Myths of Randomized Controlled Trial Analysis in Pediatric Psychopharmacology

Asarnow JR , Emslie G , Clarke G , et al. Treatment of selective serotonin reuptake inhibitor-resistant depression in adolescents: Predictors and moderators of treatment response. J Am Acad Child Adolesc Psychiatry, 2009; 48(3):330–339; doi: 10.1097/CHI.0b013e3181977476

Bothwell LE , Greene JA , Podolsky SH , et al. Assessing the gold standard—lessons from the history of RCTs. N Engl J Med, 2016; 374(22):2175–2181; doi: 10.1056/NEJMms1604593

Brent D , Emslie G , Clarke G , et al. Switching to another SSRI or to Venlafaxine with or without cognitive behavioral therapy for adolescents with SSRI-Resistant Depression: The TORDIA randomized controlled trial. JAMA, 2008; 299(8):901–913; doi: 10.1001/jama.299.8.901

Clayton A . Bernoulli’s Fallacy. Columbia University Press; 2021.

Compton SN , Peris TS , Almirall D , et al. Predictors and moderators of treatment response in childhood anxiety disorders: Results from the CAMS trial. J Consult Clin Psychol, 2014; 82(2):212–224; doi: 10.1037/a0035458

Durgam S , Chen C , Migliore R , et al. A Phase 3, Double-blind, randomized, placebo-controlled study of Vilazodone in adolescents with major depressive disorder. Paediatr Drugs, 2018; 20(4):353–363; doi: 10.1007/s40272-018-0290-4

Emslie GJ , Ventura D , Korotzer A , et al. Escitalopram in the treatment of adolescent depression: A randomized placebo-controlled multisite trial. J Am Acad Child Adolesc Psychiatry, 2009; 48(7):721–729; doi: 10.1097/CHI.0b013e3181a2b304

Findling RL , Chang K , Robb A , et al. Adjunctive maintenance lamotrigine for pediatric Bipolar i Disorder: A placebo-controlled, randomized withdrawal study. J Am Acad Child Adolesc Psychiatry, 2015; 54(12):1020–1031.e3; doi: 10.1016/j.jaac.2015.09.017

Findling RL , McCusker E , Strawn JR . A randomized, double-blind, placebo-controlled trial of vilazodone in children and adolescents with major depressive disorder with twenty-six-week open-label follow-up. J Child Adolesc Psychopharmacol, 2020; 30(6):355–365; doi: 10.1089/cap.2019.0176

Gelman A , Carlin JB , Stern HS , et al. Bayesian Data Analysis. CRC Press: Boca Raton, FL; 2014.

Ioannidis JP . Why most published research findings are false. PLoS Med, 2005; 2(8):e124; doi: 10.1371/journal.pmed.0020124

Lewis RJ , Angus DC . Time for clinicians to embrace their inner Bayesian? JAMA – Journal of the American Medical Association, 2018; 320(21):2208–2210; doi: 10.1001/jama.2018.16916

Machin D , Fayers PM , Tai BC . Randomised Clinical Trials: Design, Practice and Reporting. John Wiley & Sons Ltd; 2021; doi: 10.1002/9781119524687

March J , Silva S , Petrycki S , et al; Treatment for Adolescents With Depression Study (TADS) Team. Fluoxetine, Cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. JAMA: The Journal of the American Medical Association, 2004; 292(7):807–820; doi: 10.1001/jama.292.7.807

McGlothlin AE , Viele K . Bayesian hierarchical models. JAMA – Journal of the American Medical Association, 2018; 320(22):2365–2366; doi: 10.1001/jama.2018.17977

Mossman SA , Mills JA , Walkup JT , et al. The impact of failed antidepressant trials on outcomes in children and adolescents with anxiety and depression: A systematic review and meta-analysis. J Child Adolesc Psychopharmacol, 2021; 31(4):259–267; doi: 10.1089/cap.2020.0195

Riesenberg R , Yeung PP , Rekeda L , et al. Cariprazine for the adjunctive treatment of major depressive disorder in patients with inadequate response to antidepressant therapy: Results of a randomized, double-blind, placebo-controlled study. J Clin Psychiatry, 2023; 84(5); doi: 10.4088/JCP.22M14643

Rush AJ , Trivedi MH , Stewart JW , et al. Combining medications to enhance depression Outcomes (CO-MED): Acute and long-term outcomes of a single-blind randomized study. Ajp, 2011; 168(7):689–701; doi: 10.1176/appi.ajp.2011.10111645

Sachs GS , Yeung PP , Rekeda L , et al. Adjunctive cariprazine for the treatment of patients with major depressive disorder: A randomized, double-blind, placebo-controlled Phase 3 study. Am J Psychiatry, 2023; 180(3):241–251; doi: 10.1176/appi.ajp.20220504

Saito T , Takahashi H , Tsujii N , et al. Efficacy of preventing relapse evaluated by a multicenter randomized double-blind placebo-controlled withdrawal study of escitalopram in Japanese adolescents with major depressive disorder. J Child Adolesc Psychopharmacol, 2023; 33(10):418–427; doi: 10.1089/cap.2023.0048

Stahl SM , Strawn JR . Prescriber's guide – children and adolescents. Second Edition. Cambridge University Press. 2024. New York, NY.

Strawn JR , Mills JA , Schroeder H , et al. Escitalopram in adolescents with generalized anxiety disorder: A double-blind, randomized, placebo-controlled study. J Clin Psychiatry, 2020; 81(5); doi: 10.4088/JCP.20m13396

Strawn JR , Moldauer L , Hahn RD , et al. A multicenter double-blind, placebo-controlled trial of escitalopram in children and adolescents with generalized anxiety disorder. J Child Adolesc Psychopharmacol, 2023; 33(3):91–100; doi: 10.1089/cap.2023.0004

Suresh V , Mills JA , Croarkin PE , et al. What next? A Bayesian hierarchical modeling re-examination of treatments for adolescents with selective serotonin reuptake inhibitor-resistant depression. Depress Anxiety, 2020; 37(9):926–934; doi: 10.1002/da.23064

Walkup JT , Albano AM , Piacentini J , et al. Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. N Engl J Med, 2008; 359(26):2753–2766; doi: 10.1056/NEJMoa0804633