Cited by 456Treatment of Major DepressionPain Management and Placebo EffectAnxiety, Depression, Psychometrics, Treatment, Cognitive Processes

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Severity of Depression and Response to Antidepressants and Placebo: An Analysis of the Food and Drug Administration Database

Khan, Arif, Leventhal, Robyn M., Khan, Shirin R., Brown, Walter A.·2002·Journal of Clinical Psychopharmacology

DOI 10.1097/00004714-200202000-00007

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Abstract

Some studies suggest that more severely ill patients with depression respond well to antidepressants and poorly to placebo, whereas those who are mildly ill respond equally well to antidepressants and placebo. This notion has implications for the design of clinical trials. To further assess and substantiate these putative predictors of antidepressant and placebo response, we assessed the Food and Drug Administration database of 45 phase II and III antidepressant clinical trials. The frequency of statistically significant differences between antidepressants and placebo was higher in the trials that included patients with more severe depression. In the antidepressant-treated groups, the magnitude of symptom reduction was significantly related to mean initial Hamilton Rating Scale for Depression (HAM-D) score; the higher the mean initial HAM-D score, the larger the change. With placebo treatment, however, the higher the mean initial HAM-D score, the smaller the change. Early discontinuation was more frequent among patients whose mean initial HAM-D scores were higher. These data may help inform the design of future antidepressant clinical trials.

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Authors: Khan, A., Leventhal, R. M., Khan, S. R., & Brown, W. A.
Affiliations: Northwest Clinical Research Center (US)
Tufts University (US)
Corresponding author: Khan, Arif
Leventhal, Robyn M.
Khan, Shirin R.
ORCID: Khan, Arif
Brown, Walter A.
Venue: Journal of Clinical Psychopharmacology
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2002-02
Volume: 22
Issue: 1
Pages: 40-45
ISSN: 0271-0749 (ISSN-L)
DOI: 10.1097/00004714-200202000-00007
OpenAlex: W2094608167
Cited by: 456
References: 21
Citations by year: 2026: 5 · 2025: 7 · 2024: 6 · 2023: 13 · 2022: 13 · 2021: 10 · 2020: 14 · 2019: 28 · 2018: 18 · 2017: 21 · 2016: 18 · 2015: 33 · 2014: 41 · 2013: 20 · 2012: 27
FWCI: 10.78
Type: journal article
Language: en
Open access: closed
Locations: Journal of Clinical Psychopharmacology (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
Keywords: depression severity, antidepressant response, placebo response, antidepressant clinical trials, trial design, Hamilton Depression Rating Scale, treatment discontinuation, symptom relief
MeSH terms: Adolescent, Adult, Antidepressive Agents, Depressive Disorder, Double-Blind Method, Humans, Personality Inventory, United States, United States Food and Drug Administration, Placebo Effect, Randomized Controlled Trials as Topic, Databases, Factual, Treatment Outcome, Clinical Trials, Phase II as Topic, Clinical Trials, Phase III as Topic

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Severity of Depression and Response to Antidepressants and Placebo: An Analysis of the Food and Drug Administration Database

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