Efficacy of sertraline in a 12-week trial for generalized anxiety disorder

University of Oslo, Kristiania (historical), Oslo, Norway
American Journal of Psychiatry (Impact Factor: 12.3). 10/2004; 161(9):1642-9. DOI: 10.1176/appi.ajp.161.9.1642
Source: PubMed


Sertraline's efficacy and tolerability in treating generalized anxiety disorder were evaluated.
Adult outpatients with DSM-IV generalized anxiety disorder and a total score of 18 or higher on the Hamilton Anxiety Rating Scale were eligible. After a 1-week single-blind placebo lead-in, patients were randomly assigned to 12 weeks of double-blind treatment with placebo (N=188, mean baseline anxiety score=25) or flexible doses (50-150 mg/day) of sertraline (N=182, mean anxiety score=25). The primary outcome measure was baseline-to-endpoint change in the Hamilton anxiety scale total score. A secondary efficacy measure was the Clinical Global Impression (CGI) improvement score; response was defined as a score of 2 or less.
Sertraline patients had significantly greater improvement than placebo patients on all efficacy measures at week 4. Analysis of covariance of the intent-to-treat group at endpoint (with the last observation carried forward) showed a significant difference in the decrease from baseline of the least-square mean total score on the Hamilton anxiety scale between sertraline (mean=11.7) and placebo (mean=8.0). Significantly greater endpoint improvement with sertraline than placebo was obtained for mean scores on the Hamilton anxiety scale psychic factor (6.7 versus 4.1) and somatic factor (5.0 versus 3.9). The rate of responders, based on CGI improvement and last observation carried forward, was significantly higher for sertraline (63%) than placebo (37%). Sertraline was well tolerated; 8% of patients versus 10% for placebo dropped out because of adverse events.
Sertraline appears to be efficacious and well tolerated in the treatment of generalized anxiety disorder.

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Available from: Christer Allgulander
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    • "Sertraline, along with the SSRIs escitalopram and paroxetine, is seen as a first-line pharmacologic treatment for GAD [12]. Randomised, placebo controlled trials have found sertraline efficacious for GAD in adults [13,14], children and adolescents [15,16]. The treatment period ranged from 9 to 12 weeks in these pharmacological trials. "
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    • "Although there is a paucity of randomized , controlled studies examining treatment strategies for patients with symptomatic GAD following first-line therapy, case-report data suggest that combination therapy with antidepressants and benzodiazepines may be effective (Pollack, 2001). SSRIs and SNRIs have a delayed onset of action (2–4 wk) (Allgulander et al. 2004 ; Gelenberg et al. 2000 ; Rickels et al. 2003), thus short-term adjunct benzodiazepine therapy is common when initiating treatment with these agents. For benzodiazepines, cognitive effects , rebound anxiety, withdrawal symptoms, and abuse potential, limit their use in clinical practice (Chouinard, 2004), while SSRIs and SNRIs are associated with sexual dysfunction (Bandelow et al. 2008) and discontinuation effects (Fava et al. 2007). "
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    • "; escitalopram n ϭ3 [Davidson et al., 2004; Goodman et al., 2005 and unpublished data from Forest Laboratories]; sertraline n ϭ2 [Rynn et al., 2001; Allgulander et al., 2004]; and fluvoxamine n ϭ1 [Walkup et al., 2001]). Of three AH studies (Ferreri et al., 1995; Lader and Scotto, 1998; Llorca et al., 2002), two included active comparators: buspirone (Lader and Scotto, 1998) and bromazepam (Llorca et al., 2002), although the efficacy data for bromazepam was not provided and, hence, not included in the analysis . "
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