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

• NCJ Number: 216594
• Journal: Journal of the American Academy of Child & Adolescent Psychiatry Volume: 45 Issue: 12 Dated: December 2006 Pages: 1440-1455
• Author(s): Graham Emslie M.D.; Christopher Kratochvil M.D.; Benedetto Vitiello M.D.; Susan Silva Ph.D.; Taryn Mayes M.S.; Steven McNulty M.S.; Elizabeth Weller M.D.; Bruce Waslick M.D.; Charles Casat M.D.; John Walkup M.D.; Sanjeev Pathak M.D.; Paul Rohde M.D.; Kelly Posner Ph.D.; John March M.D.
• Date Published: December 2006
• Length: 16 pages
• Contract Number(s): N01 MH80008
• Sponsoring Agency: National Institute of Mental Health
• Corporate Author: The TADS Team
• Publication Format: Article
• Publication Type: Program/Project Evaluation
• Language: English
• Country: United States of America
• Note: For other articles in this series, see NCJ-216589-93 and 216595.

Annotation

This study examined adverse physical, psychiatric, and suicide-related events experienced by adolescents with major depressive disorder while they were participating in 12 weeks of treatment in the Treatment for Adolescents With Depression Study (TADS); the 439 adolescents were randomly assigned to treatment with either fluoxetine (FLX), cognitive-behavioral therapy (CBT), both fluoxetine and CBT (COMB), or clinical management with pill placebo (PBO).

Abstract

Generally, as depression improved, physical complaints and suicidal ideation decreased in proportion to treatment benefit. Adverse psychiatric events and suicide-related events were more common in FLX-treated patients. COMB treatment apparently provided a more favorable safety profile than medication alone. The adolescents reported high rates of physical symptoms at entry, which improved as depression improved. Sedation, insomnia, vomiting, and upper abdominal pain occurred in at least 2 percent of those treated with FLX and/or COMB and at twice this rate for those in the PBO group. The rate of adverse psychiatric events was 11 percent in FLX, 5.6 percent in COMB, 4.5 percent in PBO, and 0.9 percent in CBT. Suicidal ideation improved overall, with the greatest improvement in COMB. Twenty-four suicide-related events occurred during the 12-week period; 10 in FLX, 5 in COMB, 5 in CBT, and 3 in PBO. Statistically, only FLX had more suicide-related events than PBO. Only five actual suicide attempts occurred (two in COMB, two in FLX, one in CBT, and none in PBO). There were no suicide completions. Information and data on adverse events were collected by spontaneous reports and systematic measures for specific physical and psychiatric symptoms. Suicidal ideation and suicidal behavior were systematically assessed by self-reports and clinician reports. Suicidal events were reanalyzed by the Columbia Group and expert raters by using the Columbia-Classification Algorithm for Suicidal Assessment used in the U.S. Food and Drug Administration reclassification effort. 5 tables, 1 figure, and 28 references