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A double-blind, placebo-controlled study of quetiapine and paroxetine as monotherapy in adults with bipolar depression (EMBOLDEN II).
J Clin Psychiatry. 2010 Feb; 71(2):163-74.JC

Abstract

OBJECTIVE

The aim of this study was to evaluate the efficacy and tolerability of quetiapine and paroxetine monotherapy for major depression in bipolar disorder.

METHOD

740 patients (478 bipolar I, 262 bipolar II) with major depressive episodes (DSM-IV) were randomly assigned to quetiapine 300 mg/d (n = 245), quetiapine 600 mg/d (n = 247), paroxetine 20 mg/d (n = 122), or placebo (n = 126) for 8 weeks. The primary end point was the change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score. The study was conducted from May 2005 to May 2007.

RESULTS

Mean MADRS score change from baseline at 8 weeks was -16.19 for quetiapine 300 mg, -16.31 for quetiapine 600 mg, -13.76 for paroxetine, and -12.60 for placebo (P < .001 for both quetiapine doses, P = .313 for paroxetine, vs placebo). Quetiapine-treated (both doses), but not paroxetine-treated, patients showed significantly greater improvements (P < or = .05) in most secondary outcomes measures at week 8 versus the placebo group. Paroxetine significantly improved Hamilton Anxiety Rating Scale scores versus placebo (P < .05) but not MADRS or Hamilton Depression Rating Scale (HDRS) scores. Both quetiapine doses were associated with greater improvements than paroxetine for MADRS and HDRS scores. The most common adverse events were dry mouth, somnolence, sedation, and dizziness with quetiapine (both doses) and dry mouth, sedation, headache, insomnia, and nausea with paroxetine. The incidence of treatment-emergent mania/hypomania was lower with quetiapine compared with paroxetine and placebo.

CONCLUSIONS

Quetiapine (300 or 600 mg/d), but not paroxetine, was more effective than placebo for treating acute depressive episodes in bipolar I and II disorder. Quetiapine treatment was generally well tolerated.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00119652.

Authors+Show Affiliations

Lindner Center of HOPE Research Institute, Mason, OH 45040, USA. Susan.Mcelroy@lindnercenter.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20122366

Citation

McElroy, Susan L., et al. "A Double-blind, Placebo-controlled Study of Quetiapine and Paroxetine as Monotherapy in Adults With Bipolar Depression (EMBOLDEN II)." The Journal of Clinical Psychiatry, vol. 71, no. 2, 2010, pp. 163-74.
McElroy SL, Weisler RH, Chang W, et al. A double-blind, placebo-controlled study of quetiapine and paroxetine as monotherapy in adults with bipolar depression (EMBOLDEN II). J Clin Psychiatry. 2010;71(2):163-74.
McElroy, S. L., Weisler, R. H., Chang, W., Olausson, B., Paulsson, B., Brecher, M., Agambaram, V., Merideth, C., Nordenhem, A., & Young, A. H. (2010). A double-blind, placebo-controlled study of quetiapine and paroxetine as monotherapy in adults with bipolar depression (EMBOLDEN II). The Journal of Clinical Psychiatry, 71(2), 163-74. https://doi.org/10.4088/JCP.08m04942gre
McElroy SL, et al. A Double-blind, Placebo-controlled Study of Quetiapine and Paroxetine as Monotherapy in Adults With Bipolar Depression (EMBOLDEN II). J Clin Psychiatry. 2010;71(2):163-74. PubMed PMID: 20122366.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind, placebo-controlled study of quetiapine and paroxetine as monotherapy in adults with bipolar depression (EMBOLDEN II). AU - McElroy,Susan L, AU - Weisler,Richard H, AU - Chang,William, AU - Olausson,Bengt, AU - Paulsson,Björn, AU - Brecher,Martin, AU - Agambaram,Vasavan, AU - Merideth,Charles, AU - Nordenhem,Arvid, AU - Young,Allan H, AU - ,, Y1 - 2010/01/26/ PY - 2008/12/10/received PY - 2009/12/14/accepted PY - 2010/2/4/entrez PY - 2010/2/4/pubmed PY - 2010/4/23/medline SP - 163 EP - 74 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 71 IS - 2 N2 - OBJECTIVE: The aim of this study was to evaluate the efficacy and tolerability of quetiapine and paroxetine monotherapy for major depression in bipolar disorder. METHOD: 740 patients (478 bipolar I, 262 bipolar II) with major depressive episodes (DSM-IV) were randomly assigned to quetiapine 300 mg/d (n = 245), quetiapine 600 mg/d (n = 247), paroxetine 20 mg/d (n = 122), or placebo (n = 126) for 8 weeks. The primary end point was the change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score. The study was conducted from May 2005 to May 2007. RESULTS: Mean MADRS score change from baseline at 8 weeks was -16.19 for quetiapine 300 mg, -16.31 for quetiapine 600 mg, -13.76 for paroxetine, and -12.60 for placebo (P < .001 for both quetiapine doses, P = .313 for paroxetine, vs placebo). Quetiapine-treated (both doses), but not paroxetine-treated, patients showed significantly greater improvements (P < or = .05) in most secondary outcomes measures at week 8 versus the placebo group. Paroxetine significantly improved Hamilton Anxiety Rating Scale scores versus placebo (P < .05) but not MADRS or Hamilton Depression Rating Scale (HDRS) scores. Both quetiapine doses were associated with greater improvements than paroxetine for MADRS and HDRS scores. The most common adverse events were dry mouth, somnolence, sedation, and dizziness with quetiapine (both doses) and dry mouth, sedation, headache, insomnia, and nausea with paroxetine. The incidence of treatment-emergent mania/hypomania was lower with quetiapine compared with paroxetine and placebo. CONCLUSIONS: Quetiapine (300 or 600 mg/d), but not paroxetine, was more effective than placebo for treating acute depressive episodes in bipolar I and II disorder. Quetiapine treatment was generally well tolerated. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00119652. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/20122366/A_double_blind_placebo_controlled_study_of_quetiapine_and_paroxetine_as_monotherapy_in_adults_with_bipolar_depression__EMBOLDEN_II__ L2 - http://www.psychiatrist.com/jcp/article/pages/2010/v71n02/v71n0207.aspx DB - PRIME DP - Unbound Medicine ER -