PMID- 19691907 OWN - NLM STAT- MEDLINE DCOM- 20100624 LR - 20161020 IS - 1469-5111 (Electronic) IS - 1461-1457 (Linking) VI - 13 IP - 3 DP - 2010 Apr TI - 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. PG - 305-20 LID - 10.1017/S1461145709990423 [doi] AB - 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. FAU - Bandelow, Borwin AU - Bandelow B AD - Department of Psychiatry and Psychotherapy, University of Goettingen, Germany. Borwin.Bandelow@medizin.uni-goettingen.de FAU - Chouinard, Guy AU - Chouinard G FAU - Bobes, Julio AU - Bobes J FAU - Ahokas, Antti AU - Ahokas A FAU - Eggens, Ivan AU - Eggens I FAU - Liu, Sherry AU - Liu S FAU - Eriksson, Hans AU - Eriksson H LA - eng SI - ClinicalTrials.gov/NCT00322595 PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20090820 PL - England TA - Int J Neuropsychopharmacol JT - The international journal of neuropsychopharmacology JID - 9815893 RN - 0 (Antipsychotic Agents) RN - 0 (Dibenzothiazepines) RN - 2S3PL1B6UJ (Quetiapine Fumarate) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Antipsychotic Agents/*therapeutic use MH - Anxiety Disorders/*drug therapy MH - Dibenzothiazepines/*therapeutic use MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Drug Administration Schedule MH - Drug Delivery Systems/methods MH - Female MH - Humans MH - Male MH - Middle Aged MH - Psychiatric Status Rating Scales MH - Quetiapine Fumarate MH - Treatment Outcome MH - Young Adult EDAT- 2009/08/21 09:00 MHDA- 2010/06/25 06:00 CRDT- 2009/08/21 09:00 PHST- 2009/08/21 09:00 [entrez] PHST- 2009/08/21 09:00 [pubmed] PHST- 2010/06/25 06:00 [medline] AID - S1461145709990423 [pii] AID - 10.1017/S1461145709990423 [doi] PST - ppublish SO - Int J Neuropsychopharmacol. 2010 Apr;13(3):305-20. doi: 10.1017/S1461145709990423. Epub 2009 Aug 20.