title: Role of pill-taking, expectation and therapeutic alliance in the placebo response in clinical trials for major depression.
abstract: BACKGROUND
  Pill-taking, expectations and therapeutic alliance may account for much of the benefit of medication and placebo treatment for major depressive disorder (MDD). Aims To examine the effects of medication, placebo and supportive care on treatment outcome, and the relationships of expectations and therapeutic alliance to improvement.
  
  
  METHODS
  A total of 88 participants were randomised to 8 weeks of treatment with supportive care alone or combined with double-blind treatment with placebo or antidepressant medication. Expectations of medication effectiveness, general treatment effectiveness and therapeutic alliance were measured (trial registration at ClinicalTrials.gov: NCT00200902).
  
  
  RESULTS
  Medication or placebo plus supportive care were not significantly different but had significantly better outcome than supportive care alone. Therapeutic alliance predicted response to medication and placebo; expectations of medication effectiveness at enrolment predicted only placebo response.
  
  
  CONCLUSIONS
  Pill treatment yielded better outcome than supportive care alone. Medication expectations uniquely predicted placebo treatment outcome and were formed by time of enrolment, suggesting that they were shaped by prior experiences outside the clinical trial.
authors.affiliation: Andrew F. Leuchter, MD, Aimee M. Hunter, PhD, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA and the Laboratory of Brain, Behavior, and Pharmacology, Semel Institute for Neuroscience and Human Behavior at UCLA, Los Angeles; Molly Tartter, MA, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, the Laboratory of Brain, Behavior, and Pharmacology, Semel Institute for Neuroscience and Human Behavior at UCLA and the Department of Psychology, University of California Los Angeles, Los Angeles; Ian A. Cook, MD, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA and the Laboratory of Brain, Behavior, and Pharmacology, Semel Institute for Neuroscience and Human Behavior at UCLA, Los Angeles, California, USA.
authors.forename: Andrew F
authors.initials: AF
authors.lastname: Leuchter
authors.affiliation: Andrew F. Leuchter, MD, Aimee M. Hunter, PhD, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA and the Laboratory of Brain, Behavior, and Pharmacology, Semel Institute for Neuroscience and Human Behavior at UCLA, Los Angeles; Molly Tartter, MA, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, the Laboratory of Brain, Behavior, and Pharmacology, Semel Institute for Neuroscience and Human Behavior at UCLA and the Department of Psychology, University of California Los Angeles, Los Angeles; Ian A. Cook, MD, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA and the Laboratory of Brain, Behavior, and Pharmacology, Semel Institute for Neuroscience and Human Behavior at UCLA, Los Angeles, California, USA.
authors.forename: Aimee M
authors.initials: AM
authors.lastname: Hunter
authors.affiliation: Andrew F. Leuchter, MD, Aimee M. Hunter, PhD, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA and the Laboratory of Brain, Behavior, and Pharmacology, Semel Institute for Neuroscience and Human Behavior at UCLA, Los Angeles; Molly Tartter, MA, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, the Laboratory of Brain, Behavior, and Pharmacology, Semel Institute for Neuroscience and Human Behavior at UCLA and the Department of Psychology, University of California Los Angeles, Los Angeles; Ian A. Cook, MD, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA and the Laboratory of Brain, Behavior, and Pharmacology, Semel Institute for Neuroscience and Human Behavior at UCLA, Los Angeles, California, USA.
authors.forename: Molly
authors.initials: M
authors.lastname: Tartter
authors.affiliation: Andrew F. Leuchter, MD, Aimee M. Hunter, PhD, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA and the Laboratory of Brain, Behavior, and Pharmacology, Semel Institute for Neuroscience and Human Behavior at UCLA, Los Angeles; Molly Tartter, MA, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, the Laboratory of Brain, Behavior, and Pharmacology, Semel Institute for Neuroscience and Human Behavior at UCLA and the Department of Psychology, University of California Los Angeles, Los Angeles; Ian A. Cook, MD, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA and the Laboratory of Brain, Behavior, and Pharmacology, Semel Institute for Neuroscience and Human Behavior at UCLA, Los Angeles, California, USA.
authors.forename: Ian A
authors.initials: IA
authors.lastname: Cook
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D003131:Combined Modality Therapy / Q000379:methods / Q000523:psychology; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000523:psychology / Q000628:therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007406:Interview, Psychological; D008297:Male; D008875:Middle Aged; D009042:Motivation; D010349:Patient Compliance; D015990:Placebo Effect; D011569:Psychiatric Status Rating Scales; D011613:Psychotherapy / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents