Treatment for Adolescents With Depression Study (TADS): Safety Results.
Objective: To compare the rates of physical, psychiatric, and suicide-related events in adolescents with MDD treated with fluoxetine alone (FLX), cognitive-behavioral therapy (CBT), combination treatment (COMB), or placebo (PBO). Method: Safety assessments included adverse events (AEs) collected by...
| Published in: | Journal of the American Academy of Child & Adolescent Psychiatry Vol. 45; no. 12; pp. 1440 - 1456 |
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| Main Authors: | , , |
| Format: | Article |
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Elsevier Science
December 2006
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| Subjects: | |
| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ssf&AN=510678802&site=ehost-live header: @attributes: shortDbName: ssf uiTerm: 510678802 longDbName: Social Sciences Full Text (H.W. Wilson) uiTag: AN controlInfo: bkinfo: jinfo: jid: 08908567 JAM jtl: Journal of the American Academy of Child & Adolescent Psychiatry issn: 08908567 maglogo: N pubinfo: dt: December 2006 vid: 45 iid: 12 pid: 467 pub: Elsevier Science artinfo: ui: 510678802 10.1097/01.chi.0000240840.63737.1d ppf: 1440 ppct: 16 formats: tig: atl: Treatment for Adolescents With Depression Study (TADS): Safety Results. aug: au: Emslie, Graham Kratochvil, Christopher Vitiello, Benedetto su: Care of youth with mental illness Mental depression Therapeutics Health Complaints & complaining Teenage suicide sug: subj: Care of youth with mental illness Mental depression Therapeutics Health Complaints & complaining Teenage suicide keyword: Emotionally disturbed adolescents -- Care Physical complaints ab: Objective: To compare the rates of physical, psychiatric, and suicide-related events in adolescents with MDD treated with fluoxetine alone (FLX), cognitive-behavioral therapy (CBT), combination treatment (COMB), or placebo (PBO). Method: Safety assessments included adverse events (AEs) collected by spontaneous report, as well as systematic measures for specific physical and psychiatric symptoms. Suicidal ideation and suicidal behavior were systematically assessed by self- and clinician reports. Suicidal events were also reanalyzed by the Columbia Group and expert raters using the Columbia- Classification Algorithm for Suicidal Assessment used in the U.S. Food and Drug Administration reclassification effort. Results: Depressed adolescents reported high rates of physical symptoms at baseline, which improved as depression improved. Sedation, insomnia, vomiting, and upper abdominal pain occurred in at least 2% of those treated with FLX and/or COMB and at twice the rate of placebo. The rate of psychiatric AEs was 11% in FLX, 5.6% in COMB, 4.5% in PBO, and 0.9% in CBT. Suicidal ideation improved overall, with greatest improvement in COMB. Twenty-four suicide-related events occurred during the 12-week period: 5 patients (4.7%) in COMB, 10 (9.2%) in FLX, 5 (4.5%) in CBT, and 3 (2.7%) in placebo. Statistically, only FLX had more suicide-related events than PBO (p = .0402, odds ratio [OR] = 3.7, 95% Cl 1.00-13.7). Only five actual attempts occurred (2 COMB, 2 FLX, 1 CBT, 0 PBO). There were no suicide completions. Conclusions: Different methods for eliciting AEs produce different results. In general, as depression improves, physical complaints and suicidal ideation decrease in proportion to treatment benefit. In this study, psychiatric AEs and suicide-related events are more common in FLX-treated patients. COMB treatment may offer a more favorable safety profile than medication alone in adolescent depression. J. Am. Acad. Child Adolesc. Psychiatry, 2006;45(12):1440-1455. Reprinted by permission of the publisher. pubtype: Academic Journal doctype: Article src: R language: English refInfo: copyright: @attributes: flag: N holdings: @attributes: islocal: N |
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