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Placebo response and antidepressant clinical trial outcome.
J Nerv Ment Dis 2003; 191(4):211-8JN

Abstract

Placebo response magnitude is suspected to affect the outcome of antidepressant clinical trials. To evaluate this, 52 randomized, double-blind, placebo-controlled clinical trials obtained from the FDA were examined to correlate placebo response magnitude with trial outcome. The magnitude of symptom reduction, percentage mean change from baseline in the Hamilton Depression Rating Scale (HAM-D), was assessed for patients assigned to placebo or an antidepressant. Correlation coefficients between symptom reduction with placebo and antidepressants and between symptom reduction with placebo and magnitude of advantage of antidepressants over placebo were assessed. A statistically significant positive correlation was seen between placebo and antidepressant response magnitude (r =.40, p <.001) and between placebo response magnitude and the advantage of antidepressants over placebo (r = -.592, p <.0001). Only 21.1% of antidepressant treatment arms in trials with high placebo response (>30% mean change from baseline) showed statistical superiority over placebo compared with 74.2% in trials with a low placebo response (< or =30). Response magnitude varies and has an important effect on antidepressant clinical trials, illustrating the need for a placebo arm to determine if the trial was sensitive to treatment differences and highlighting the dangers of cross-study comparisons.

Authors+Show Affiliations

Northwest Clinical Research Center, 1900 116th Avenue NE #112, Bellevue, Washington 98004, USA.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Meta-Analysis

Language

eng

PubMed ID

12695731

Citation

Khan, Arif, et al. "Placebo Response and Antidepressant Clinical Trial Outcome." The Journal of Nervous and Mental Disease, vol. 191, no. 4, 2003, pp. 211-8.
Khan A, Detke M, Khan SR, et al. Placebo response and antidepressant clinical trial outcome. J Nerv Ment Dis. 2003;191(4):211-8.
Khan, A., Detke, M., Khan, S. R., & Mallinckrodt, C. (2003). Placebo response and antidepressant clinical trial outcome. The Journal of Nervous and Mental Disease, 191(4), pp. 211-8.
Khan A, et al. Placebo Response and Antidepressant Clinical Trial Outcome. J Nerv Ment Dis. 2003;191(4):211-8. PubMed PMID: 12695731.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Placebo response and antidepressant clinical trial outcome. AU - Khan,Arif, AU - Detke,Michael, AU - Khan,Shirin R F, AU - Mallinckrodt,Craig, PY - 2003/4/16/pubmed PY - 2003/6/7/medline PY - 2003/4/16/entrez SP - 211 EP - 8 JF - The Journal of nervous and mental disease JO - J. Nerv. Ment. Dis. VL - 191 IS - 4 N2 - Placebo response magnitude is suspected to affect the outcome of antidepressant clinical trials. To evaluate this, 52 randomized, double-blind, placebo-controlled clinical trials obtained from the FDA were examined to correlate placebo response magnitude with trial outcome. The magnitude of symptom reduction, percentage mean change from baseline in the Hamilton Depression Rating Scale (HAM-D), was assessed for patients assigned to placebo or an antidepressant. Correlation coefficients between symptom reduction with placebo and antidepressants and between symptom reduction with placebo and magnitude of advantage of antidepressants over placebo were assessed. A statistically significant positive correlation was seen between placebo and antidepressant response magnitude (r =.40, p <.001) and between placebo response magnitude and the advantage of antidepressants over placebo (r = -.592, p <.0001). Only 21.1% of antidepressant treatment arms in trials with high placebo response (>30% mean change from baseline) showed statistical superiority over placebo compared with 74.2% in trials with a low placebo response (< or =30). Response magnitude varies and has an important effect on antidepressant clinical trials, illustrating the need for a placebo arm to determine if the trial was sensitive to treatment differences and highlighting the dangers of cross-study comparisons. SN - 0022-3018 UR - https://www.unboundmedicine.com/medline/citation/12695731/Placebo_response_and_antidepressant_clinical_trial_outcome_ L2 - http://dx.doi.org/10.1097/01.NMD.0000061144.16176.38 DB - PRIME DP - Unbound Medicine ER -