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Effectiveness of the extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression.
J Affect Disord. 2010 Feb; 121(1-2):106-15.JA

Abstract

BACKGROUND

To evaluate the effectiveness of quetiapine extended release once daily in bipolar depression.

METHODS

Double-blind, placebo-controlled study in acutely depressed adults with bipolar I or II disorder, with or without rapid cycling. Patients were randomized to 8 weeks of quetiapine extended release (XR) 300 mg daily monotherapy or placebo. The primary outcome measure was change from baseline to Week 8 in MADRS total score.

RESULTS

Quetiapine XR 300 mg once daily (N=133) showed significantly greater improvement in depressive symptoms compared with placebo (N=137) from Week 1 (p<0.001) through to Week 8 (p<0.001). Mean change in MADRS total score at Week 8 was -17.4 in the quetiapine XR group and -11.9 in the placebo group (p<0.001). Response (>or=50 reduction in MADRS total score) and remission (MADRS total score<or=12) rates at Week 8 were significantly higher with quetiapine XR (p<0.001) compared with placebo (p<0.05). Quetiapine XR improved core symptoms of depression. The most common adverse events associated with quetiapine XR were dry mouth, somnolence, and sedation. Greater weight gain was observed in patients on quetiapine XR relative to placebo.

LIMITATIONS

Fewer patients with bipolar II disorder included, only one fixed dose tested and the lack of an active comparator.

CONCLUSIONS

Quetiapine XR (300 mg) once daily monotherapy was significantly more effective than placebo for treating episodes of depression in bipolar I disorder, throughout the 8-week study, with significance observed as early as Day 7. Adverse events were consistent with the known effects of quetiapine.

Authors+Show Affiliations

Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, VA Palo Alto Health Care System, Palo Alto, CA, USA. tsuppes@stanford.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19903574

Citation

Suppes, Trisha, et al. "Effectiveness of the Extended Release Formulation of Quetiapine as Monotherapy for the Treatment of Acute Bipolar Depression." Journal of Affective Disorders, vol. 121, no. 1-2, 2010, pp. 106-15.
Suppes T, Datto C, Minkwitz M, et al. Effectiveness of the extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression. J Affect Disord. 2010;121(1-2):106-15.
Suppes, T., Datto, C., Minkwitz, M., Nordenhem, A., Walker, C., & Darko, D. (2010). Effectiveness of the extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression. Journal of Affective Disorders, 121(1-2), 106-15. https://doi.org/10.1016/j.jad.2009.10.007
Suppes T, et al. Effectiveness of the Extended Release Formulation of Quetiapine as Monotherapy for the Treatment of Acute Bipolar Depression. J Affect Disord. 2010;121(1-2):106-15. PubMed PMID: 19903574.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effectiveness of the extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression. AU - Suppes,Trisha, AU - Datto,Catherine, AU - Minkwitz,Margaret, AU - Nordenhem,Arvid, AU - Walker,Chris, AU - Darko,Denis, Y1 - 2009/11/08/ PY - 2009/05/05/received PY - 2009/10/01/revised PY - 2009/10/12/accepted PY - 2009/11/12/entrez PY - 2009/11/12/pubmed PY - 2010/4/15/medline SP - 106 EP - 15 JF - Journal of affective disorders JO - J Affect Disord VL - 121 IS - 1-2 N2 - BACKGROUND: To evaluate the effectiveness of quetiapine extended release once daily in bipolar depression. METHODS: Double-blind, placebo-controlled study in acutely depressed adults with bipolar I or II disorder, with or without rapid cycling. Patients were randomized to 8 weeks of quetiapine extended release (XR) 300 mg daily monotherapy or placebo. The primary outcome measure was change from baseline to Week 8 in MADRS total score. RESULTS: Quetiapine XR 300 mg once daily (N=133) showed significantly greater improvement in depressive symptoms compared with placebo (N=137) from Week 1 (p<0.001) through to Week 8 (p<0.001). Mean change in MADRS total score at Week 8 was -17.4 in the quetiapine XR group and -11.9 in the placebo group (p<0.001). Response (>or=50 reduction in MADRS total score) and remission (MADRS total score<or=12) rates at Week 8 were significantly higher with quetiapine XR (p<0.001) compared with placebo (p<0.05). Quetiapine XR improved core symptoms of depression. The most common adverse events associated with quetiapine XR were dry mouth, somnolence, and sedation. Greater weight gain was observed in patients on quetiapine XR relative to placebo. LIMITATIONS: Fewer patients with bipolar II disorder included, only one fixed dose tested and the lack of an active comparator. CONCLUSIONS: Quetiapine XR (300 mg) once daily monotherapy was significantly more effective than placebo for treating episodes of depression in bipolar I disorder, throughout the 8-week study, with significance observed as early as Day 7. Adverse events were consistent with the known effects of quetiapine. SN - 1573-2517 UR - https://www.unboundmedicine.com/medline/citation/19903574/Effectiveness_of_the_extended_release_formulation_of_quetiapine_as_monotherapy_for_the_treatment_of_acute_bipolar_depression_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0165-0327(09)00467-4 DB - PRIME DP - Unbound Medicine ER -