Quetiapine for the treatment of bipolar II depression: Analysis of data from two randomized, double-blind, placebo-controlled studies

Trisha Suppes, Robert M. Hirschfeld, Eduard Vieta, Shane Raines, Bjorn Paulsson

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

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 600mg/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 600mg/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 600mg/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.

Original languageEnglish (US)
Pages (from-to)198-211
Number of pages14
JournalWorld Journal of Biological Psychiatry
Volume9
Issue number3
DOIs
StatePublished - 2008

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Bipolar Disorder
Placebos
Therapeutics
Quetiapine Fumarate
Diagnostic and Statistical Manual of Mental Disorders
Mouth
Depression

Keywords

  • Bipolar II disorder
  • Depression
  • Monotherapy
  • Quetiapine

ASJC Scopus subject areas

  • Biological Psychiatry
  • Psychiatry and Mental health

Cite this

Quetiapine for the treatment of bipolar II depression : Analysis of data from two randomized, double-blind, placebo-controlled studies. / Suppes, Trisha; Hirschfeld, Robert M.; Vieta, Eduard; Raines, Shane; Paulsson, Bjorn.

In: World Journal of Biological Psychiatry, Vol. 9, No. 3, 2008, p. 198-211.

Research output: Contribution to journalArticle

Suppes, Trisha ; Hirschfeld, Robert M. ; Vieta, Eduard ; Raines, Shane ; Paulsson, Bjorn. / Quetiapine for the treatment of bipolar II depression : Analysis of data from two randomized, double-blind, placebo-controlled studies. In: World Journal of Biological Psychiatry. 2008 ; Vol. 9, No. 3. pp. 198-211.
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