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.
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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.)
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Chemical References |
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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
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