OBJECTIVE: To investigate the efficacy and tolerability of quetiapine monotherapy for depressive episodes in patients with bipolar II disorder. METHODS: A post-hoc evaluation was conducted in 351 patients with bipolar II depression combined from two similarly designed double-blind, randomized, placebo-controlled, 8-week studies of quetiapine (300 or 600 mg/day) that included patients with bipolar I or II disorder (DSM-IV) exhibiting moderate to severe depression. The primary endpoint was change from baseline to week 8 in MADRS total score. Secondary endpoints included HAM-D, HAM-A, and CGI. RESULTS: In patients with bipolar II disorder, improvement in mean MADRS total score from baseline was significantly greater with quetiapine300 (n = 107) and 600 mg/day (n = 106) from the first assessment (week 1) through week 8 compared with placebo (n = 108). The mean change from baseline at week 8 for quetiapine300 and 600 mg/day versus placebo was -17.1 and -17.9 versus -13.3 (P = 0.005 and P = 0.001 versus placebo), respectively. Change in HAM-D, HAM-A, and CGI were also significantly greater for quetiapine groups versus placebo. Common adverse events in the quetiapine groups included dry mouth, sedation, and somnolence. CONCLUSION:Quetiapine demonstrated significant efficacy as monotherapy, compared with placebo, for the treatment of acute depressive episodes in bipolar II disorder.
RCT Entities:
OBJECTIVE: To investigate the efficacy and tolerability of quetiapine monotherapy for depressive episodes in patients with bipolar II disorder. METHODS: A post-hoc evaluation was conducted in 351 patients with bipolar II depression combined from two similarly designed double-blind, randomized, placebo-controlled, 8-week studies of quetiapine (300 or 600 mg/day) that included patients with bipolar I or II disorder (DSM-IV) exhibiting moderate to severe depression. The primary endpoint was change from baseline to week 8 in MADRS total score. Secondary endpoints included HAM-D, HAM-A, and CGI. RESULTS: In patients with bipolar II disorder, improvement in mean MADRS total score from baseline was significantly greater with quetiapine 300 (n = 107) and 600 mg/day (n = 106) from the first assessment (week 1) through week 8 compared with placebo (n = 108). The mean change from baseline at week 8 for quetiapine 300 and 600 mg/day versus placebo was -17.1 and -17.9 versus -13.3 (P = 0.005 and P = 0.001 versus placebo), respectively. Change in HAM-D, HAM-A, and CGI were also significantly greater for quetiapine groups versus placebo. Common adverse events in the quetiapine groups included dry mouth, sedation, and somnolence. CONCLUSION:Quetiapine demonstrated significant efficacy as monotherapy, compared with placebo, for the treatment of acute depressive episodes in bipolar II disorder.
Authors: Konstantinos N Fountoulakis; Lakshmi Yatham; Heinz Grunze; Eduard Vieta; Allan Young; Pierre Blier; Siegfried Kasper; Hans Jurgen Moeller Journal: Int J Neuropsychopharmacol Date: 2017-02-01 Impact factor: 5.176
Authors: Roger S McIntyre; Martin Alda; Ross J Baldessarini; Michael Bauer; Michael Berk; Christoph U Correll; Andrea Fagiolini; Kostas Fountoulakis; Mark A Frye; Heinz Grunze; Lars V Kessing; David J Miklowitz; Gordon Parker; Robert M Post; Alan C Swann; Trisha Suppes; Eduard Vieta; Allan Young; Mario Maj Journal: World Psychiatry Date: 2022-10 Impact factor: 79.683
Authors: Trisha Suppes; Lauren B Marangell; Ira H Bernstein; Dorothy I Kelly; E Grace Fischer; Holly A Zboyan; Diane E Snow; Melissa Martinez; Rayan Al Jurdi; Geetha Shivakumar; Suresh Sureddi; Robert Gonzalez Journal: J Affect Disord Date: 2008-03-20 Impact factor: 4.839
Authors: Amber Edinoff; Miriam T Ruoff; Yahya T Ghaffar; Arthur Rezayev; Devanshi Jani; Adam M Kaye; Elyse M Cornett; Alan D Kaye; Omar Viswanath; Ivan Urits Journal: Psychopharmacol Bull Date: 2020-09-14