OBJECTIVE: Prospectively planned pooled analysis evaluating efficacy and tolerability of acute quetiapine XR monotherapy in generalised anxiety disorder. METHODS: Data from three 10-week, randomised, double-blind, placebo-controlled studies of similar design were analysed. RESULTS: At Week 8, Hamilton Anxiety Rating Scale (HAM-A) total score significantly improved with quetiapine XR: least squares means change -13.31, p < 0.001 (50 mg/day, n = 452), -14.39, p < 0.001 (150 mg/day, n = 673) and -12.50, p < 0.05 (300 mg/day, n = 444) versus -11.30 placebo; significant (p < 0.001, n = 665) improvements versus placebo were observed with each dose at Week 1. Significant improvements versus placebo at Week 8 are as follows: HAM-A psychic symptom subscale, Montgomery-Åsberg Depression Rating Scale total, Pittsburgh Sleep Quality Index global scores for all quetiapineXR doses; HAM-A response and remission rates, HAM-A somatic symptom subscale score, Clinical Global Impression-Severity of Illness total score, % patients with Clinical Global Impression-Improvement score ≤2 with quetiapine XR 50 and 150 mg/day; and Quality of Life Enjoyment and Satisfaction Questionnaire short form % maximum total score with quetiapine XR 150 mg/day. In the quetiapine XR 50, 150 and 300 mg/day and placebo groups, 13.2%, 16.5%, 24.0% and 5.4% of patients discontinued because of an adverse event, and 1.9%, 1.4%, 3.7% and 1.8% of patients experienced clinically significant changes in glucose. The most common adverse events with quetiapine XR included dry mouth, somnolence, sedation and constipation. CONCLUSION:Quetiapine XR monotherapy reduced the symptoms of generalised anxiety disorder, with improvement from Week 1. Adverse events were consistent with the known tolerability profile of quetiapine.
RCT Entities:
OBJECTIVE: Prospectively planned pooled analysis evaluating efficacy and tolerability of acute quetiapine XR monotherapy in generalised anxiety disorder. METHODS: Data from three 10-week, randomised, double-blind, placebo-controlled studies of similar design were analysed. RESULTS: At Week 8, Hamilton Anxiety Rating Scale (HAM-A) total score significantly improved with quetiapine XR: least squares means change -13.31, p < 0.001 (50 mg/day, n = 452), -14.39, p < 0.001 (150 mg/day, n = 673) and -12.50, p < 0.05 (300 mg/day, n = 444) versus -11.30 placebo; significant (p < 0.001, n = 665) improvements versus placebo were observed with each dose at Week 1. Significant improvements versus placebo at Week 8 are as follows: HAM-A psychic symptom subscale, Montgomery-Åsberg Depression Rating Scale total, Pittsburgh Sleep Quality Index global scores for all quetiapine XR doses; HAM-A response and remission rates, HAM-A somatic symptom subscale score, Clinical Global Impression-Severity of Illness total score, % patients with Clinical Global Impression-Improvement score ≤2 with quetiapine XR 50 and 150 mg/day; and Quality of Life Enjoyment and Satisfaction Questionnaire short form % maximum total score with quetiapine XR 150 mg/day. In the quetiapine XR 50, 150 and 300 mg/day and placebo groups, 13.2%, 16.5%, 24.0% and 5.4% of patients discontinued because of an adverse event, and 1.9%, 1.4%, 3.7% and 1.8% of patients experienced clinically significant changes in glucose. The most common adverse events with quetiapine XR included dry mouth, somnolence, sedation and constipation. CONCLUSION:Quetiapine XR monotherapy reduced the symptoms of generalised anxiety disorder, with improvement from Week 1. Adverse events were consistent with the known tolerability profile of quetiapine.
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: Márcio G Soeiro-DE-Souza; Vasco Videira Dias; Giovanni Missio; Vicent Balanzá-Martinez; Leandro Valiengo; André F Carvalho; Ricardo Alberto Moreno Journal: Exp Ther Med Date: 2015-01-23 Impact factor: 2.447