Titre du document / Document title

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

Auteur(s) / Author(s)

SEEDAT Soraya ⁽¹⁾ ; STEIN Murray B. ⁽¹⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Anxiety and Traumatic Stress Disorders Program, Psychiatry Service, VA San Diego Healthcare System, San Diego, Calif., ETATS-UNIS

Résumé / Abstract

Background: 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 clonaze-pam 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 I 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.

Revue / Journal Title

The Journal of clinical psychiatry   ISSN 0160-6689 

Source / Source

2004, vol. 65, n^o2, pp. 244-248 [5 page(s) (article)] (20 ref.)

Langue / Language

Anglais

Editeur / Publisher

Physicians Postgraduate Press, Memphis, TN, ETATS-UNIS  (1978) (Revue)

Mots-clés anglais / English Keywords

Benzodiazepine derivatives ; Tranquillizer ; Sedative ; Piperidine derivatives ; Psychotropic ; Antidepressant agent ; Neurotransmitter ; Anxiety disorder ; Human ; Clonazepam ; Paroxetine ; Reuptake inhibitor ; Serotonin ; Randomized design ; Double blind study ; Generalized anxiety disorder ;

Mots-clés français / French Keywords

Benzodiazépine dérivé ; Tranquillisant ; Sédatif ; Pipéridine dérivé ; Psychotrope ; Antidépresseur ; Neurotransmetteur ; Trouble anxieux ; Homme ; Clonazépam ; Paroxétine ; Inhibiteur recapture ; Sérotonine ; Plan randomisé ; Etude double insu ; Trouble anxiété généralisée ;

Mots-clés espagnols / Spanish Keywords

Benzodiazepina derivado ; Tranquilizante ; Sedante ; Piperidina derivado ; Psicotropo ; Antidepresor ; Neurotransmisor ; Trastorno ansiedad ; Hombre ; Clonazepam ; Paroxetina ; Inhibidor recaptura ; Serotonina ; Plan aleatorizado ; Estudio doble ciego ; Trastorno ansiedad generalizada ;

Localisation / Location

INIST-CNRS, Cote INIST : 9069, 35400011930923.0160