Deconstructing Pediatric Depression Trials: An Analysis of the Effects of Expectancy and Therapeutic Contact - 28/07/11
, Joel R. Sneed, Ph.D. b, Jane M. Tandler, H.S. c, David Rindskopf, Ph.D. d, Bradley S. Peterson, M.D. a, c, Steven P. Roose, M.D. a
Correspondence to Bret R Rutherford, M.D., Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, 1051 Riverside Drive, Box 98, New York, NY 10032Résumé |
Objective |
This study investigated how study type, mean patient age, and amount of contact with research staff affected response rates to medication and placebo in acute antidepressant trials for pediatric depression.
Method |
Data were extracted from nine open, four active comparator, and 18 placebo-controlled studies of antidepressants for children and adolescents with depressive disorders. A multilevel meta-analysis examined how study characteristics affected response rates to antidepressants and placebo.
Results |
The primary finding was a main effect of study type across patient age and contact amount, such that the odds of medication response were greater in open versus placebo-controlled studies (odds ratio 1.87, 95% confidence interval 1.17–2.99, p = .012) and comparator studies (odds ratio 2.01, 95% confidence interval 1.16–3.48, p = .015) but were not significantly different between comparator and placebo-controlled studies. No significant main effects of patient age or amount of contact with research staff were found for analyses of response rates to medication and placebo. Response to placebo in placebo-controlled trials did significantly increase with the amount of therapeutic contact in older patients (age by contact; odds ratio 1.08, 95% confidence interval 1.01–1.15, p = .038).
Conclusions |
Although patient expectancy strongly influences response rates to medication and placebo in depressed adults, it appears to be less important in the treatment of children and adolescents with depression. Attempts to limit placebo response and improve the efficiency of antidepressant trials for pediatric depression should focus on other causes of placebo response apart from expectancy.
Le texte complet de cet article est disponible en PDF.Key Words : major depressive disorder, expectancy, placebo effect, randomized controlled trial, antidepressant
Plan
| This work was supported by National Institute of Mental Health grants K23 MH085236 (B.R.R.), K23 MH075006 (J.R.S.), R21 MH087774 (J.R.S.), MH36197 (B.S.P.), and K02-74677 (B.S.P.), a Hope for Depression Research Foundation grant (B.R.R.), and a National Alliance for Research on Schizophrenia and Depression Young Investigator Award (B.R.R.). |
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| Disclosure: Dr. Roose has served on a Data and Safety Monitoring Board for Medtronics, Inc. Drs. Rutherford, Sneed, Rindskopf, and Peterson and Ms. Tandler report no biomedical financial interests or potential conflicts of interest. |
Vol 50 - N° 8
P. 782-795 - août 2011 Retour au numéro
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