TY - JOUR
T1 - Characterizing the Placebo Response in Adults With ADHD
AU - Ben-Sheetrit, Joseph
AU - Peskin, Miriam
AU - Newcorn, Jeffrey H.
AU - Daniely, Yaron
AU - Shbiro, Liat
AU - Rotem, Ann
AU - Weizman, Abraham
AU - Manor, Iris
N1 - Publisher Copyright:
© The Author(s) 2018.
PY - 2020/2/1
Y1 - 2020/2/1
N2 - Objective: Several ADHD pharmacological trials reported high placebo response (PR) rates. This study aims to characterize the PR in adult ADHD. Method: A retrospective cohort analysis of the placebo arm (140 adults with ADHD, 18-55 yrs, M:F 46.4%-53.6%) of a 6-week randomized, multicenter, double-blind metadoxine study, using Conners’ Adult ADHD Rating Scale (CAARS) and the Adult ADHD Self-Report Scale (ASRS), was conducted. Results: Pre–post changes in placebo-treated adults were significant for both the CAARS and ASRS, F(2.9, 404.5) = 61.2, p <.00001, F(2.8, 383.0) = 43.1, p <.00001, respectively. Less than half of the participants had a PR which began early in treatment and persisted; almost 50% had a variable, inconsistent PR. Conclusion: In the current sample, PR in adult ADHD was prominent on both symptom scales and the investigator–rater instrument. Therefore, using investigator ratings as a primary endpoint does not necessarily attenuate PR. Of note, about half of the PR is variable, suggesting unreliable determination of efficacy.
AB - Objective: Several ADHD pharmacological trials reported high placebo response (PR) rates. This study aims to characterize the PR in adult ADHD. Method: A retrospective cohort analysis of the placebo arm (140 adults with ADHD, 18-55 yrs, M:F 46.4%-53.6%) of a 6-week randomized, multicenter, double-blind metadoxine study, using Conners’ Adult ADHD Rating Scale (CAARS) and the Adult ADHD Self-Report Scale (ASRS), was conducted. Results: Pre–post changes in placebo-treated adults were significant for both the CAARS and ASRS, F(2.9, 404.5) = 61.2, p <.00001, F(2.8, 383.0) = 43.1, p <.00001, respectively. Less than half of the participants had a PR which began early in treatment and persisted; almost 50% had a variable, inconsistent PR. Conclusion: In the current sample, PR in adult ADHD was prominent on both symptom scales and the investigator–rater instrument. Therefore, using investigator ratings as a primary endpoint does not necessarily attenuate PR. Of note, about half of the PR is variable, suggesting unreliable determination of efficacy.
KW - adult ADHD
KW - nocebo
KW - nonstimulants
KW - placebo
UR - http://www.scopus.com/inward/record.url?scp=85048959392&partnerID=8YFLogxK
U2 - 10.1177/1087054718780328
DO - 10.1177/1087054718780328
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C2 - 29926752
AN - SCOPUS:85048959392
SN - 1087-0547
VL - 24
SP - 425
EP - 433
JO - Journal of Attention Disorders
JF - Journal of Attention Disorders
IS - 3
ER -