Treatment for Adolescents with Depression Study (TADS)

Safety results

Graham Emslie*, Christopher Kratochvil, Benedetto Vitiello, Susan Silva, Taryn Mayes, Steven McNulty, Elizabeth Weller, Bruce Waslick, Charles Casat, John Walkup, Sanjeev Pathak, Paul Rohde, Kelly Posner, John March, Maria Oquendo, Madelyn Gould, Barbara Stanley

*Corresponding author for this work

Research output: Contribution to journalArticle

119 Citations (Scopus)

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 =.0402, odds ratio (OR) = 3.7, 95% CI 1.00-63.7). 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. Copyright 2006

Original languageEnglish (US)
Pages (from-to)1440-1455
Number of pages16
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume45
Issue number12
DOIs
StatePublished - Dec 1 2006

Fingerprint

Fluoxetine
Depression
Safety
Suicide
Placebos
Cognitive Therapy
Suicidal Ideation
Psychiatry
Therapeutics
Sleep Initiation and Maintenance Disorders
United States Food and Drug Administration
Self Report
Abdominal Pain
Vomiting
Odds Ratio

Keywords

  • Adverse events
  • Cognitive-behavioral therapy
  • Fluoxetine
  • Major depressive disorder

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Psychiatry and Mental health

Cite this

Emslie, G., Kratochvil, C., Vitiello, B., Silva, S., Mayes, T., McNulty, S., ... Stanley, B. (2006). Treatment for Adolescents with Depression Study (TADS): Safety results. Journal of the American Academy of Child and Adolescent Psychiatry, 45(12), 1440-1455. https://doi.org/10.1097/01.chi.0000240840.63737.1d
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 ; Oquendo, Maria ; Gould, Madelyn ; Stanley, Barbara. / Treatment for Adolescents with Depression Study (TADS) : Safety results. In: Journal of the American Academy of Child and Adolescent Psychiatry. 2006 ; Vol. 45, No. 12. pp. 1440-1455.
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Emslie, G, Kratochvil, C, Vitiello, B, Silva, S, Mayes, T, McNulty, S, Weller, E, Waslick, B, Casat, C, Walkup, J, Pathak, S, Rohde, P, Posner, K, March, J, Oquendo, M, Gould, M & Stanley, B 2006, 'Treatment for Adolescents with Depression Study (TADS): Safety results', Journal of the American Academy of Child and Adolescent Psychiatry, vol. 45, no. 12, pp. 1440-1455. https://doi.org/10.1097/01.chi.0000240840.63737.1d

Treatment for Adolescents with Depression Study (TADS) : Safety results. / 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; Oquendo, Maria; Gould, Madelyn; Stanley, Barbara.

In: Journal of the American Academy of Child and Adolescent Psychiatry, Vol. 45, No. 12, 01.12.2006, p. 1440-1455.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Treatment for Adolescents with Depression Study (TADS)

T2 - Safety results

AU - Emslie, Graham

AU - Kratochvil, Christopher

AU - Vitiello, Benedetto

AU - Silva, Susan

AU - Mayes, Taryn

AU - McNulty, Steven

AU - Weller, Elizabeth

AU - Waslick, Bruce

AU - Casat, Charles

AU - Walkup, John

AU - Pathak, Sanjeev

AU - Rohde, Paul

AU - Posner, Kelly

AU - March, John

AU - Oquendo, Maria

AU - Gould, Madelyn

AU - Stanley, Barbara

PY - 2006/12/1

Y1 - 2006/12/1

N2 - 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% CI 1.00-63.7). 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. Copyright 2006

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% CI 1.00-63.7). 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. Copyright 2006

KW - Adverse events

KW - Cognitive-behavioral therapy

KW - Fluoxetine

KW - Major depressive disorder

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