title: Quetiapine fumarate augmentation for patients with a primary anxiety disorder or a mood disorder: a pilot study.
abstract: BACKGROUND
  Comorbid anxiety symptoms,in patients with a primary anxiety disorder or a mood disorder, leads to poor patient outcomes and burdens the healthcare system. This pilot study evaluated the feasibility of extended-release quetiapine fumarate (quetiapine XR) for the treatment of patients with either a primary anxiety disorder or a mood disorder with comorbid anxiety symptoms compared to a placebo, as an adjunct to antidepressant therapy.
  
  
  METHODS
  Thirty-nine patients with a diagnosis of a primary anxiety disorder or a mood disorder with comorbid anxiety symptoms were enrolled in this study. Patients with a stable dose of antidepressant therapy were randomized according to a 2:1 probability of receiving either quetiapine XR or a placebo adjunctive treatment for 8 weeks. The efficacy was assessed by the Hamilton Anxiety Rating Scale (HAM-A) and the Clinical Global Impression of severity (CGI-S) score at baseline, week 1, 4, and 8.
  
  
  RESULTS
  A total of 35 patients were included in this intention-to treat (ITT) population for the efficacy analysis (quetiapine XR: 22 patients; placebo: 13 patients). At week 4, statistically significant differences were observed on both the HAM-A score (p = 0.003) and the CGI-S score (p = 0.025), favouring the quetiapine XR (-13.00 ± 4.14) compared to placebo (-6.63 ± 5.42). However, no statistically significant difference was observed between the two groups with regard to changes from the baseline to week 8 on the HAM-A score (p = 0.332) or the CGI-S score (p = 0.833).
  
  
  CONCLUSIONS
  Augmentation of antidepressant treatment with quetiapine XR did not result in clinical improvement according to the outcome measure of anxiety using the HAM-A and CGI-S scores at week 8, among the patients with either a primary anxiety disorder or a mood disorder with comorbid anxiety symptoms. However, treatment with quetiapine XR as an adjunct to antidepressant therapy appeared to provide a short-term benefit at 4 weeks. Further study is needed with a larger sample size, randomized controlled design and control of the dosage prescribed.
  
  
  BACKGROUND
  Clinicaltrials.gov identifier: NCT00912535.
authors.affiliation: Department of Psychiatry, Chang Gung Memorial Hospital at Keelung, Keelung, Taiwan.
authors.forename: Yi-Chih
authors.initials: YC
authors.lastname: Chen
authors.forename: Chih-Ken
authors.initials: CK
authors.lastname: Chen
authors.forename: Liang-Jen
authors.initials: LJ
authors.lastname: Wang
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001008:Anxiety Disorders / Q000188:drug therapy* / Q000453:epidemiology; D015897:Comorbidity; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects; D003987:Dibenzothiazepines / Q000008:administration & dosage* / Q000009:adverse effects; D004357:Drug Synergism; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019964:Mood Disorders / Q000188:drug therapy* / Q000453:epidemiology; D010865:Pilot Projects; D000069348:Quetiapine Fumarate
chemical_list: D000928:Antidepressive Agents; D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D003987:Dibenzothiazepines; D000069348:Quetiapine Fumarate