Quetiapine for the treatment of bipolar II depression: Analysis of data from two randomized, double-blind, placebo-controlled studies
Abstract
Objective To investigate the efficacy and tolerability of quetiapine monotherapy for depressive episodes in patients with bipolar II disorder. Methods A post-hoc evaluation was conducted in 351 patients with bipolar II depression combined from two similarly designed double-blind, randomized, placebo-controlled, 8-week studies of quetiapine (300 or 600 mg/day) that included patients with bipolar I or II disorder (DSM-IV) exhibiting moderate to severe depression. The primary endpoint was change from baseline to week 8 in MADRS total score. Secondary endpoints included HAM-D, HAM-A, and CGI. Results In patients with bipolar II disorder, improvement in mean MADRS total score from baseline was significantly greater with quetiapine 300 (n = 107) and 600 mg/day (n = 106) from the first assessment (week 1) through week 8 compared with placebo (n = 108). The mean change from baseline at week 8 for quetiapine 300 and 600 mg/day versus placebo was -17.1 and -17.9 versus -13.3 (P = 0.005 and P = 0.001 versus placebo), respectively. Change in HAM-D, HAM-A, and CGI were also significantly greater for quetiapine groups versus placebo. Common adverse events in the quetiapine groups included dry mouth, sedation, and somnolence. Conclusion Quetiapine demonstrated significant efficacy as monotherapy, compared with placebo, for the treatment of acute depressive episodes in bipolar II disorder.
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Exploratory analysis performed in quetiapine trials exerts quite qualitative homogeneous results for this subpopulation.
“Nevertheless, exploratory analysis performed in quetiapine trials exerts quite qualitative homogeneous results for this subpopulation (Suppes et al. 2008).”
From Efficacy of modern antipsychotics in placebo-controlled trials in bipolar depression: a meta-analysis (2010) · cites this paper as Suppes et al. 2008
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Souery, D., Sabé, M., & Sentissi, O. (2023) · Elsevier eBooks · doi:10.1016/b978-2-294-77180-4.00008-1
Normal, Hypomanic, and Manic States: Key Differences and Their Implications
홍정완, & Kim, M.-D. (2026) · Springer eBooks · doi:10.1007/978-981-92-1323-8_5
- Authors
- Suppes, T., Hirschfeld, R. M., Vieta, E., Raines, S., & Paulsson, B.
- Affiliations
- The University of Texas Southwestern Medical Center (US)
- The University of Texas Medical Branch at Galveston (US)
- Universitat de Barcelona (ES)
- AstraZeneca (United Kingdom) (GB)
- AstraZeneca (Sweden) (SE)
- Corresponding author
- Suppes, Trisha
- Venue
- The World Journal of Biological Psychiatry
- Publisher
- Informa UK Limited
- Published
- 2008-01
- Volume
- 9
- Issue
- 3
- Pages
- 198-211
- ISSN
- 1562-2975 (ISSN-L)
- 1814-1412
- OpenAlex
- W2105761999
- Cited by
- 73
- References
- 33
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2023: 4 · 2022: 2 · 2021: 3 · 2020: 1 · 2019: 2 · 2017: 2 · 2016: 3 · 2014: 4 · 2013: 4 · 2012: 15
- FWCI
- 7.01
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The World Journal of Biological Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Funders
- AstraZeneca
- Stanley Medical Research Institute
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Keywords
- quetiapine, bipolar II disorder, bipolar depression, monotherapy, atypical antipsychotics, treatment efficacy, tolerability, adverse events, sedation, xerostomia, sleepiness
- MeSH terms
- Quetiapine Fumarate, Adult, Bipolar Disorder, Dibenzothiazepines, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Severity of Illness Index, Antipsychotic Agents, Treatment Outcome
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
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