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A pilot study of clonazepam versus psychodynamic group therapy plus clonazepam in the treatment of generalized social anxiety disorder

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A pilot study of clonazepam versus psychodynamic group therapy plus clonazepam in the treatment of generalized social anxiety disorder
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   1A Pilot Study of Clonazepam versus Psychodynamic Group Treatment plus Clonazepam in the Treatment of Generalized Social Anxiety Disorder Daniela Z.Knijnik, M.D.; Carlos Blanco, M.D., Ph.D.; Giovanni A. Salum Jr.; Carolina Moraes, M.D.; Clarissa K.Mombach, M.D.; Ellen A. Almeida, M.D.; Marília P. Pereira, M.D.; Atahualpa P. Strapasson; Gisele G. Manfro, M.D., Ph.D; and Cláudio L. Eizirik, M.D., Ph.D.  From the Postgraduate Program in Medical Science, Psychiatry, Federal University of Rio Grande do Sul (Drs. Knijnik, Manfro and Eizirik); the Anxiety  Disorder Program, Hospital de Clínicas de Porto Alegre (Drs. Knijnik, Salum Jr.,  Moraes, Mombach, Almeida, Pereira, Strapasson, Manfro); the Department of  Psychiatry, Federal University of Rio Grande do Sul (Drs. Manfro and Eizirik), Porto  Alegre, Brazil and Columbia University and New York State Psychiatric Institute, NY (Dr. Blanco). This research was partially supported by the Fundaç ão  de Incentivo à  Pesquisa e  Eventos (FIPE) at the Hospital de Clínicas de Porto Alegre, Brazil, by Roche  Pharmaceuticals, Porto Alegre, Brazil (Dr. Knijnik), and by NIH grants DA00482 and  DA019606 (Dr. Blanco). The authors report no additional financial affiliations or other relationships relevant to the subject of this article. Corresponding author and reprints:  Daniela Zippin Knijnik, M.D., Rua Hilário Ribeiro 202 / 503, Porto Alegre, RS, Brazil 90510-040 (e-mail: knijnikd@terra.com.br).   2   3 ABSTRACT Objective: Psychodynamic Group Therapy (PGT) and clonazepam have proven efficacious in reducing symptoms of generalized social anxiety disorder (GSAD). Despite their efficacy, many individuals remain symptomatic after treatment with PGT or clonazepam as monotherapy. The goal of this study was to compare the efficacy of PGT plus clonazepam administered concurrently versus clonazepam alone for the treatment of GSAD.  Method: Fifty-eight adult outpatients with a diagnosis of GSAD according to DSM-IV criteria, participated in a 12-week randomized clinical trial: 29 underwent a combined treatment (PGT plus clonazepam) and 29 took clonazepam alone. The Clinical Global Impression-Improvement (CGI-I) scale was the primary efficacy measure. Secondary efficacy measures included the Liebowitz Social Anxiety Scale (LSAS) total score, the World Health Organization Instrument to Assess Quality of Life-Bref (Whoqol-bref   )  scale and the Beck Depression Inventory (BDI). The trial was conducted between March and November 2005.  Results:  CGI-I data from 57  patients (intent-to-treat population) showed that the PGT plus clonazepam group  presented significantly greater improvement than clonazepam alone (p=0.043). Using a CGI-I of 1 or 2 as the criterion for response, the difference in the response rate of PGT  plus clonazepam versus clonazepam alone approached significance (79.3% vs. 53.6%, respectively; p=0.052). Conclusion: This study is the first to compare combined PGT and medication versus medication alone in the treatment of GSAD. Our study suggests that addition of PGT may be a promising augmentation strategy for clonazepam treatment of GSAD. KEY WORDS: Social Anxiety Disorder; Social Phobia; Augmentation Strategies; Psychotherapy; Clonazepam   4   5 INTRODUCTION Social anxiety disorder (SAD), also known as social phobia, is a chronic  psychiatric disorder of adolescence onset with lifetime consequences and significant economic costs 1-3 . It interferes with the normal development of social and interpersonal relationships, often leading to long-term disability in the social, work, and family domains, and decreased quality of life 4-7 . Although spontaneous recovery is possible, it occurs over many years and only in about half of the cases 8 . In addition, SAD is a risk factor for the development of other comorbid anxiety, substance use and mood disorders (particularly major depressive disorder) suicidal ideation and occasionally, suicide 9-12 . Early recognition and treatment of SAD have the potential to reduce the risk of other  psychiatric disorders later in life 13 . SAD is estimated to affect 6-15% of individuals in the community at some point in their lives. The lifetime prevalence is similar in the United States (13%) 3;14 ,Europe (14%) 11  and Brazil (12.8%) 15 , making it the most common anxiety disorder and one of the most common psychiatric disorders 14;16 . About half that prevalence represents individuals who have the generalized type of the disorder (generalized social anxiety disorder [GSAD]), characterized by fear and avoidance encompassing several social situations 8 . Treatment strategies for SAD have focused on psychotherapy, primarily cognitive-behavioral therapy (CBT) and pharmacotherapy 17-20 . Controlled trials and meta-analyses suggest similar benefits from both CBT and pharmacotherapy 21-25  in the short-term treatment of SAD. In controlled clinical trials, monoamine oxidase
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