Double-blind, placebo-controlled assessment of combined clonazepam with paroxetine compared with paroxetine monotherapy for generalized social anxiety disorder

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dc.contributor.authorSeedat S.
dc.contributor.authorStein M.B.
dc.date.accessioned2011-05-15T16:01:56Z
dc.date.available2011-05-15T16:01:56Z
dc.date.issued2004
dc.description.abstractBackground: Generalized social anxiety disorder (GSAD) is a pervasive form of social anxiety that affects approximately 5% of persons in the community. Among evidence-based pharmacologic treatments for the disorder, selective serotonin reuptake inhibitors (SSRIs) have become widely used and are known to be efficacious. Monotherapy with the benzodiazepine clonazepam is also efficacious for GSAD, but the adjunctive use of clonazepam with an SSRI to potentially improve outcomes has not been studied to date. Method: Twenty-eight patients (22 men and 6 women) with DSM-IV-defined GSAD were randomly assigned to receive double-blind clonazepam (or placebo), 1.0 to 2.0 mg/day (divided b.i.d.) along with open-label paroxetine, 20 to 40 mg/day, for 10 weeks. A 2-week taper of double-blind medication was followed by an additional 8 weeks of open-label paroxetine treatment (during which the dose of paroxetine could be increased to a maximum of 50 mg/day). Twenty-three patients (82%) met DSM-IV criteria for avoidant personality disorder. The patients' mean ± SD age was 31.2 ± 7.7 years, and their mean duration of illness was 12.1 ± 5.8 years. Data were gathered from August 2001 to April 2002. Results: Nineteen (68%) of 28 patients completed treatment. At the end of the 10-week double-blind treatment, there was a trend (p < .06) favoring the paroxetine/clonazepam group, who had a 79% response rate (Clinical Global Impressions-Global Improvement scale [CGI-I] score of 1 or 2) compared with a 43% response rate for the paroxetine/placebo group. However, no significant differences on other outcome measures were noted between the 2 groups in an intent-to-treat analysis, in terms of either very early (2-4 weeks) or not as early (5-10 weeks) responses during treatment. Dropout rates due to adverse events were rare (1 patient in each group), indicating that the paroxetine/clonazepam combination was well tolerated. Conclusion: Coadministration of clonazepam with an SSRI, in contrast to findings in panic disorder, did not lead to more rapid resolution of symptoms in GSAD. On the other hand, there is some evidence that the clonazepam-added group had superior global outcomes (e.g., as measured on the CGI-I), although power to detect such differences in this study was small. These observations suggest that a role for adjunctive benzodiazepines in patients with GSAD (e.g., for augmenting SSRI partial response or nonresponse) is deserving of further controlled investigation. © Copyright 2004 Physicians Postgraduate Press, Inc.
dc.description.versionArticle
dc.identifier.citationJournal of Clinical Psychiatry
dc.identifier.citation65
dc.identifier.citation2
dc.identifier.issn1606689
dc.identifier.urihttp://hdl.handle.net/10019.1/12230
dc.subjectanxiolytic agent
dc.subjectclonazepam
dc.subjectparoxetine
dc.subjectserotonin uptake inhibitor
dc.subjectadult
dc.subjectarticle
dc.subjectclinical trial
dc.subjectcomparative study
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdose response
dc.subjectdouble blind procedure
dc.subjectdrug administration
dc.subjectdrug combination
dc.subjectfemale
dc.subjecthuman
dc.subjectmale
dc.subjectpersonality test
dc.subjectphobia
dc.subjectpsychological aspect
dc.subjectrandomized controlled trial
dc.subjecttreatment outcome
dc.subjectAdult
dc.subjectAnti-Anxiety Agents
dc.subjectClonazepam
dc.subjectDose-Response Relationship, Drug
dc.subjectDouble-Blind Method
dc.subjectDrug Administration Schedule
dc.subjectDrug Therapy, Combination
dc.subjectFemale
dc.subjectHumans
dc.subjectMale
dc.subjectParoxetine
dc.subjectPersonality Assessment
dc.subjectPhobic Disorders
dc.subjectSerotonin Uptake Inhibitors
dc.subjectTreatment Outcome
dc.titleDouble-blind, placebo-controlled assessment of combined clonazepam with paroxetine compared with paroxetine monotherapy for generalized social anxiety disorder
dc.typeArticle
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