Baseline and 2- to 3-year follow-up characteristics of placebo-washout responders from the nortriptyline study of depressed 6- to 12-year-olds.
Data are presented on the baseline characteristics and 2- to 3-year follow-up assessments of placebo-washout responders (PWRs) from a previously reported pharmacokinetically designed double-blind placebo-controlled trial of nortriptyline for major depressive disorder in 6- to 12-year-olds. Eleven of the 12 PWRs consented to participate in the follow-up study. At baseline, the only significant difference between the PWRs and the non-PWR subjects was that more females were PWRs. Notably, there were no significant differences with respect to severity, chronicity, age of onset, or comorbid psychopathology. The follow-up assessments showed that the rate of relapse to major depressive disorder and the rate of development of bipolarity were not significantly different for PWRs compared with non-PWRs. The authors discuss these findings vis-à-vis the adult literature and provide recommendations for the use of placebo-washout phases in future double-blind, placebo-controlled psychopharmacology trials in children.
Geller
B
B
Washington University School of Medicine, Department of Psychiatry, St. Louis, Mo 63110.
Fox
L W
LW
Cooper
T B
TB
Garrity
K
K
D001714:Bipolar Disorder / Q000097:blood / Q000188:drug therapy* / Q000523:psychology; D002648:Child; D003866:Depressive Disorder / Q000097:blood / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D009661:Nortriptyline / Q000493:pharmacokinetics / Q000627:therapeutic use*; D010552:Personality Assessment; D012008:Recurrence
D009661:Nortriptyline