Predictors of placebo response in randomized controlled trials of psychotropic drugs for children and adolescents with internalizing disorders

Journal of Child and Adolescent Psychopharmacology

Volumn 20, Issue 1, 2010, Pages 39-47

  Cohen, David ^a,b   Consoli, Angèle ^a,b   Bodeau, Nicolas ^a   Purper Ouakil, Diane ^c   Deniau, Emmanuelle ^a   Guile, Jean Marc ^a,b,d   Donnelly, Craig ^e  

^a SORBONNE UNIVERSITÉ   (France)

^b CNRS   (France)

^c UNIVERSITÉ PARIS DESCARTES   (France)

^d UNIVERSITÉ DE MONTRÉAL   (Canada)

^e DARTMOUTH MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; PSYCHOTROPIC AGENT;

ANXIETY DISORDER; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEMOGRAPHY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; HUMAN; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; OBSESSIVE COMPULSIVE DISORDER; PLACEBO EFFECT; POSTTRAUMATIC STRESS DISORDER; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; TREATMENT RESPONSE;

ADOLESCENT; ANXIETY DISORDERS; CHILD; DEPRESSIVE DISORDER, MAJOR; HUMANS; OBSESSIVE-COMPULSIVE DISORDER; PLACEBO EFFECT; PSYCHOTROPIC DRUGS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; STRESS DISORDERS, POST-TRAUMATIC; TREATMENT OUTCOME;

EID: 77249109450     PISSN: 10445463     EISSN: None     Source Type: Journal    
DOI: 10.1089/cap.2009.0047     Document Type: Article

References (42)

