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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

Difference in mean change from baseline in MADRS individual item scores at week 8 (ITT population; LOCF).
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Fig5: Difference in mean change from baseline in MADRS individual item scores at week 8 (ITT population; LOCF).

Mentions: Following 8 weeks of treatment, quetiapine at doses of 300 and 600 mg/day was associated with significant improvements in the majority of the individual MADRS items when compared with placebo (p < 0.05 vs placebo, Figure 5), with the exceptions of apparent sadness for quetiapine 300 mg/day, and concentration difficulties and lassitude for 600 mg/day. From week 4 onward, there were significantly greater improvements in MADRS Item 10 (suicidal thoughts) scores with both doses of quetiapine (p < 0.05 vs placebo).Figure 5


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)

Difference in mean change from baseline in MADRS individual item scores at week 8 (ITT population; LOCF).
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Fig5: Difference in mean change from baseline in MADRS individual item scores at week 8 (ITT population; LOCF).
Mentions: Following 8 weeks of treatment, quetiapine at doses of 300 and 600 mg/day was associated with significant improvements in the majority of the individual MADRS items when compared with placebo (p < 0.05 vs placebo, Figure 5), with the exceptions of apparent sadness for quetiapine 300 mg/day, and concentration difficulties and lassitude for 600 mg/day. From week 4 onward, there were significantly greater improvements in MADRS Item 10 (suicidal thoughts) scores with both doses of quetiapine (p < 0.05 vs placebo).Figure 5

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