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document
Sertraline treatment of generalized social phobia : a 20-week , double-blind , placebo-controlled study . OBJECTIVE The authors evaluated the efficacy , safety , and tolerability of sertraline , a selective serotonin reuptake inhibitor , in the treatment of generalized social phobia . METHOD Adult outpatients with generalized social phobia ( N=204 ) from 10 Canadian centers were randomly assigned to receive sertraline or placebo in a 2:1 ratio for a 20-week double-blind study following a 1-week , single-blind , placebo run-in . The initial dose of sertraline was 50 mg/day with increases of 50 mg/day every 3 weeks permitted after the fourth week of treatment ( dosing was flexible up to a maximum of 200 mg/day ) . Primary efficacy assessments were the percentage of patients rated much or very much improved on the Clinical Global Impression ( CGI ) improvement item and the mean changes from baseline to study endpoint in total score on the social phobia subscale of the Marks Fear Questionnaire and total score on the Brief Social Phobia Scale . RESULTS In intent-to-treat endpoint analyses of 203 of the patients , significantly more of the 134 patients given sertraline ( N=71 [ 53 % ] ) than of the 69 patients receiving placebo ( N=20 [ 29 % ] ) were considered responders according to their CGI improvement scores at the end of treatment . The mean reductions in the social phobia subscale of the Marks Fear Questionnaire and in the total score on the Brief Social Phobia Scale were 32.6 % and 34.3 % in the sertraline group and 10.8 % and 18.6 % in the placebo group , respectively . Analysis of covariance showed superiority of sertraline over placebo on all primary and secondary efficacy measures . Sertraline was well tolerated : 103 ( 76 % ) of the 135 sertraline-treated patients and 54 ( 78 % ) of the 69 placebo-treated patients completed the study . CONCLUSIONS Sertraline is an effective treatment for patients with generalized social phobia .
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Intervention_Pharmacological
Sertraline
5212
Intervention_Pharmacological
sertraline
5213
Intervention_Pharmacological
sertraline
5214
Intervention_Control
placebo
5215
Intervention_Pharmacological
sertraline
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Intervention_Pharmacological
sertraline
5217
Intervention_Control
placebo
5218
Intervention_Pharmacological
sertraline
5219
Intervention_Control
placebo
5220
Intervention_Pharmacological
sertraline
5221
Intervention_Control
placebo
5222
Intervention_Pharmacological
Sertraline
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Intervention_Pharmacological
sertraline-treated
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Intervention_Control
placebo-treated
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Intervention_Pharmacological
Sertraline
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Outcome_Mental
generalized social phobia :
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Outcome_Other
efficacy , safety , and tolerability of sertraline
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Outcome_Mental
generalized social phobia .
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Outcome_Other
efficacy assessments
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Outcome_Mental
Clinical Global Impression ( CGI ) improvement item and the mean changes from baseline to study endpoint in total score on the social phobia subscale of the Marks Fear Questionnaire and total score on the Brief Social Phobia Scale .
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Outcome_Mental
CGI improvement scores
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Outcome_Mental
social phobia subscale of the Marks Fear Questionnaire
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Outcome_Mental
total score on the Brief Social Phobia Scale
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Outcome_Other
efficacy measures .
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Outcome_Mental
generalized social phobia
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Participant_Condition
generalized social phobia :
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Participant_Age
Adult
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Participant_Condition
generalized social phobia
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Participant_Sample-size
N=204
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Participant_Sample-size
134
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Participant_Sample-size
69