1. rd edition (DSM-III). Washington (DC): American Psychiatric Association 1980.
2. Birmaher B, Brent D: AACAP Work Group on Quality Issues et al: Practice parameter for the assessment and treatment of children and adolescents with depressive disorders. J Am Acad Child Adolesc Psychiatry 46:1503-1526, 2007.
3. Brent DA, Holder D, Kolko D, Birmaher B, Baugher M, et al: A clinical psychotherapy trial for adolescent depression comparing cognitive, family and supportive treatments. Arch Gen Psychiatry 54:877-885, 1997.
4. Bridge JA, Iyengar S, Salary CB, Barbe RP, Birmaher B, Pincus HA, Ren L, Brent DA: Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: A meta-analysis of randomized controlled trials. JAMA 297:1683-1696, 2007.
5. Bridge JA, Birmaher B, Iyengar S, Barbe RP, Brent DA: A Placebo response in randomized controlled trials of antidepressants for pediatric major depressive disorder. Am J Psychiatry 166:42-49, 2009. Brophy B: Kindergarteners in Prozac nation. US News and World Report 13:96-97, 1995.
6. Brunoni AR, Lopes M, Kaptchuk TJ, Fregni F: Placebo response of non-pharmacological and pharmacological trials in major depression: A systematic review and meta-analysis. PlosOne 4:e4824, 2009.
7. Charney DS, Nemeroff CB, Lewis L, Laden SK, Gorman JM, Laska EM, Borenstein M, Bowden CL, Caplan A, Emslie GJ, Evans DL, Geller B, Grabowski LE, Herson J, Kalin NH, Keck PE, Jr., Kirsch I, Krishnan KR, Kupfer DJ, Makuch RW, Miller FG, Pardes H, Post R, Reynolds MM, Roberts L, Rosenbaum JF, Rosenstein DL, Rubinow DR, Rush AJ, Ryan ND, Sachs GS, Schatzberg AF, Solomon S., Consensus Development P: National Depressive and Manic-Depressive Association consensus statement on the use of placebo in clinical trials of mood disorders. Arch Gen Psychiatry 59:262-270, 2002.
8. Cohen D: Should the use of specific serotonine reuptake inhibitors be banned? Psychother Psychosom 76:5-14, 2007.
9. Cohen D, Deniau E, Maturana A, Tanguy ML, Bodeau N, Labelle R, Breton JJ, Guile JM: Why is placebo response higher in major depression than in anxiety disorders in children and adolescent? PlosOne 3:e2632, 2008.
10. Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbe KA: Incorporating variations in the quality of individual randomized trials into meta-analysis. J Clin Epidemiol 3:255-265, 1992.
11. Emslie, GJ: Editorial: Understanding placebo response in pediatric depression trials. Am J Psychiatry 166:1-3, 2009.
12. Enck P, Benedetti F, Schedlowski M: New insights into the placebo and nocebo responses. Neuron 59:195-206, 2008.
13. Flament M., Cohen D: Childhood obsessive compulsive disorders. In: Obsessive-Compulsive Disorder: Evidence and Practice. Maj M, Sartorius N, eds. Genève: Word Psychiatric Association, pp 147-183, 2000.
14. Flament MF, Cohen D, Choquet M, Jeammet Ph, Ledoux S: Phenomenology, psychosocial correlates and treatment seeking in major depression and dysthymia in adolescence. J Am Acad Child Adolesc Psychiatry 40:1070-1078, 2001.
15. Gelenberg AJ, Thase ME, Meyer RE, Goodwin FK, Katz MM, Kraemer HC, Potter WZ, Shelton RC, Fava M, Khan A, Trivedi MH, Ninan PT, Mann JJ, Bergeson S, Endicott J, Kocsis JH, Leon AC, Manji HK, Rosenbaum JF: The history and current state of antidepressant clinical trial design: A call to action for proof-ofconcept studies. J Clin Psychiatry 69:1513-1528, 2008.
16. Geller DA, Biederman J, Stewart SE, Mullin B, Martin A, Spencer T, Faraone SV: Which SSRI? A meta-analysis of pharmacotherapy trials in pediatric obsessive-compulsive disorder. Am J Psychiatry 160:1919-1928, 2003.
17. Goodyear I, Dubicka B, Wilkinson P, Kelvin R, Roberts C, Byford S, Breen S, Ford C, Barrett B, Leech A, Rothwell J, White L, Harrington R: Selective serotonin reuptake inhibitors (SSRIs) and routine specialist care with and without cognitive behaviour therapy in adolescents with major depression: Randomized controlled trial Br Med J 335:142, 2007.
18. Hammad TA, Laughren T, Racoosin J: Suicidality in pediatric patients treated with antidepressant drugs. Arch Gen Psychiatry 63:332-339, 2006.
19. Hetrick S, Merry S, McKenzie J, Sindahl P, Proctor M: Selective serotonin reuptake inhibitors (SSRIs) for depressive disorders in children and adolescents. Cochrane Database Syst Rev 3:CD004851, 2007.
