title: INFLUENCE OF STUDY DESIGN ON TREATMENT RESPONSE IN ANXIETY DISORDER CLINICAL TRIALS.
abstract: OBJECTIVE
  The influence of study design variables and publication year on response to medication and placebo was investigated in clinical trials for social anxiety disorder (SAD), generalized anxiety disorder (GAD), and panic disorder (PD).
  
  
  METHODS
  Hierarchical linear modeling determined whether publication year, treatment assignment (medication vs. placebo), study type (placebo-controlled or active comparator), study duration, and the number of study visits affected the mean change associated with medication and placebo.
  
  
  RESULTS
  In the 66 trials examined, the change associated with both medication and placebo increased over time (t = 4.23, df = 39, P < .001), but average drug-placebo differences decreased over time (t = -2.04, df = 46, P = .047). More severe baseline illness was associated with greater drug-placebo differences for serotonin norepinephrine reuptake inhibitors (SNRIs, t = 3.46, df = 106, P = .001) and selective serotonin reuptake inhibitors (SSRI, t = 10.37, df = 106, P < .001). Improvement with medication was significantly greater in active-comparator studies compared to placebo-controlled trials (t = 3.41, df = 39, P = .002). A greater number of study visits was associated with greater symptom improvement in PD trials relative to SAD (t = 2.83, df = 39, P = .008) and GAD (t = 2.16, df = 39, P = .037).
  
  
  CONCLUSIONS
  Placebo response is substantial in SAD, GAD, and PD trials, and its rise over time has been associated with diminished drug-placebo differences. Study design features that influence treatment response in anxiety disorder trials include patient expectancy, frequency of follow-up visits, and baseline illness severity.
authors.affiliation: Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, New York, New York.
authors.forename: Bret R
authors.initials: BR
authors.lastname: Rutherford
authors.affiliation: New York State Psychiatric Institute, New York, New York.
authors.forename: Veronika S
authors.initials: VS
authors.lastname: Bailey
authors.affiliation: Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, New York, New York.
authors.forename: Franklin R
authors.initials: FR
authors.lastname: Schneier
authors.affiliation: New York State Psychiatric Institute, New York, New York.
authors.forename: Emily
authors.initials: E
authors.lastname: Pott
authors.affiliation: Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, New York, New York.
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Brown
authors.affiliation: Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, New York, New York.
authors.forename: Steven P
authors.initials: SP
authors.lastname: Roose
mesh_terms: D000328:Adult; D001008:Anxiety Disorders / Q000188:drug therapy*; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D016584:Panic Disorder / Q000188:drug therapy; D016032:Randomized Controlled Trials as Topic; D012107:Research Design / Q000706:statistics & numerical data*; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*
chemical_list: D017367:Selective Serotonin Reuptake Inhibitors
keywords: antidepressants; anxiety/anxiety disorder; clinical trials; pharmacotherapy; treatment