levetiracetam and Phobic-Disorders

This multicenter, double-blind, placebo-controlled, 2-arm, parallel-group study was carried out to determine the effectiveness and safety of the novel anticonvulsant levetiracetam for the treatment of generalized social anxiety disorder (GSAD).. After a 1-week, single-blind, placebo run-in period, 217 adult outpatients meeting DSM-IV criteria for social anxiety disorder, generalized type, were randomly assigned (1:1) to 12 weeks of double-blind treatment with either levetiracetam (n = 111) or placebo (n = 106). Participants were required to have scores of >or= 60 on the Liebowitz Social Anxiety Scale (LSAS) and a total score of or= 30% reduction in LSAS score) were similar with 41.3% (levetiracetam) and 46.6% (placebo). No significant between-group differences were found on secondary outcome measures, which included changes in Sheehan Disability Scale, Clinical Global Impression of Change, and HDRS scores.. Although well-tolerated, levetiracetam failed to separate from placebo in this trial for the treatment of moderate to severe GSAD.

Topics: Adult; Anti-Anxiety Agents; Double-Blind Method; Female; Humans; Levetiracetam; Male; Phobic Disorders; Piracetam; Psychiatric Status Rating Scales

Body dysmorphic disorder (BDD) is an often severe disorder, but few treatment studies have been conducted.. This pilot study explored the efficacy and safety of the antiepileptic medication levetiracetam for BDD.. Seventeen subjects with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition BDD participated in a 12-week open-label levetiracetam trial. Subjects were assessed at regular intervals with standard measures.. In intent-to-treat analyses, scores on the Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS), the primary outcome measure, decreased from 32.5+/-4.7 at baseline to 21.5+/-11.0 at endpoint (P<.001). Approximately 60% (n=9) of subjects were responders (>30% decrease on the BDD-YBOCS). The mean time to response was 4.6+/-2.8 (range: 2-10) weeks. Scores also significantly improved on the Brown Assessment of Beliefs Scale, the Hamilton Rating Scale for Depression, the Global Assessment of Functioning Scale, and the Social and Occupational Functioning Assessment Scale. Scores did not significantly improve on the Quality of Life Enjoyment and Satisfaction Questionnaire, the Beck Anxiety Inventory, or the Social Phobia Inventory. The mean endpoint dose of levetiracetam was 2,044.1+/-1,065.2 (range: 250-3,000) mg/day, and it was relatively well-tolerated.. Randomized, double-blind placebo-controlled studies of levetiracetam for BDD are needed to confirm these preliminary findings.

Topics: Adult; Anticonvulsants; Anxiety; Body Image; Dose-Response Relationship, Drug; Female; Humans; Levetiracetam; Male; Middle Aged; Personal Satisfaction; Phobic Disorders; Pilot Projects; Piracetam; Prospective Studies; Psychiatric Status Rating Scales; Quality of Life; Self Concept; Somatoform Disorders; Surveys and Questionnaires; Treatment Outcome; Young Adult

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.

Topics: Adult; Anticonvulsants; Dose-Response Relationship, Drug; Double-Blind Method; Female; Headache; Humans; Levetiracetam; Male; Middle Aged; Outpatients; Phobic Disorders; Pilot Projects; Piracetam; Placebos; Psychiatric Status Rating Scales; Sleep Stages; Treatment Outcome

Social anxiety disorder is a disabling condition characterized by excessive fear and avoidance of social and performance situations. While a variety of effective pharmacotherapies exists, many patients do not fully respond to or tolerate available agents. Preclinical and early clinical experience with levetiracetam, a novel anticonvulsant agent, suggests that levetiracetam has anxiolytic properties and a favorable adverse event profile. Levetiracetam thus warrants systematic evaluation as a treatment option for anxiety disorders.. Twenty adult outpatients who were recruited through advertisement and clinical referral and who met DSM-IV criteria for social anxiety disorder, generalized type, participated in this 8-week open-label, flexible-dose study from November 2002 to December 2003. Participants were required to have scores of >/= 50 on the Liebowitz Social Anxiety Scale (LSAS) and >/= 4 on the Clinical Global Impressions-Severity of Illness scale (CGI-S) at baseline. The presence of comorbid depression and anxiety disorders were permitted as long as social anxiety disorder was the primary disorder. Levetiracetam was initiated at 250 mg/day for the first week and flexibly titrated up to a maximum of 3000 mg/day (1500 mg b.i.d.). The primary outcome measure was change in the LSAS score at endpoint.. There was a clinically significant 20.5-point decrease in LSAS scores in the intent-to-treat, last-observation-carried-forward analysis (t = 3.1; p <.01, N = 20). There were also significant reductions in CGI-S (p <.01) and Hamilton Rating Scale for Anxiety (p <.02) scores.. This pilot study supports the safety and potential efficacy of a novel agent, levetiracetam, for the treatment of social anxiety disorder. Larger controlled trials are warranted to confirm these results.

Topics: Adult; Ambulatory Care; Anticonvulsants; Drug Administration Schedule; Female; Humans; Levetiracetam; Male; Phobic Disorders; Pilot Projects; Piracetam; Prospective Studies; Psychiatric Status Rating Scales; Severity of Illness Index; Treatment Outcome