An open-label study of levetiracetam for the treatment of social anxiety disorder.
OBJECTIVE
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Simon
Naomi M
NM
Center for Anxiety and Traumatic Stress Related Disorders, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA.
Worthington
John J
JJ
Doyle
Alicia C
AC
Hoge
Elizabeth A
EA
Kinrys
Gustavo
G
Fischmann
Diana
D
Link
Nathaniel
N
Pollack
Mark H
MH
D000328:Adult; D000553:Ambulatory Care; D000927:Anticonvulsants / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D010698:Phobic Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D010865:Pilot Projects; D010889:Piracetam / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use*; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam