Levetiracetam in social phobia: a placebo controlled pilot study. 2005

Wei Zhang, and Kathryn M Connor, and Jonathan R T Davidson
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, USA. wei.zhang@duke.edu

While serotonergic antidepressants are now established as first-line pharamcotherapy for generalized social anxiety disorder (SAD), other agents with different mechanisms have shown promise in treating SAD. The aim of this pilot study is to examine the efficacy and safety of levetiracetam (LEV), an anticonvulsant with calcium channel modulating properties, in treating SAD. Adult outpatients meeting DSM-IV criteria for SAD were randomly assigned (2:1) to double-blind treatment with either LEV (500-3000 mg/day) or placebo (PBO) for 7 weeks. The primary outcome measures were the change from baseline in the Brief Social Phobia Scale (BSPS) and response using the Clinical Global Impression of Improvement scale (CGI-I). The mean (SD) BSPS scores at baseline and endpoint were 45.4 (9.7) and 31.2 (19.7) for LEV (n=9), compared to 43.5 (8.4) and 37.8 (19.9) for PBO (n =7) (ITT; ns). Rates of response were 22% for LEV and 14% for PBO using the CGI-I. Using a BSPS response criterion (>30% reduction), response rates were 44% for LEV and 14% for PBO. The effect sizes of LEV relative to PBO were 0.33 for the BSPS and 0.50 for the LSAS. In summary, the results of this study, while negative on the pre-defined measures, suggest promise for LEV as a new treatment of SAD. Further work should be carried out with larger sample sizes and optimal dosing strategies of the drug.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010045 Outpatients Persons who receive ambulatory care at an outpatient department or clinic without room and board being provided. Out-patients,Out patients,Out-patient,Outpatient
D010698 Phobic Disorders Anxiety disorders in which the essential feature is persistent and irrational fear of a specific object, activity, or situation that the individual feels compelled to avoid. The individual recognizes the fear as excessive or unreasonable. Claustrophobia,Neuroses, Phobic,Phobia, School,Phobias,Phobic Neuroses,Scolionophobia,Disorder, Phobic,Phobia,Phobic Disorder,School Phobia
D010865 Pilot Projects Small-scale tests of methods and procedures to be used on a larger scale if the pilot study demonstrates that these methods and procedures can work. Pilot Studies,Pilot Study,Pilot Project,Project, Pilot,Projects, Pilot,Studies, Pilot,Study, Pilot
D010889 Piracetam A compound suggested to be both a nootropic and a neuroprotective agent. 2-Pyrrolidone-N-Acetamide,Avigilen,Axonyl,Cerebroforte,Cerepar N,Ciclofalina,Cuxabrain,Dinagen,Gabacet,Geram,Memo-Puren,Nootrop,Nootropil,Nootropyl,Normabraïn,Piracebral,Piracetam AbZ,Piracetam-RPh,Piracetrop,Pirazetam,Pyracetam,Pyramem,Sinapsan,UCB-6215,Memo Puren,Piracetam RPh,UCB 6215,UCB6215
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D011569 Psychiatric Status Rating Scales Standardized procedures utilizing rating scales or interview schedules carried out by health personnel for evaluating the degree of mental illness. Factor Construct Rating Scales (FCRS),Katz Adjustment Scales,Lorr's Inpatient Multidimensional Psychiatric Rating Scale,Wittenborn Scales,Edinburgh Postnatal Depression Scale,Mini International Neuropsychiatric Interview
D004305 Dose-Response Relationship, Drug The relationship between the dose of an administered drug and the response of the organism to the drug. Dose Response Relationship, Drug,Dose-Response Relationships, Drug,Drug Dose-Response Relationship,Drug Dose-Response Relationships,Relationship, Drug Dose-Response,Relationships, Drug Dose-Response
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked

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