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A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression.
Am J Psychiatry 2005; 162(7):1351-60AJ

Abstract

OBJECTIVE

There is a major unmet need for effective options in the treatment of bipolar depression.

METHOD

Five hundred forty-two outpatients with bipolar I (N=360) or II (N=182) disorder experiencing a major depressive episode (DSM-IV) were randomly assigned to 8 weeks of quetiapine (600 or 300 mg/day) or placebo. The primary efficacy measure was mean change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale total score. Additional efficacy assessments included the Hamilton Depression Rating Scale, Clinical Global Impression of severity and improvement, Hamilton Anxiety Rating Scale, Pittsburgh Sleep Quality Index, and Quality of Life Enjoyment and Satisfaction Questionnaire.

RESULTS

Quetiapine at either dose demonstrated statistically significant improvement in Montgomery-Asberg Depression Rating Scale total scores compared with placebo from week 1 onward. The proportions of patients meeting response criteria (> or =50% Montgomery-Asberg Depression Rating Scale score improvement) at the final assessment in the groups taking 600 and 300 mg/day of quetiapine were 58.2% and 57.6%, respectively, versus 36.1% for placebo. The proportions of patients meeting remission criteria (Montgomery-Asberg Depression Rating Scale < or =12) were 52.9% in the groups taking 600 and 300 mg/day of quetiapine versus 28.4% for placebo. Quetiapine at 600 and 300 mg/day significantly improved 9 of 10 and 8 of 10 Montgomery-Asberg Depression Rating Scale items, respectively, compared to placebo, including the core symptoms of depression. Treatment-emergent mania rates were low and similar for the quetiapine and placebo groups (3.2% and 3.9%, respectively).

CONCLUSIONS

Quetiapine monotherapy is efficacious and well tolerated for the treatment of bipolar depression.

Authors+Show Affiliations

University Hospitals of Cleveland and Case University School of Medicine, 11400 Euclid Ave., Suite 200, Cleveland, OH 44106, USA. joseph.calabrese@uhhs.comNo 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)

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

Language

eng

PubMed ID

15994719

Citation

Calabrese, Joseph R., et al. "A Randomized, Double-blind, Placebo-controlled Trial of Quetiapine in the Treatment of Bipolar I or II Depression." The American Journal of Psychiatry, vol. 162, no. 7, 2005, pp. 1351-60.
Calabrese JR, Keck PE, Macfadden W, et al. A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. Am J Psychiatry. 2005;162(7):1351-60.
Calabrese, J. R., Keck, P. E., Macfadden, W., Minkwitz, M., Ketter, T. A., Weisler, R. H., ... Mullen, J. (2005). A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. The American Journal of Psychiatry, 162(7), pp. 1351-60.
Calabrese JR, et al. A Randomized, Double-blind, Placebo-controlled Trial of Quetiapine in the Treatment of Bipolar I or II Depression. Am J Psychiatry. 2005;162(7):1351-60. PubMed PMID: 15994719.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. AU - Calabrese,Joseph R, AU - Keck,Paul E,Jr AU - Macfadden,Wayne, AU - Minkwitz,Margaret, AU - Ketter,Terence A, AU - Weisler,Richard H, AU - Cutler,Andrew J, AU - McCoy,Robin, AU - Wilson,Ellis, AU - Mullen,Jamie, PY - 2005/7/5/pubmed PY - 2005/8/18/medline PY - 2005/7/5/entrez SP - 1351 EP - 60 JF - The American journal of psychiatry JO - Am J Psychiatry VL - 162 IS - 7 N2 - OBJECTIVE: There is a major unmet need for effective options in the treatment of bipolar depression. METHOD: Five hundred forty-two outpatients with bipolar I (N=360) or II (N=182) disorder experiencing a major depressive episode (DSM-IV) were randomly assigned to 8 weeks of quetiapine (600 or 300 mg/day) or placebo. The primary efficacy measure was mean change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale total score. Additional efficacy assessments included the Hamilton Depression Rating Scale, Clinical Global Impression of severity and improvement, Hamilton Anxiety Rating Scale, Pittsburgh Sleep Quality Index, and Quality of Life Enjoyment and Satisfaction Questionnaire. RESULTS: Quetiapine at either dose demonstrated statistically significant improvement in Montgomery-Asberg Depression Rating Scale total scores compared with placebo from week 1 onward. The proportions of patients meeting response criteria (> or =50% Montgomery-Asberg Depression Rating Scale score improvement) at the final assessment in the groups taking 600 and 300 mg/day of quetiapine were 58.2% and 57.6%, respectively, versus 36.1% for placebo. The proportions of patients meeting remission criteria (Montgomery-Asberg Depression Rating Scale < or =12) were 52.9% in the groups taking 600 and 300 mg/day of quetiapine versus 28.4% for placebo. Quetiapine at 600 and 300 mg/day significantly improved 9 of 10 and 8 of 10 Montgomery-Asberg Depression Rating Scale items, respectively, compared to placebo, including the core symptoms of depression. Treatment-emergent mania rates were low and similar for the quetiapine and placebo groups (3.2% and 3.9%, respectively). CONCLUSIONS: Quetiapine monotherapy is efficacious and well tolerated for the treatment of bipolar depression. SN - 0002-953X UR - https://www.unboundmedicine.com/medline/citation/15994719/A_randomized_double_blind_placebo_controlled_trial_of_quetiapine_in_the_treatment_of_bipolar_I_or_II_depression_ L2 - https://ajp.psychiatryonline.org/doi/full/10.1176/appi.ajp.162.7.1351?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -