson et al. (2005), randomized 62 subjects to 6 months continuation treatment with fluoxetine or placebo after the same period of open-label treatment (max. 60 mg/d) with fluoxetine. "
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
- "At least 34 randomized clinical pharmacology trials have been conducted since the diagnosis of PTSD was developed in the early 1980s (Friedman et al. 2009), and, though the majority of studies suggest that medications for PTSD are more effective than placebos, others have failed to show significant effects (Davidson et al. 2005; Friedman et al. 2007; Zohar et al. 2002). Furthermore, although most patients experience a reduction in symptoms, the long term effectiveness of pharmacotherapies for PTSD are limited, as only 30% achieve complete remission of their symptoms after three months of treatment compared to 65–79% with cognitivebehavioral approaches (Foa et al. 1999), and several studies have shown that discontinuation of these drugs is likely to result in relapse (Davidson et al. 2005; Martenyi and Soldatenkova 2006). Due to the oftentimes refractory nature of this disorder, different avenues of advancing treatment have been proposed (Cukor et al. 2009), one of them being the notion of combining biological and psychological interventions. "
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- "2003 ; Roy - Byrne et al . , 2005 ) , ( 2 ) less than 10 people per treatment arm ( Hertzberg et al . , 2000 ) , ( 3 ) primary outcome measure other than acute improvement ( i . e . , maintenance , relapse prevention , aug - mentation treatment , continuation study ) ( Davidson et al . , 2001a ; Martenyi et al . , 2002a ; Rapaport et al . , 2002 ; Davidson et al . , 2005 ; Martenyi and Soldatenkova , 2006 ; Rothbaum et al . , 2006 ; Simon et al . , 2008 ) , or ( 4 ) comorbidity of alcohol and drug abuse / dependence ( Brady et al . , 1995 ; Brady et al . , 2005 ; Back et al . , 2006 ) . Thus using a systematic study selection strategy , ( Moher et al . , 1999 ) illustrated in Figure 1 , 76 studies were "
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