Fluoxetine, comprehensive cognitive behavioral therapy, and placebo in generalized social phobia.
BACKGROUND
Generalized social phobia is common, persistent, and disabling and is often treated with selective serotonin reuptake inhibitor drugs or cognitive behavioral therapy.


OBJECTIVE
We compared fluoxetine (FLU), comprehensive cognitive behavioral group therapy (CCBT), placebo (PBO), and the combinations of CCBT/FLU and CCBT/PBO.


METHODS
Randomized, double-blind, placebo-controlled trial.


METHODS
Two academic outpatient psychiatric centers.


METHODS
Subjects meeting a primary diagnosis of generalized social phobia were recruited via advertisement. Seven hundred twenty-two were screened, and 295 were randomized and available for inclusion in an intention-to-treat efficacy analysis; 156 (52.9%) were male, 226 (76.3%) were white, and mean age was 37.1 years.


METHODS
Treatment lasted for 14 weeks. Fluoxetine and PBO were administered at doses from 10 mg/d to 60 mg/d (or equivalent). Group comprehensive cognitive behavioral therapy was administered weekly for 14 sessions.


METHODS
An independent blinded evaluator assessed response with the Brief Social Phobia Scale and Clinical Global Impressions scales as primary outcomes. A videotaped behavioral assessment served as a secondary outcome, using the Subjective Units of Distress Scale. Adverse effects were measured by self-rating. Each treatment was compared by means of chi2 tests and piecewise linear mixed-effects models.


RESULTS
Clinical Global Impressions scales response rates in the intention-to-treat sample were 29 (50.9%) (FLU), 31 (51.7%) (CCBT), 32 (54.2%) (CCBT/FLU), 30 (50.8%) (CCBT/PBO), and 19 (31.7%) (PBO), with all treatments being significantly better than PBO. On the Brief Social Phobia Scale, all active treatments were superior to PBO. In the linear mixed-effects models analysis, FLU was more effective than CCBT/FLU, CCBT/PBO, and PBO at week 4; CCBT was also more effective than CCBT/FLU and CCBT/PBO. By the final visit, all active treatments were superior to PBO but did not differ from each other. Site effects were found for the Subjective Units of Distress Scale assessment, with FLU and CCBT/FLU superior to PBO at Duke University Medical Center, Durham, NC. Treatments were well tolerated.


CONCLUSIONS
All active treatments were superior to PBO on primary outcomes. Combined treatment did not yield any further advantage. Notwithstanding the benefits of treatment, many patients remained symptomatic after 14 weeks.
Davidson
Jonathan R T
JR
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, USA. jonathan.davidson@duke.edu
Foa
Edna B
EB
Huppert
Jonathan D
JD
Keefe
Francis J
FJ
Franklin
Martin E
ME
Compton
Jill S
JS
Zhao
Ning
N
Connor
Kathryn M
KM
Lynch
Thomas R
TR
Gadde
Kishore M
KM
D000328:Adult; D000553:Ambulatory Care; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016014:Linear Models; D008297:Male; D010698:Phobic Disorders / Q000188:drug therapy / Q000523:psychology / Q000628:therapy*; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D011743:Pyrimidines / Q000627:therapeutic use*; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome; D014743:Videotape Recording
D010919:Placebos; D011743:Pyrimidines; D017367:Selective Serotonin Reuptake Inhibitors; C001247:fluoxydine