Journal of the American Academy of Child & Adolescent Psychiatry
SPECIAL SECTION: TREATMENT FOR ADOLESCENTS WITH DEPRESSION STUDY-TADSTreatment for Adolescents With Depression Study (TADS): Safety Results
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Placebo-controlled, randomized clinical trials (RCTs) are the gold standard for evaluating efficacy and are also of critical importance in assessing safety and tolerability (March et al., 2004). Although they provide substantial information on the measurement of safety,
METHOD
The rationale, design, methods, and sample characteristics have been described in prior reports (TADS, 2003, TADS, 2005) and are included in the Special Section introduction by March et al. The patients were adolescents (N = 439), ages 12 to 17 years (mean ± SD, 14.6 ± 1.5 years), who were outpatients, with a primary DSM-IV diagnosis of MDD. The baseline mean Children's Depression Rating Scale-Revised (CDRS-R) total score was 60.1, and 86% of the sample were in their first episode of MDD.
Patient Disposition
TADS treatments proved acceptable and tolerable. Of the 439 randomized patients, 359 (81.8%) remained in their assigned treatment arm through 12 weeks of acute treatment, although eight of these missed the week 12 assessment visit. The proportion of patients who remained in the assigned treatment arm was greater with fluoxetine-treated patients. Specifically, 86.0% in COMB, 83.5% in FLX, 78.4% in CBT, and 79.5% in PBO were in their assigned treatment arm at the week 12 assessment point. There
DISCUSSION
The TADS was the first study to compare efficacy and safety of FLX, CBT, their combination, and placebo in the treatment of pediatric depression. The study is also among a relatively small number of trials that used systematic assessment of AEs, as well as the general inquiry used in most clinical trials. Over 80% of the adolescents completed 12 weeks of treatment in their assigned treatment arm, indicating the TADS treatments were generally acceptable and tolerable.
Depressed adolescents had
REFERENCES (28)
- et al.
Utah youth suicide study, phase I: government agency contact before death
J Am Acad Child Adolesc Psychiatry
(2002) - et al.
Review of safety assessment methods used in pediatric psychopharmacology
J Am Acad Child Adolesc Psychiatry
(2003) - et al.
Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial
J Am Acad Child Adolesc Psychiatry
(2001) - et al.
How can we improve the assessment of safety in child and adolescent psychopharmacology?
J Am Acad Child Adolesc Psychiatry
(2003) - et al.
A double-blind, randomized, placebo-controlled study of fluoxetine in depressed children and adolescents
Arch Gen Psychiatry
(1997) - et al.
Fluoxetine for acute treatment of depression in children and adolescents: a placebo-controlled, randomized clinical trial
J Am Acad Child and Adolesc Psychiatry
(2002) - et al.
The relationship between antidepressant medication use and rate of suicide
Arch Gen Psychiatry
(2005) - et al.
Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology
J Am Acad Child Adolesc Psychiatry
(2004) - et al.
Suicidality in pediatric patients treated with antidepressant drugs
Arch Gen Psychiatry
(2006) - et al.
Selective serotonin reuptake inhibitor antidepressants and the risk of suicide: a controlled forensic database study of 14 857 suicides
Acta Psychiatr Scand
(2005)
Statistical considerations for multiplicity in confirmatory protocols
Drug Information J
Paroxetine, other antidepressants, and youth suicide in New York City: 1993 through 1998
J Clin Psychiatry
Cross-Sectional and Prospective Relationships between Physical Morbidity and Depression in Older Adolescents
J Am Acad Child Adolesc Psychiatry
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See end of text for author affiliations.
The Columbia Suicidality Classification Group is led by Kelly Posner, Ph.D., Maria Oquendo, M.D., Madelyn Gould, Ph.D., M.P.H., and Barbara Stanley, Ph.D.
TADS is supported by contract N01 MH80008 from the National Institute of Mental Health to Duke University Medical Center (John S. March, Principal Investigator).
The authors thank and acknowledge the independent expert raters from the Columbia Suicidality Classification Project: David Brent, M.D., Greg Brown, Ph.D., David Rudd, Ph.D., Cheryl King, Ph.D., Anthony Spirito, Ph.D., A.B.P.P., Peter Marzuk, M.D., Patrick O'Carroll, M.D., M.P.H., Annette Beautrais, Ph.D., Kees Van Heeringen, M.D., Ph.D., and Alec Miller, Psy.D.
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Disclosure: Dr. Emslie receives research support from Eli Lilly, Organon, and Forest Laboratories; is a consultant for Eli Lilly, GlaxoSmithKline, Forest Laboratories, Wyeth-Ayerst, and Pfizer; and is on the speakers' bureau of McNeil. Dr. Kratochvil is a consultant or scientific advisor to Eli Lilly, Shire, Cephalon, Organon, AstraZeneca, Boehringer-Ingelheim, Abbott and Pfizer; receives research support from Eli Lilly, McNeil, Cephalon, and Abbott; receives study drug for an NIMH-funded study from Lilly; and is on the Eli Lilly speakers' bureau. Dr. Silva is a consultant to Pfizer. Dr. Weller is a consultant to and receives grants from Otsuka, Johnson & Johnson, AstraZeneca, Organon, Pharma, Shire, and GlaxoSmithKline. Dr. Waslick receives research support from Eli Lilly. Dr. Casat receives research support from Eli Lilly, GlaxoSmithKline, Shire, Bristol-Myers Squibb, AstraZeneca, Sanofi-Synthelabo, Pfizer, and McNeil; is on the Advisory Board and the speakers' bureaus of Eli Lilly and GlaxoSmithKline. Dr. Walkup receives research support from Eli Lilly, Pfizer, and Abbott; is a consultant to Eli Lilly, Pfizer, Jazz, and Cephalon; and has received honoraria from Eli Lilly and Pfizer. Dr. Pathak receives research support from Forest. Dr. Posner has received research support from GlaxoSmithKline, Forest, Eisai, AstraZeneca, Johnson & Johnson, Abbott, Wyeth, Organon, Bristol-Myers Squibb, Sanofi-Aventis, Cephalon, Novartis, Shire, and UCB Pharma. Dr. March is on the speakers' bureaus of Pfizer and Eli Lilly and has received research support from Eli Lilly, Pfizer, and Wyeth. The other authors have no financial relationships to disclose.