Fluvoxamine-controlled release formulation for the treatment of generalized social anxiety disorder.
BACKGROUND
Generalized social anxiety disorder is a highly prevalent anxiety disorder with deleterious effects on social and family relationships, as well as work performance. We report the results of a multicenter, randomized, placebo-controlled trial comparing the efficacy, safety, and tolerability of fluvoxamine controlled release (CR) to placebo in patients with generalized social anxiety disorder.


METHODS
A total of 279 adult patients meeting all inclusion/exclusion criteria was recruited at 23 United States sites and randomly assigned to receive either fluvoxamine CR (100-300 mg/d) or placebo for 12 weeks. The dose could be increased, based on efficacy and tolerability, in increments of 50 mg/d at weekly intervals. The dosage remained constant during weeks 6 to 12.


RESULTS
Treatment with fluvoxamine CR resulted in statistically and clinically significant improvements in symptoms associated with generalized social anxiety disorder as early as week 4 on the Liebowitz Social Anxiety Scale and the Clinical Global Impression Scale Global Improvement, and at week 6 on the Sheehan Disability Scale, Clinical Global Impression Scale Severity of Illness and the Patient Global Impression of Improvement Scale. The most frequent adverse events reported by patients on fluvoxamine CR were headache, nausea, somnolence, and insomnia. No weight gain was observed for either treatment group, and at end point, there were no differences between treatments on overall sexual function, as measured by the Arizona Sexual Experience Scale.


CONCLUSIONS
Both physician and patient-rated scales indicate that fluvoxamine CR is effective and safe for the treatment of generalized social anxiety disorder.
Davidson
Jonathan
J
Department of Psychiatry, Duke University Medical Center, Trent Drive, 4th Floor, Room 4082B, Durham, NC 27710, USA. jonathan.davidson@duke.edu
Yaryura-Tobias
Jose
J
DuPont
Robert
R
Stallings
Loretta
L
Barbato
Luigi M
LM
van der Hoop
Roland Gerritsen
RG
Li
David
D
D000293:Adolescent; D000328:Adult; D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D001007:Anxiety / Q000188:drug therapy* / Q000523:psychology; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D016666:Fluvoxamine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D011594:Psychometrics; D018401:Sample Size; D012735:Sexual Dysfunction, Physiological / Q000139:chemically induced / Q000523:psychology; D012920:Social Behavior Disorders / Q000188:drug therapy* / Q000523:psychology; D016896:Treatment Outcome
D018687:Antidepressive Agents, Second-Generation; D003692:Delayed-Action Preparations; D016666:Fluvoxamine