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  • The International Journal of Neuropsychopharmacology, Volume 13, Issue 3
  • April 2010, pp. 305-320

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

  • Borwin Bandelow (a1), Guy Chouinard (a2), Julio Bobes (a3), Antti Ahokas (a4), Ivan Eggens (a5), Sherry Liu (a6) and Hans Eriksson (a6)
  • DOI:
  • Published online: 20 August 2009

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.

Corresponding author
Address for correspondence: Professor Dr B. Bandelow, Department of Psychiatry and Psychotherapy, University of Goettingen, Von-Siebold-Str. 5, D-37075Goettingen, Germany. Tel.: +49-551-396607Fax: +49-551-398952Email:
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The International Journal of Neuropsychopharmacology
  • ISSN: 1461-1457
  • EISSN: 1469-5111
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