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Quetiapine monotherapy in bipolar II depression: combined data from four large, randomized studies.

Young AH, Calabrese JR, Gustafsson U, Berk M, McElroy SL, Thase ME, Suppes T, Earley W - Int J Bipolar Disord (2013)

Bottom Line: Improvements in mean MADRS total scores from baseline to week 8 were significantly greater with quetiapine 300 and 600 mg/day (-15.58 [n = 283] and -14.88 [n = 289]; p < 0.001) compared with placebo (-11.61 [n = 204]).Common adverse events associated with quetiapine (both doses) included dry mouth, somnolence, sedation, dizziness, and headache.Quetiapine monotherapy demonstrated significant efficacy compared with placebo and was generally well tolerated in the treatment of bipolar II depression.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry, Imperial College, London, SW7 2AZ UK ; Centre for Affective Disorders, Institute of Psychiatry, King's College, London, WC2R 2LS UK.

ABSTRACT

Background: Despite being present in up to 1% of the population, few controlled trials have examined the efficacy of treatments for bipolar II depression. Pooled data are presented from four placebo-controlled studies (BOLDER I [5077US/0049] and II [D1447C00135]; EMBOLDEN I [D1447C00001] and II [D1447C00134]) that evaluated the efficacy of quetiapine monotherapy for depressive episodes in patients with bipolar II disorder.

Methods: All studies included an 8-week, double-blind treatment phase in which patients were randomly assigned to treatment with quetiapine 300 mg/day, quetiapine 600 mg/day, or placebo. Outcome measures included the change from baseline in MADRS total score at week 8, effect sizes, and MADRS response and remission rates.

Results and discussion: Improvements in mean MADRS total scores from baseline to week 8 were significantly greater with quetiapine 300 and 600 mg/day (-15.58 [n = 283] and -14.88 [n = 289]; p < 0.001) compared with placebo (-11.61 [n = 204]). The MADRS effect sizes were 0.44 for quetiapine 300 mg/day and 0.47 for 600 mg/day (p < 0.001 vs placebo). Significantly higher proportions of patients receiving quetiapine, at both doses, than placebo-treated patients achieved response and remission at week 8 (p < 0.01). Common adverse events associated with quetiapine (both doses) included dry mouth, somnolence, sedation, dizziness, and headache. Rates of mania and hypomania were similar for quetiapine and placebo. Quetiapine monotherapy demonstrated significant efficacy compared with placebo and was generally well tolerated in the treatment of bipolar II depression.

No MeSH data available.


Related in: MedlinePlus

Patient disposition.
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Fig1: Patient disposition.

Mentions: Patient disposition is shown in Figure 1. A total of 776 (35.2%) patients with bipolar II depression were included in the ITT population (283, 289, and 204 patients received quetiapine 300 mg/day, quetiapine 600 mg/day, or placebo, respectively). The safety population comprised 819 patients with bipolar II depression (298, 307, and 214 patients received quetiapine 300 mg/day, quetiapine 600 mg/day, or placebo, respectively), representing 35.4% of the total pooled safety population of patients with bipolar I or II depression from the four studies (N = 2,314).Figure 1


Quetiapine monotherapy in bipolar II depression: combined data from four large, randomized studies.

Young AH, Calabrese JR, Gustafsson U, Berk M, McElroy SL, Thase ME, Suppes T, Earley W - Int J Bipolar Disord (2013)

Patient disposition.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4230312&req=5

Fig1: Patient disposition.
Mentions: Patient disposition is shown in Figure 1. A total of 776 (35.2%) patients with bipolar II depression were included in the ITT population (283, 289, and 204 patients received quetiapine 300 mg/day, quetiapine 600 mg/day, or placebo, respectively). The safety population comprised 819 patients with bipolar II depression (298, 307, and 214 patients received quetiapine 300 mg/day, quetiapine 600 mg/day, or placebo, respectively), representing 35.4% of the total pooled safety population of patients with bipolar I or II depression from the four studies (N = 2,314).Figure 1

Bottom Line: Improvements in mean MADRS total scores from baseline to week 8 were significantly greater with quetiapine 300 and 600 mg/day (-15.58 [n = 283] and -14.88 [n = 289]; p < 0.001) compared with placebo (-11.61 [n = 204]).Common adverse events associated with quetiapine (both doses) included dry mouth, somnolence, sedation, dizziness, and headache.Quetiapine monotherapy demonstrated significant efficacy compared with placebo and was generally well tolerated in the treatment of bipolar II depression.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry, Imperial College, London, SW7 2AZ UK ; Centre for Affective Disorders, Institute of Psychiatry, King's College, London, WC2R 2LS UK.

ABSTRACT

Background: Despite being present in up to 1% of the population, few controlled trials have examined the efficacy of treatments for bipolar II depression. Pooled data are presented from four placebo-controlled studies (BOLDER I [5077US/0049] and II [D1447C00135]; EMBOLDEN I [D1447C00001] and II [D1447C00134]) that evaluated the efficacy of quetiapine monotherapy for depressive episodes in patients with bipolar II disorder.

Methods: All studies included an 8-week, double-blind treatment phase in which patients were randomly assigned to treatment with quetiapine 300 mg/day, quetiapine 600 mg/day, or placebo. Outcome measures included the change from baseline in MADRS total score at week 8, effect sizes, and MADRS response and remission rates.

Results and discussion: Improvements in mean MADRS total scores from baseline to week 8 were significantly greater with quetiapine 300 and 600 mg/day (-15.58 [n = 283] and -14.88 [n = 289]; p < 0.001) compared with placebo (-11.61 [n = 204]). The MADRS effect sizes were 0.44 for quetiapine 300 mg/day and 0.47 for 600 mg/day (p < 0.001 vs placebo). Significantly higher proportions of patients receiving quetiapine, at both doses, than placebo-treated patients achieved response and remission at week 8 (p < 0.01). Common adverse events associated with quetiapine (both doses) included dry mouth, somnolence, sedation, dizziness, and headache. Rates of mania and hypomania were similar for quetiapine and placebo. Quetiapine monotherapy demonstrated significant efficacy compared with placebo and was generally well tolerated in the treatment of bipolar II depression.

No MeSH data available.


Related in: MedlinePlus