Treatment for Adolescents with Depression Study (TADS): Safety Results

Autor/inn/en	Emslie, Graham; Kratochvil, Christopher; Vitiello, Benedetto; Silva, Susan; Mayes, Taryn; McNulty, Steven; Weller, Elizabeth; Waslick, Bruce; Casat, Charles; Walkup, John; Pathak, Sanjeev; Rohde, Paul; Posner, Kelly; March, John
Titel	Treatment for Adolescents with Depression Study (TADS): Safety Results
Quelle	In: Journal of the American Academy of Child and Adolescent Psychiatry, 45 (2006) 12, S.1440-1455 (16 Seiten) PDF als Volltext Verfügbarkeit
Sprache	englisch
Dokumenttyp	gedruckt; online; Zeitschriftenaufsatz
ISSN	0890-8567
Schlagwörter	Safety; Patients; Adolescents; Suicide; Pain; Depression (Psychology); Comparative Analysis; Symptoms (Individual Disorders); Drug Therapy; Pharmacology; Cognitive Restructuring; Behavior Modification; Outcomes of Treatment; Counseling Effectiveness; Sleep; Psychiatry; Psychological Patterns + Suchen Sie Ihr Suchwort? Sicherheit; Patient; Adolescent; Adolescence; Adoleszenz; Jugend; Jugendalter; Jugendlicher; Selbstmord; Schmerz; Psychiatrische Symptomatik; Arzneikunde; Behaviour modification; Verhaltensänderung; Schlaf; Psychiatrie
Abstract	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 = 0.0402, odds ratio [OR] = 3.7, 95% CI 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. (Contains 1 figure and 5 tables.) (Author).
Anmerkungen	Lippincott Williams & Wilkins. P.O. Box 1600, Hagerstown, MD 21741. Tel: 800-638-3030; Tel: 301-223-2300; Fax: 301-223-2400; Web site: http://www.lww.com/product/?0890-8567
Erfasst von	ERIC (Education Resources Information Center), Washington, DC
Update	2017/4/10