OBJECTIVE: The aim of this open-label study was to assess the therapeutic benefits, response pattern, and safety of sertraline in children with social anxiety disorder. METHOD:Fourteen outpatient subjects with a primary Axis I diagnosis of social anxiety disorder were treated in an 8-week open trial of sertraline. Diagnostic and primary outcome measures included the Anxiety Disorders Interview Schedule for Children, Clinical Global Impressions scale (CGI), Social Phobia and Anxiety Inventory for Children, and a standardized behavioral avoidance test. RESULTS: As measured by the CGI (Improvement subscale), 36% (5/14) of subjects were classified as treatment responders and 29% (4/14) as partial responders by the end of the 8-week trial. A significant clinical response appeared by week 6. Self-report and behavioral measures showed significant clinical improvement into normal range across all domains measured. The mean dose of sertraline was 123.21+/-37.29 mg per day. Sertraline was generally well tolerated. CONCLUSION: In open treatment, sertraline resulted in significant improvement in symptoms of childhood social anxiety disorder. Absolute response rates varied depending on rating scales used. Findings from this study are sufficiently strong to warrant a future multisite, randomized, double-blind, placebo-controlled trial of sertraline for treatment of childhood social anxiety disorder.
RCT Entities:
OBJECTIVE: The aim of this open-label study was to assess the therapeutic benefits, response pattern, and safety of sertraline in children with social anxiety disorder. METHOD: Fourteen outpatient subjects with a primary Axis I diagnosis of social anxiety disorder were treated in an 8-week open trial of sertraline. Diagnostic and primary outcome measures included the Anxiety Disorders Interview Schedule for Children, Clinical Global Impressions scale (CGI), Social Phobia and Anxiety Inventory for Children, and a standardized behavioral avoidance test. RESULTS: As measured by the CGI (Improvement subscale), 36% (5/14) of subjects were classified as treatment responders and 29% (4/14) as partial responders by the end of the 8-week trial. A significant clinical response appeared by week 6. Self-report and behavioral measures showed significant clinical improvement into normal range across all domains measured. The mean dose of sertraline was 123.21+/-37.29 mg per day. Sertraline was generally well tolerated. CONCLUSION: In open treatment, sertraline resulted in significant improvement in symptoms of childhood social anxiety disorder. Absolute response rates varied depending on rating scales used. Findings from this study are sufficiently strong to warrant a future multisite, randomized, double-blind, placebo-controlled trial of sertraline for treatment of childhood social anxiety disorder.
Authors: Martin A Katzman; Pierre Bleau; Pierre Blier; Pratap Chokka; Kevin Kjernisted; Michael Van Ameringen; Martin M Antony; Stéphane Bouchard; Alain Brunet; Martine Flament; Sophie Grigoriadis; Sandra Mendlowitz; Kieron O'Connor; Kiran Rabheru; Peggy M A Richter; Melisa Robichaud; John R Walker Journal: BMC Psychiatry Date: 2014-07-02 Impact factor: 3.630
Authors: Scott N Compton; John T Walkup; Anne Marie Albano; John C Piacentini; Boris Birmaher; Joel T Sherrill; Golda S Ginsburg; Moira A Rynn; James T McCracken; Bruce D Waslick; Satish Iyengar; Phillip C Kendall; John S March Journal: Child Adolesc Psychiatry Ment Health Date: 2010-01-05 Impact factor: 3.033