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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

Relationship between MADRS total score at baseline and of treatment (ITT).
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Fig4: Relationship between MADRS total score at baseline and of treatment (ITT).

Mentions: Patients with bipolar II disorder stratified by a rapid- (≥4 mood episodes per year) or nonrapid-cycling course also demonstrated significant improvements in MADRS total score at week 8. Among patients without a rapid-cycling course, MADRS total score improved significantly by a mean (SE) of 15.18 (0.67) and 14.25 (0.66) with quetiapine 300 and 600 mg/day compared with 11.58 (0.75) points for placebo (p < 0.001 and p = 0.005 for quetiapine 300 and 600 mg/day, respectively) at week 8. Significant symptomatic improvements at week 8 were also observed in patients with rapid cycling: 16.80 (1.63) and 16.92 (1.71) for quetiapine 300 and 600 mg/day versus 11.12 (1.95) for placebo (p = 0.011 and p = 0.012, respectively). In the exploratory analysis of the relationship between MADRS total score at baseline and end of treatment, there was an indication that the difference between placebo and both quetiapine doses at end of treatment increased as baseline score increased (Table 2; Figure 4). However, given the post hoc and exploratory nature of this analysis where the studies were not designed for this purpose, no formal inference can be made.Table 2


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)

Relationship between MADRS total score at baseline and of treatment (ITT).
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Fig4: Relationship between MADRS total score at baseline and of treatment (ITT).
Mentions: Patients with bipolar II disorder stratified by a rapid- (≥4 mood episodes per year) or nonrapid-cycling course also demonstrated significant improvements in MADRS total score at week 8. Among patients without a rapid-cycling course, MADRS total score improved significantly by a mean (SE) of 15.18 (0.67) and 14.25 (0.66) with quetiapine 300 and 600 mg/day compared with 11.58 (0.75) points for placebo (p < 0.001 and p = 0.005 for quetiapine 300 and 600 mg/day, respectively) at week 8. Significant symptomatic improvements at week 8 were also observed in patients with rapid cycling: 16.80 (1.63) and 16.92 (1.71) for quetiapine 300 and 600 mg/day versus 11.12 (1.95) for placebo (p = 0.011 and p = 0.012, respectively). In the exploratory analysis of the relationship between MADRS total score at baseline and end of treatment, there was an indication that the difference between placebo and both quetiapine doses at end of treatment increased as baseline score increased (Table 2; Figure 4). However, given the post hoc and exploratory nature of this analysis where the studies were not designed for this purpose, no formal inference can be made.Table 2

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