title: Randomized, placebo-controlled trial of quetiapine XR and divalproex ER monotherapies in the treatment of the anxious bipolar patient.
abstract: BACKGROUND
  Anxiety disorders complicate the treatment of bipolar disorder but are seldom the focus of bipolar treatment studies.
  
  
  METHODS
  The anxiolytic effect of quetiapine XR 50-300 mg/day compared to divalproex ER (500-3000 mg/day) was tested in an 8-week, double-blind, placebo-controlled, randomized clinical trial in 149 patients with bipolar disorder and a co-occurring panic disorder or GAD. The primary efficacy measure was the Clinician Global Improvement-21 Anxiety Scale (CGI-21). Secondary measures included the Hamilton Anxiety Scale (HAM-A) and Sheehan Panic Disorder Scale (SPS).
  
  
  RESULTS
  Repeated measures last-observation-carried-forward (LOCF) analyses of variance demonstrated significant treatment-by-time interaction effects on 3 of the 4 anxiety measures. Quetiapine XR at a mean endpoint dose of 186 mg/day produced rapid sustained improvements relative to baseline, divalproex ER and placebo on anxiety. Mean baseline-to-endpoint improvement was significantly greater for quetiapine XR compared to divalproex ER and placebo on the HAM-A and SPS. Both active medications were well tolerated, but weight gain was higher on quetiapine XR.
  
  
  CONCLUSIONS
  The study was limited to 8 weeks and to patients with bipolar disorder and comorbid panic disorder or GAD. The results may not be applicable to quetiapine XR as an add-on treatment to mood stabilizers or to bipolar disorder comorbid with other anxiety disorders.
  
  
  CONCLUSIONS
  Quetiapine XR in a dose range of 50-300 mg/day appears to reduce anxiety in bipolar patients with comorbid panic disorder or GAD treated for 8 weeks. The efficacy of other second-generation antipsychotics and mood stabilizers in patients with bipolar disorder and a co-occurring anxiety disorder should be investigated in double-blind, placebo-controlled studies.
authors.affiliation: Clinical and Translational Science Institute, University of South Florida, College of Medicine, 3515 East Fletcher Ave, Tampa, FL 33613, USA. dsheehan@health.usf.edu
authors.forename: David V
authors.initials: DV
authors.lastname: Sheehan
authors.forename: Kathy
authors.initials: K
authors.lastname: Harnett-Sheehan
authors.forename: Rosario B
authors.initials: RB
authors.lastname: Hidalgo
authors.forename: Juris
authors.initials: J
authors.lastname: Janavs
authors.forename: Susan L
authors.initials: SL
authors.lastname: McElroy
authors.forename: Darlene
authors.initials: D
authors.lastname: Amado
authors.forename: Trisha
authors.initials: T
authors.lastname: Suppes
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001714:Bipolar Disorder / Q000150:complications / Q000188:drug therapy*; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D003987:Dibenzothiazepines / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016584:Panic Disorder / Q000150:complications / Q000188:drug therapy*; D000069348:Quetiapine Fumarate; D016896:Treatment Outcome; D014635:Valproic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D015430:Weight Gain
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D003987:Dibenzothiazepines; D000069348:Quetiapine Fumarate; D014635:Valproic Acid