OBJECTIVE: The aim of this study was to evaluate the safety and efficacy of sertraline in children and adolescents who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for posttraumatic stress disorder (PTSD). METHOD: Children and adolescents (6-17 years old) meeting DSM-IV criteria for PTSD were randomized to 10 weeks of double-blind treatment with sertraline (50-200 mg/day) or placebo. The primary efficacy measure was the University of California, Los Angeles Post-Traumatic Stress Disorder Index for DSM-IV (UCLA PTSD-I). RESULTS: A total of 131 patients met entry criteria and were randomized to sertraline (n = 67; female, 59.7%; mean age, 10.8; mean UCLA PTSD-I score, 43.8 ± 8.5) or placebo (n = 62; female, 61.3%; mean age, 11.2; mean UCLA PTSD-I score, 42.1 ± 8.8). There was no difference between sertraline and placebo in least squares (LS) mean change in the UCLA PTSD-I score, either on a completer analysis (-20.4 ± 2.1 vs. -22.8 ± 2.1; p = 0.373) or on an last observation carried forward (LOCF) end point analysis (-17.7 ± 1.9 vs. -20.8 ± 2.1; p = 0.201). Attrition was higher on sertraline (29.9%) compared to placebo (17.7%). Discontinuation due to adverse events occurred in a 7.5% treated with sertraline and 3.2% treated with placebo. CONCLUSIONS: Sertraline was a generally safe treatment in children and adolescents with PTSD, but did not demonstrate efficacy when compared to placebo during 10 weeks of treatment. ClinicalTrials.gov Identifier: NCT00150306.
RCT Entities:
OBJECTIVE: The aim of this study was to evaluate the safety and efficacy of sertraline in children and adolescents who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for posttraumatic stress disorder (PTSD). METHOD:Children and adolescents (6-17 years old) meeting DSM-IV criteria for PTSD were randomized to 10 weeks of double-blind treatment with sertraline (50-200 mg/day) or placebo. The primary efficacy measure was the University of California, Los Angeles Post-Traumatic Stress Disorder Index for DSM-IV (UCLA PTSD-I). RESULTS: A total of 131 patients met entry criteria and were randomized to sertraline (n = 67; female, 59.7%; mean age, 10.8; mean UCLA PTSD-I score, 43.8 ± 8.5) or placebo (n = 62; female, 61.3%; mean age, 11.2; mean UCLA PTSD-I score, 42.1 ± 8.8). There was no difference between sertraline and placebo in least squares (LS) mean change in the UCLA PTSD-I score, either on a completer analysis (-20.4 ± 2.1 vs. -22.8 ± 2.1; p = 0.373) or on an last observation carried forward (LOCF) end point analysis (-17.7 ± 1.9 vs. -20.8 ± 2.1; p = 0.201). Attrition was higher on sertraline (29.9%) compared to placebo (17.7%). Discontinuation due to adverse events occurred in a 7.5% treated with sertraline and 3.2% treated with placebo. CONCLUSIONS:Sertraline was a generally safe treatment in children and adolescents with PTSD, but did not demonstrate efficacy when compared to placebo during 10 weeks of treatment. ClinicalTrials.gov Identifier: NCT00150306.
Authors: Chad E Shenk; Brooks Keeshin; Heather E Bensman; Anneke E Olson; Brian Allen Journal: Pharmacol Biochem Behav Date: 2021-11-10 Impact factor: 3.533
Authors: Cosima Locher; Helen Koechlin; Sean R Zion; Christoph Werner; Daniel S Pine; Irving Kirsch; Ronald C Kessler; Joe Kossowsky Journal: JAMA Psychiatry Date: 2017-10-01 Impact factor: 21.596
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: Marco Solmi; Michele Fornaro; Edoardo G Ostinelli; Caroline Zangani; Giovanni Croatto; Francesco Monaco; Damir Krinitski; Paolo Fusar-Poli; Christoph U Correll Journal: World Psychiatry Date: 2020-06 Impact factor: 49.548