Literature DB >> 21784298

Deconstructing pediatric depression trials: an analysis of the effects of expectancy and therapeutic contact.

Bret R Rutherford1, Joel R Sneed, Jane M Tandler, David Rindskopf, Bradley S Peterson, Steven P Roose.   

Abstract

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.
Copyright © 2011 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

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Year:  2011        PMID: 21784298      PMCID: PMC3143372          DOI: 10.1016/j.jaac.2011.04.004

Source DB:  PubMed          Journal:  J Am Acad Child Adolesc Psychiatry        ISSN: 0890-8567            Impact factor:   8.829


  56 in total

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2.  A randomized effectiveness trial of brief cognitive-behavioral therapy for depressed adolescents receiving antidepressant medication.

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Journal:  J Am Acad Child Adolesc Psychiatry       Date:  2005-09       Impact factor: 8.829

3.  Open trial of fluoxetine in children and adolescents with dysthymic disorder or double depression.

Authors:  B D Waslick; B T Walsh; L L Greenhill; M Eilenberg; L Capasso; D Lieber
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4.  Prediction of response to fluoxetine and placebo in children and adolescents with major depression: a hypothesis generating study.

Authors:  R A Kowatch; T J Carmody; G J Emslie; J W Rintelmann; C W Hughes; A J Rush
Journal:  J Affect Disord       Date:  1999-08       Impact factor: 4.839

5.  An open trial of citalopram in children and adolescents with depression.

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6.  Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial.

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Review 7.  Placebo response in randomized controlled trials of antidepressants for pediatric major depressive disorder.

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8.  Pharmacokinetically designed double-blind placebo-controlled study of nortriptyline in 6- to 12-year-olds with major depressive disorder.

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9.  An international, multicenter, placebo-controlled trial of paroxetine in adolescents with major depressive disorder.

Authors:  Ray Berard; Regan Fong; David J Carpenter; Christine Thomason; Christel Wilkinson
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10.  Subject expectations of treatment effectiveness and outcome of treatment with an experimental antidepressant.

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  23 in total

1.  Clinic visits in late-life depression trials: effects on signal detection and therapeutic outcome.

Authors:  Bret R Rutherford; Jane Tandler; Patrick J Brown; Joel R Sneed; Steven P Roose
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3.  Does differential drop-out explain the influence of study design on antidepressant response? A meta-analysis.

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Review 4.  Pain and placebo in pediatrics: a comprehensive review of laboratory and clinical findings.

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5.  INFLUENCE OF STUDY DESIGN ON TREATMENT RESPONSE IN ANXIETY DISORDER CLINICAL TRIALS.

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Review 6.  Placebo eff ects in psychiatry: mediators and moderators.

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7.  A Machine Learning Approach to Identifying Placebo Responders in Late-Life Depression Trials.

Authors:  Sigal Zilcha-Mano; Steven P Roose; Patrick J Brown; Bret R Rutherford
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Review 8.  Evidence-based treatments for youths with severely dysregulated mood: a qualitative systematic review of trials for SMD and DMDD.

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9.  Efficacy and Safety of Selective Serotonin Reuptake Inhibitors, Serotonin-Norepinephrine Reuptake Inhibitors, and Placebo for Common Psychiatric Disorders Among Children and Adolescents: A Systematic Review and Meta-analysis.

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Review 10.  A model of placebo response in antidepressant clinical trials.

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