title: Efficacy and safety of quetiapine-XR as monotherapy or adjunctive therapy to a mood stabilizer in acute bipolar depression with generalized anxiety disorder and other comorbidities: a randomized, placebo-controlled trial.
abstract: OBJECTIVE
  To study the efficacy and safety of quetiapine-XR as monotherapy or adjunctive therapy to a mood stabilizer in acute bipolar I or II depression with comorbid generalized anxiety disorder (GAD) and other comorbidities.
  
  
  METHODS
  The study was conducted from January 2007 to November 2011. The Mini-International Neuropsychiatric Interview was used to ascertain the diagnosis of DSM-IV bipolar disorder, GAD, and other Axis I disorders. Eligible patients were randomly assigned to quetiapine-XR or placebo for up to 8 weeks. The Hamilton Depression Rating Scale-17 items (HDRS-17) was used as a primary outcome to evaluate the difference between the 2 groups using the change from baseline to end of study. Last observation carried forward and mixed-effects modeling for repeated measures were used to analyze the primary and secondary outcome measures.
  
  
  RESULTS
  Of the 120 patients screened, 100 patients were randomized to receive quetiapine-XR (n = 50) or placebo (n = 50). Twenty-six patients in the quetiapine-XR and 18 in the placebo group completed the study. The mean quetiapine-XR dose was 276 ± 50 mg/d (50-300 mg/d). There was no significant difference between the 2 groups in the change from baseline to end of study in HDRS-17 total score with an effect size of 0.19 favoring quetiapine-XR. There were also no significant differences between the 2 groups in secondary efficacy and safety outcome measures.
  
  
  CONCLUSIONS
  Quetiapine-XR was not significantly superior to placebo in bipolar I or II depression with GAD and other comorbidities, suggesting that data from relatively "pure" bipolar patients may not be generalizable to a highly comorbid population.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT00671853.
authors.affiliation: Department of Psychiatry, University Hospitals Case Medical Center/Case Western Reserve University School of Medicine, 10524 Euclid Ave, 12th floor, Cleveland, OH 44106 keming.gao@uhhospitals.org.
authors.forename: Keming
authors.initials: K
authors.lastname: Gao
authors.forename: Renrong
authors.initials: R
authors.lastname: Wu
authors.forename: David E
authors.initials: DE
authors.lastname: Kemp
authors.forename: Jun
authors.initials: J
authors.lastname: Chen
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Karberg
authors.forename: Carla
authors.initials: C
authors.lastname: Conroy
authors.forename: Philip
authors.initials: P
authors.lastname: Chan
authors.forename: Ming
authors.initials: M
authors.lastname: Ren
authors.forename: Mary Beth
authors.initials: MB
authors.lastname: Serrano
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Ganocy
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Calabrese
mesh_terms: D000208:Acute Disease; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D001008:Anxiety Disorders / Q000188:drug therapy* / Q000453:epidemiology; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000453:epidemiology; D015897:Comorbidity; D003692:Delayed-Action Preparations; D003987:Dibenzothiazepines / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004311:Double-Blind Method; D004357:Drug Synergism; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D000069348:Quetiapine Fumarate; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D003987:Dibenzothiazepines; D010919:Placebos; D000069348:Quetiapine Fumarate