Baseline and 2- to 3-year follow-up characteristics of placebo-washout responders from the nortriptyline study of depressed 6- to 12-year-olds.

Abstract

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.

• Authors: B Geller, L W Fox, T B Cooper, K Garrity
• Journal: Journal of the American Academy of Child and Adolescent Psychiatry (J Am Acad Child Adolesc Psychiatry) Vol. 31 Issue 4 Pg. 622-8 (Jul 1992) ISSN: 0890-8567 [Print] United States
• PMID: 1644724 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Nortriptyline

Topics

• Bipolar Disorder (blood, drug therapy, psychology)
• Child
• Depressive Disorder (blood, drug therapy, psychology)
• Female
• Follow-Up Studies
• Humans
• Longitudinal Studies
• Male
• Nortriptyline (pharmacokinetics, therapeutic use)
• Personality Assessment
• Recurrence