20. Jaffee SR, Moffitt TE, Caspi A, Fombonne E, Poulton R: Martin JJ. Differences in early childhood risk factors for juvenile-onset and adult-onset depression. Arch Gen Psychiatry 59:215-222, 2002.
21. Jureidini JN, Doecke CJ, Mansfield PR, Haby MM, Menkes DB, Tonkin AL: Efficacy and safety of antidepressants for children and adolescents. BMJ 328:879-883, 2004.
22. Kapczinski F, Lima MS, Souza JS, Schmitt R: Antidepressants for generalized anxiety disorder. Cochrane Database Syst Rev 2:CD003592, 2003.
23. Keck PE, Jr., Welge JA, McElroy SL, Arnold LM, Strakowski SM: Placebo effect in randomized, controlled studies of acute bipolar mania and depression. Biol Psychiatry 47:748-755, 2000.
24. Kennard BD, Silva SG, Mayes TL, Rhode P, Hugues JL, Vitiello B, Kratochvil CJ, Curry JF, Emslie GJ, Reinecke MA, March J: Assessment of safety and long-term outcomes of initial treatment with placebo in TADS. Am J Psychiatry 166:337-344, 2009.
25. Khan A, Dager SR, Cohen S, Avery DH, Scherzo B, Dunner DL: Chronicity of depressive episode in relation to antidepressantplacebo response. Neuropsychopharmacology 4:125-130, 1991.
26. Khan A, Detke M, Khan SR et al: Placebo response and antidepressant clinical trial outcome. J Nerv Ment Dis 191:211-218, 2003.
27. Khan A, Schwartz K, Kolts RL et al: Relationship between depression severity entry criteria and antidepressant clinical trial outcomes. Biol Psychiatry 62:65-71, 2007.
28. Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT: Initial severity and antidepressant benefits: A metaanalysis of data submitted to the Food and Drug Administration. PLoS Med 5(2):e45, 2008.
29. Linde K, Witt CM, Streng A, Weidenhammer W, Wagenpfeil S, Brinkhaus B, Willich SN, Melchart D: The impact of pateint expectations on outcomes in four randomized controlled trials of acupuncture in patients chronic pain. Pain 128:264-271, 2007.
30. Macedo A, Banos JE, Farre M: Placebo response in the prophylaxis of migraine: A meta-analysis. Eur J Pain 12:68-75, 2008.
31. Mayes TL, Tao R, Rintelmann JW, Carmody T, Hughes CW, Kennard BD, Stewart SM, Emslie GJ: Do children and adolescents have differential response rates in placebo-controlled trials of fluoxetine? CNS Spectr 12:147-154, 2007.
32. Muratori F, Picchi L, Bruni G, Patarnello M, Romagnoli G: A two-year follow-up of psychodynamic psychotherapy for internalizing disorders in children. J Am Acad Child Adolesc Psychiatry 42:331-339, 2003.
33. Posternak MA, Zimmerman M: Therapeutic effect of follow-up assessments on antidepressant and placebo response rates in antidepressant efficacy trials: Meta-analysis. Br J Psychiatry 190:287-292, 2007.
34. Rohde P, Silva SG, Tonev ST, Kennard BD, Vitiello B, Kratochvil CJ, Reinecke MA: Curry JF, Simons AD, March JS. Achievement and maintenance of sustained response during TADS continuation and maintenance therapy. Arch Gen Psychiatry 65:447-455, 2008.
35. Ryan ND: Treatment of depression in children and adolescents. The Lancet 366:933-940, 2005.
36. Stein DJ, Baldwin DS, Dolberg OT, Despiegel N, Bandelow B: Which factors predict placebo response in anxiety disorders and major depression? An analysis of placebo controlled studies of escitalopram. J Clin Psychiatry 67:1741-1746, 2006.
37. Stevens J, Wang W, Fan L, Edwards MC, Campo JV, Gardner W. Parental attitudes toward children's use of antidepressants and psychotherapy. J Child Adolesc Psychopharmacol 19:289-296, 2009.
38. Sysko R, Walsh BT: A systematic review of placebo response in studies of bipolar mania. J Clin Psychiatry 68:1213-1217, 2007.
39. Trivedi MH, Trush H: (1994) Does a placebo run-in or a placebo treatment cell affect the efficacy of antidepressant medications? Neuropsychopharmacology 11:33-43, 1994.
40. Walsh BT, Seidman SN, Sysko R, Gould M: Placebo response in studies of major depression: Variable, substantial, and growing. JAMA 287:1840-1847, 2002.
41. Whittington CJ, Kendall T, Fonagy P, Cottrell D, Cotgrove A, Boddington E: Selective serotonin reuptake inhibitors in childhood depression: Systematic review of published versus unpublished data. Lancet 363:1341-1345, 2004.
42. Wilcox CS, Cohn JB, Linden RD, Heiser JF, Lucas PB, Morgan DL, DeFrancisco D: Predictors of placebo response: A retrospective analysis. Psychopharmacol Bull 28:157-162, 1992.