PMID- 17135989
OWN - NLM
STAT- MEDLINE
DCOM- 20061228
LR  - 20231106
IS  - 0890-8567 (Print)
IS  - 1527-5418 (Electronic)
IS  - 0890-8567 (Linking)
VI  - 45
IP  - 12
DP  - 2006 Dec
TI  - Treatment for Adolescents with Depression Study (TADS): safety results.
PG  - 1440-55
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.
FAU - Emslie, Graham
AU  - Emslie G
AD  - UT Southwestern Medical Centre at Dallas, TX 75390-8589, USA. 
      emslie@utsouthwestern.edu
FAU - Kratochvil, Christopher
AU  - Kratochvil C
FAU - Vitiello, Benedetto
AU  - Vitiello B
FAU - Silva, Susan
AU  - Silva S
FAU - Mayes, Taryn
AU  - Mayes T
FAU - McNulty, Steven
AU  - McNulty S
FAU - Weller, Elizabeth
AU  - Weller E
FAU - Waslick, Bruce
AU  - Waslick B
FAU - Casat, Charles
AU  - Casat C
FAU - Walkup, John
AU  - Walkup J
FAU - Pathak, Sanjeev
AU  - Pathak S
FAU - Rohde, Paul
AU  - Rohde P
FAU - Posner, Kelly
AU  - Posner K
FAU - March, John
AU  - March J
CN  - Columbia Suicidality Classification Group
CN  - TADS Team
LA  - eng
GR  - N01 MH080008/MH/NIMH NIH HHS/United States
GR  - N01MH80008/MH/NIMH NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PL  - United States
TA  - J Am Acad Child Adolesc Psychiatry
JT  - Journal of the American Academy of Child and Adolescent Psychiatry
JID - 8704565
RN  - 01K63SUP8D (Fluoxetine)
SB  - IM
CIN - J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1456-60. PMID: 17135990
CIN - J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1461-4. PMID: 17135991
CIN - Evid Based Ment Health. 2007 Aug;10(3):85. PMID: 17652567
MH  - Adolescent
MH  - Algorithms
MH  - Child
MH  - Cognitive Behavioral Therapy/*methods
MH  - Combined Modality Therapy
MH  - Depressive Disorder, Major/diagnosis/drug therapy/*therapy
MH  - Diagnostic and Statistical Manual of Mental Disorders
MH  - Double-Blind Method
MH  - Female
MH  - Fluoxetine/*therapeutic use
MH  - Humans
MH  - Life Change Events
MH  - Male
MH  - Suicide, Attempted/psychology/statistics & numerical data
MH  - Surveys and Questionnaires
PMC - PMC3285253
MID - NIHMS347905
EDAT- 2006/12/01 09:00
MHDA- 2006/12/29 09:00
PMCR- 2012/02/23
CRDT- 2006/12/01 09:00
PHST- 2006/12/01 09:00 [pubmed]
PHST- 2006/12/29 09:00 [medline]
PHST- 2006/12/01 09:00 [entrez]
PHST- 2012/02/23 00:00 [pmc-release]
AID - S0890-8567(09)61801-3 [pii]
AID - 10.1097/01.chi.0000240840.63737.1d [doi]
PST - ppublish
SO  - J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1440-55. doi: 
      10.1097/01.chi.0000240840.63737.1d.