Placebo Effects Across Self-Report, Clinician Rating, and Objective Performance Tasks among Women with Post-Traumatic Stress Disorder: Investigation of Placebo Response in a Pharmacological Treatment Study of Post-Traumatic Stress Disorder

Gabrielle E. Hodgins, Jared G. Blommel, Boadie W. Dunlop, Dan Iosifescu, Sanjay J. Mathew, Thomas C. Neylan, Helen S. Mayberg, Philip D Harvey

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Purpose/Background For a drug to acquire Food and Drug Administration approval, it must significantly outperform placebo treatment. In recent years, the placebo effect seems to be increasing in neuropsychiatric conditions. Here, we examine placebo effects across self-reported, clinically rated, and performance-based data from a trial using a corticotropin-releasing hormone receptor type 1 (CRHR1) antagonist for treatment of post-Traumatic stress disorder (PTSD). Methods/Procedures Women with chronic PTSD were randomized to treatment with either GSK561679, a CRHR1 antagonist, or placebo. Before randomization, participants completed self-report scales, clinician-rated measures of PTSD and depression symptoms, and objective tests of cognition and functioning. Differences in change scores on measures were compared between GSK561679 and placebo-Treated participants. Findings/Results GSK561679 failed to produce any significant improvement in the participants. A substantial placebo effect was observed in both self-report and clinical rating scales, with effect sizes up to 1.5 SD. No single variable predicted placebo-related changes. Notably, there was an improvement on objective performance measures of cognition that exceeded previous standards for practice effects. Implications/Conclusions Participants in this trial manifested retest effects on performance-based measures of cognition. Notably, they had minimal prior experience with performance-based assessments. Experiencing the structure and support of a clinical trial may have contributed to significant reductions in subject-reported and clinician-rated PTSD symptom levels. The improvement seen across all assessment domains was consistent with that seen in previous studies where the active treatments separated from placebo. Investigators conducting clinical trials treating PTSD patients should expect placebo effects and design studies accordingly.

Original languageEnglish (US)
Pages (from-to)200-206
Number of pages7
JournalJournal of Clinical Psychopharmacology
Volume38
Issue number3
DOIs
StatePublished - Jun 1 2018

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Placebo Effect
Task Performance and Analysis
Post-Traumatic Stress Disorders
Self Report
Placebos
Pharmacology
Cognition
Clinical Trials
Therapeutics
Drug Approval
United States Food and Drug Administration
Random Allocation
Research Personnel
Depression
Pharmaceutical Preparations
NBI 77860

Keywords

  • adrenocorticotropic hormone
  • child abuse
  • clinical trial
  • placebo
  • post-Traumatic stress disorder
  • women

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Pharmacology (medical)

Cite this

Placebo Effects Across Self-Report, Clinician Rating, and Objective Performance Tasks among Women with Post-Traumatic Stress Disorder : Investigation of Placebo Response in a Pharmacological Treatment Study of Post-Traumatic Stress Disorder. / Hodgins, Gabrielle E.; Blommel, Jared G.; Dunlop, Boadie W.; Iosifescu, Dan; Mathew, Sanjay J.; Neylan, Thomas C.; Mayberg, Helen S.; Harvey, Philip D.

In: Journal of Clinical Psychopharmacology, Vol. 38, No. 3, 01.06.2018, p. 200-206.

Research output: Contribution to journalArticle

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AU - Blommel, Jared G.

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AU - Iosifescu, Dan

AU - Mathew, Sanjay J.

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AU - Mayberg, Helen S.

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