Article

Maintenance therapy with fluoxetine in posttraumatic stress disorder: a placebo-controlled discontinuation study.

Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, USA.
Journal of Clinical Psychopharmacology (Impact Factor: 3.76). 05/2005; 25(2):166-9. DOI: 10.1097/01.jcp.0000155817.21467.6c
Source: PubMed

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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    • "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. "
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    • "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 "
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