A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Quetiapine or Lithium as Monotherapy for Mania in Bipolar Disorder
Abstract
Objective To evaluate the efficacy and tolerability of quetiapine monotherapy versus placebo for the treatment of mania associated with bipolar disorder. Method In an international, multicenter, double-blind, parallel-group, 12-week study, patients with a DSM-IV diagnosis of bipolar I disorder (manic episode) were randomly assigned to treatment with quetiapine (flexibly dosed up to 800 mg/day), placebo, or lithium. The primary efficacy measure was change from baseline in Young Mania Rating Scale (YMRS) score at day 21. Data were gathered from April 2001 to May 2002. Results More patients in the quetiapine (72/107) and lithium (67/98) groups completed the study compared with the placebo group (35/97). Improvement (reduction) in YMRS score was significantly greater for quetiapine than placebo at day 7 (-8.03 vs. -4.89; p Conclusions Quetiapine demonstrated superior efficacy to placebo in patients with bipolar mania and was well tolerated.
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Randomized controlled trials have demonstrated efficacy for second-generation antipsychotics in the treatment of acute mania in bipolar disorder.
“Randomized, controlled trials have demonstrated efficacy for second-generation antipsychotics in the treatment of acute mania in bipolar disorder.”
From Efficacy of modern antipsychotics in placebo-controlled trials in bipolar depression: a meta-analysis (2010) · cites this paper as Bowden et al. 2005
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- Authors
- Bowden, C. L., Grunze, H., Mullen, J., Brecher, M., Paulsson, B., Jones, M., Vågerö, M., & Svensson, K.
- Affiliations
- The University of Texas at San Antonio Health Science Center (US)
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2005-01-15
- Volume
- 66
- Issue
- 01
- Pages
- 111-121
- ISSN
- 0160-6689 (ISSN-L)
- OpenAlex
- W1966127736
- Cited by
- 376
- References
- 6
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 6 · 2023: 4 · 2022: 8 · 2021: 7 · 2020: 5 · 2019: 8 · 2018: 7 · 2017: 7 · 2016: 16 · 2015: 15 · 2014: 12 · 2013: 14 · 2012: 26
- FWCI
- 26.06
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Keywords
- quetiapine, lithium, bipolar mania, bipolar I disorder, monotherapy, atypical antipsychotics, Young Mania Rating Scale, treatment efficacy, tolerability, adverse events, extrapyramidal symptoms
- MeSH terms
- Quetiapine Fumarate, Adolescent, Adult, Aged, Basal Ganglia Diseases, Bipolar Disorder, Dibenzothiazepines, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, Hospitalization, Humans, Hyperprolactinemia, Lithium, Male, Middle Aged, Placebos, Psychiatric Status Rating Scales, Severity of Illness Index, Antipsychotic Agents, Treatment Outcome
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