Extended-release quetiapine fumarate (quetiapine XR): a once-daily monotherapy effective in generalized anxiety disorder. Data from a randomized, double-blind, placebo- and active-controlled study
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The efficacy and tolerability of extended-release quetiapine fumarate (quetiapine XR) once-daily monotherapy in generalized anxiety disorder (GAD) was assessed. This multicentre, double-blind, randomized, placebo- and active-controlled, phase III trial consisted of a 1- to 4-wk enrolment/wash-out period and a 10-wk (8-wk active treatment, 2-wk post-treatment drug-discontinuation) study period; 873 patients were randomized to 50 mg or 150 mg quetiapine XR, 20 mg paroxetine, or placebo. Primary endpoint was change from randomization at week 8 in Hamilton Rating Scale for Anxiety (HAMA) total score. At week 8, all active agents produced significant improvements in HAMA total and psychic subscale scores vs. placebo; HAMA somatic subscale scores were significantly reduced only by 150 mg quetiapine XR. Significant separation from placebo (-2.90) in HAMA total score was observed at day 4 for 50 mg quetiapine XR (-4.43, p<0.001) and 150 mg quetiapine XR (-3.86, p<0.05), but not for paroxetine (-2.69). Remission (HAMA total score 7) rates at week 8 were significantly higher for 150 mg quetiapine XR (42.6%, p<0.01) and paroxetine (38.8%, p<0.05) vs. placebo (27.2%). The most common adverse events (AEs) were dry mouth, somnolence, fatigue, dizziness, and headache, for quetiapine XR, and nausea, headache, dizziness for paroxetine. A lower proportion of patients reported sexual dysfunction with quetiapine XR [0.9% (50 mg), 1.8% (150 mg)] than with placebo (2.3%) or paroxetine (7.4%). The incidence of AEs potentially related to extrapyramidal symptoms was: quetiapine XR: 50 mg, 6.8%, 150 mg, 5.0%; placebo, 1.8%; and paroxetine, 8.4%. Once-daily quetiapine XR is an effective and generally well-tolerated treatment for patients with GAD, with symptom improvement seen as early as day 4.
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The FDA reported that safety concerns for esketamine are misuse, abuse, dissociation, and sedation, for which a Risk Evaluation and Mitigation Strategy was planned.
“Additionally, the FDA reported that the safety concerns for esketamine are misuse, abuse, dissociation, and sedation, for which a Risk Evaluation and Mitigation Strategy was planned [143, 144].”
From Acute and Persistent Withdrawal Syndromes Following Discontinuation of Psychotropic Medications (2020) · cites this paper as [144]
The Safety and tolerability assessments and Discussion passages concern quetiapine XR in generalized anxiety disorder, not esketamine. Searches for esketamine, FDA safety concerns, and a Risk Evaluation and Mitigation Strategy found no passage addressing the attributed statement. The indexed passages provide no page numbers. (LLM, conf=0.78)
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- Authors
- Bandelow, B., Chouinard, G., Bobes, J., Ahokas, A., Eggens, I., Liu, S., & Eriksson, H.
- Affiliations
- University of Göttingen (DE)
- McGill University (CA)
- Universidad de Oviedo (ES)
- AstraZeneca (Sweden) (SE)
- AstraZeneca (United States) (US)
- Corresponding author
- Bandelow, Borwin
- Venue
- The International Journal of Neuropsychopharmacology
- Publisher
- Oxford University Press (OUP)
- Published
- 2009-08-20
- Volume
- 13
- Issue
- 03
- Pages
- 305
- ISSN
- 1461-1457 (ISSN-L)
- 1469-5111
- OpenAlex
- W2139280604
- Cited by
- 142
- References
- 49
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 9 · 2023: 3 · 2022: 2 · 2021: 3 · 2020: 7 · 2019: 2 · 2018: 2 · 2017: 11 · 2016: 6 · 2015: 11 · 2014: 15 · 2013: 16 · 2012: 12
- FWCI
- 20.28
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The International Journal of Neuropsychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- Consultation of the Doctoral Thesis Database (TESEO) (Ministerio de Educación, Cultura y Deporte) (submittedVersion, cc-by-nc-nd)
- GRO (submittedVersion)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Keywords
- generalized anxiety disorder, atypical antipsychotics, sustained-release formulation, monotherapy, paroxetine, Hamilton Anxiety Rating Scale, remission, sexual dysfunction, extrapyramidal symptoms, adverse events, drug tolerability, dose comparison, antidepressant efficacy, somatic anxiety, washout period
- MeSH terms
- Quetiapine Fumarate, Adolescent, Adult, Aged, Anxiety Disorders, Dibenzothiazepines, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Psychiatric Status Rating Scales, Antipsychotic Agents, Drug Delivery Systems, Treatment Outcome, Young Adult
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