A placebo-controlled trial of phenelzine, cognitive behavioral group therapy, and their combination for social anxiety disorder.
BACKGROUND
Medication and cognitive behavioral treatment are the best-established treatments for social anxiety disorder, yet many individuals remain symptomatic after treatment.


OBJECTIVE
To determine whether combined medication and cognitive behavioral treatment is superior to either monotherapy or pill placebo.


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


METHODS
Research clinics at Columbia University and Temple University.


METHODS
One hundred twenty-eight individuals with a primary DSM-IV diagnosis of social anxiety disorder.


METHODS
Cognitive behavioral group therapy (CBGT), phenelzine sulfate, pill placebo, and combined CBGT plus phenelzine.


METHODS
Liebowitz Social Anxiety Scale and Clinical Global Impression (CGI) scale scores at weeks 12 and 24.


RESULTS
Linear mixed-effects models showed a specific order of effects, with steepest reductions in Liebowitz Social Anxiety Scale scores for the combined group, followed by the monotherapies, and the least reduction in the placebo group (Williams test = 4.97, P < .01). The CGI response rates in the intention-to-treat sample at week 12 were 9 of 27 (33.3%) (placebo), 16 of 34 (47.1%) (CBGT), 19 of 35 (54.3%) (phenelzine), and 23 of 32 (71.9%) (combined treatment) (chi(2)(1) = 8.76, P < .01). Corresponding remission rates (CGI = 1) were 2 of 27 (7.4%), 3 of 34 (8.8%), 8 of 35 (22.9%), and 15 of 32 (46.9%) (chi(2)(1) = 15.92, P < .01). At week 24, response rates were 9 of 27 (33.3%), 18 of 34 (52.9%), 17 of 35 (48.6%), and 25 of 32 (78.1%) (chi(2)(1) = 12.02, P = .001). Remission rates were 4 of 27 (14.8%), 8 of 34 (23.5%), 9 of 35 (25.7%), and 17 of 32 (53.1%) (chi(2)(1) = 10.72, P = .001).


CONCLUSIONS
Combined phenelzine and CBGT treatment is superior to either treatment alone and to placebo on dimensional measures and on rates of response and remission.
Blanco
Carlos
C
Department of Psychiatry, New York State Psychiatric Institute, College of Physicians and Surgeons of Columbia University,1051 Riverside Dr, Box 69, New York, NY 10032, USA. cb255@columbia.edu
Heimberg
Richard G
RG
Schneier
Franklin R
FR
Fresco
David M
DM
Chen
Henian
H
Turk
Cynthia L
CL
Vermes
Donna
D
Erwin
Brigette A
BA
Schmidt
Andrew B
AB
Juster
Harlan R
HR
Campeas
Raphael
R
Liebowitz
Michael R
MR
D000293:Adolescent; D000328:Adult; D000368:Aged; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003131:Combined Modality Therapy; D039721:Diagnostic and Statistical Manual of Mental Disorders; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008996:Monoamine Oxidase Inhibitors / Q000627:therapeutic use*; D010624:Phenelzine / Q000627:therapeutic use*; D010698:Phobic Disorders / Q000175:diagnosis / Q000188:drug therapy / Q000628:therapy*; D010919:Placebos; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D011594:Psychometrics; D011615:Psychotherapy, Group / Q000379:methods; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D008996:Monoamine Oxidase Inhibitors; D010919:Placebos; D010624:Phenelzine