Article

Sertraline in the treatment of panic disorder - A multi-site, double-blind, placebo-controlled, fixed-dose investigation

Summit Research Network, Seattle, Seattle, Washington, United States
The British Journal of Psychiatry (Impact Factor: 7.34). 08/1998; 173:54-60. DOI: 10.1192/bjp.173.1.54
Source: PubMed

ABSTRACT This study compared the efficacy and safety of sertraline to placebo in treating panic disorder.
178 out-patients with panic disorder who exhibited at least four panic attacks during the four weeks prior to screening and three during the two weeks of lead-in were randomly assigned to 12 weeks of double-blind treatment with sertraline (50, 100 or 200 mg) or placebo.
Sertraline was superior to placebo in reducing the number of panic attacks, situational attacks, unexpected attacks, limited symptom attacks, and time spent worrying (all P < 0.01) and the Hamilton Anxiety Scale (P < 0.05), although Clinical Global Impression (Improvement) did not significantly differentiate groups at 12 weeks and at end-point. No serious adverse events were associated with sertraline. No dose relationship was found for adverse events; overall drop-out rates were not different for sertraline or placebo, although more sertraline-treated subjects discontinued for adverse events, typically early in the study. Only dry mouth and ejaculation failure (primarily ejaculation delay) were associated significantly with sertraline.
Sertraline was effective and safe in reducing panic attacks. Higher doses were no more effective than the 50 mg dose.

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Available from: Ward T Smith, Aug 03, 2015
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    • "An unexpected finding in this study was that sertraline alone did not fare better than placebo in improving symptoms of PD. This contrasts with three large randomized trials that demonstrated an advantage of sertraline over placebo drug in the acute treatment of PD (Londborg et al. 1998 ; Pohl et al. 1998 ; Pollack et al. 1998). Because negative results are not often reported by industry sponsors, we have no access to unpublished data and cannot compare our findings with other negative trials. "
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    ABSTRACT: Self-administered cognitive behavior therapy (SCBT) has been shown to be an effective alternative to therapist-delivered treatment for panic disorder (PD). However, it is unknown whether combining SCBT and antidepressants can improve treatment. This trial evaluated the efficacy of SCBT and sertraline, alone or in combination, in PD. Patients (n=251) were randomized to 12 weeks of either placebo drug, placebo drug plus SCBT, sertraline, or sertraline plus SCBT. Those who improved after 12 weeks of acute treatment received treatment for an additional 12 weeks. Outcome measures included core PD symptoms (panic attacks, anticipatory anxiety, agoraphobic avoidance), dysfunctional cognitions (fear of bodily sensations, agoraphobic cognitions), disability, and clinical global impression of severity and improvement. Efficacy data were analyzed using general and generalized linear mixed models. Primary analyses of trends over time revealed that sertraline/SCBT produced a significantly greater rate of decline in fear of bodily sensations compared to sertraline, placebo/SCBT and placebo. Trends in other outcomes were not significantly different over time. Secondary analyses of mean scores at week 12 revealed that sertraline/SCBT fared better on several outcomes than placebo, with improvement being maintained at the end of continuation treatment. Outcome did not differ between placebo and either sertraline monotherapy or placebo/SCBT. Moreover, few differences emerged between the active interventions. This trial suggests that sertraline combined with SCBT may be an effective treatment for PD. The study could not confirm the efficacy of sertraline monotherapy or SCBT without concomitant medication or therapist assistance in the treatment of PD.
    Psychological Medicine 05/2010; 41(2):373-83. DOI:10.1017/S0033291710000930 · 5.43 Impact Factor
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    • "Randomized clinical trials have demonstrated the effectiveness of fluoxetine [Michelson et al., 1998, 1999, 2001; Tiller et al., 1999], fluvoxamine [Black et al., 1993; den Boer, 1998; Sharp et al., 1997], paroxetine [Ballenger et al., 1998b; Oehrberg et al., 1995], sertraline [Londborg et al., 1998; Pohl et al., 1998; Pollack et al., 1998; Rapaport et al., 2001; Sheikh et al., 2000], citalopram [Wade et al., 1997], and escitalopram [Stahl et al., 2003] for panic disorder. Fluoxetine, paroxetine, and sertraline have received regulatory approval for panic disorder in the United States. "
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    ABSTRACT: To date, no large-scale, controlled trial comparing a serotonin-norepinephrine reuptake inhibitor and selective serotonin reuptake inhibitor with placebo for the treatment of panic disorder has been reported. This double-blind study compares the efficacy of venlafaxine extended-release (ER) and paroxetine with placebo. A total of 664 nondepressed adult outpatients who met DSM-IV criteria for panic disorder (with or without agoraphobia) were randomly assigned to 12 weeks of treatment with placebo or fixed-dose venlafaxine ER (75 mg/day or 150 mg/day), or paroxetine 40 mg/day. The primary measure was the percentage of patients free from full-symptom panic attacks, assessed with the Panic and Anticipatory Anxiety Scale (PAAS). Secondary measures included the Panic Disorder Severity Scale, Clinical Global Impressions--Severity (CGI-S) and--Improvement (CGI-I) scales; response (CGI-I rating of very much improved or much improved), remission (CGI-S rating of not at all ill or borderline ill and no PAAS full-symptom panic attacks); and measures of depression, anxiety, phobic fear and avoidance, anticipatory anxiety, functioning, and quality of life. Intent-to-treat, last observation carried forward analysis showed that mean improvement on most measures was greater with venlafaxine ER or paroxetine than with placebo. No significant differences were observed between active treatment groups. Panic-free rates at end point with active treatment ranged from 54% to 61%, compared with 35% for placebo. Approximately 75% of patients given active treatment were responders, and nearly 45% achieved remission. The placebo response rate was slightly above 55%, with remission near 25%. Adverse events were mild or moderate and similar between active treatment groups. Venlafaxine ER and paroxetine were effective and well tolerated in the treatment of panic disorder.
    Depression and Anxiety 01/2007; 24(1):1-14. DOI:10.1002/da.20218 · 4.29 Impact Factor
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    • "In a relapse prevention trial over 36 weeks, it was as effective as the TCA clomipramine (Lecrubier and Judge 1997) (A). Á Sertraline was also effective in DBPC studies (Londborg et al. 1998; Pohl et al. 1998; Pollack et al. 1998) and one non-inferiority comparator trial (Bandelow et al. 2004). In a relapse prevention study over 26 weeks, which followed open treatment over 1 year, sertraline was superior to placebo (Rapaport et al. 2001). "
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    ABSTRACT: In this report, recommendations for the pharmacological treatment of anxiety and obsessive-compulsive disorders are presented, based on available randomized, placebo- or comparator-controlled clinical studies. Selective serotonin reuptake inhibitors (SSRIs) are the first-line treatment for panic disorder. Tri2-cyclic antidepressants (TCAs) are equally effective, but they are less well tolerated than the SSRIs. In treatment-resistant cases, benzodiazepines like alprazolam may be used when the patient does not have a history of dependency and tolerance. Due to possible serious side effects and interactions with other drugs and food components, the irreversible monamine oxidase inhibitor (MAOI) phenelzine should be used only when first-line drugs have failed. In generalised anxiety disorder, venlafaxine and SSRIs can be recommended, while buspirone and imipramine may be alternatives. For social phobia, SSRIs are recommended for the first line, and MAOIs, moclobemide and benzodiazepines as second line. Obsessive-compulsive disorder is best treated with SSRIs or clomipramine.
    The World Journal of Biological Psychiatry 11/2002; 3(4):171-99. DOI:10.3109/15622970209150621 · 4.23 Impact Factor
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