Article

The Treatment for Adolescents with Depression Study (TADS) - Long-term effectiveness and safety outcomes

University of Texas at Austin, Austin, Texas, United States
Archives of General Psychiatry (Impact Factor: 13.75). 11/2007; 64(10):1132-43. DOI: 10.1001/archpsyc.64.10.1132
Source: PubMed

ABSTRACT The Treatment for Adolescents With Depression Study evaluates the effectiveness of fluoxetine hydrochloride therapy, cognitive behavior therapy (CBT), and their combination in adolescents with major depressive disorder.
To report effectiveness outcomes across 36 weeks of randomized treatment.
Randomized, controlled trial conducted in 13 academic and community sites in the United States. Cognitive behavior and combination therapies were not masked, whereas administration of placebo and fluoxetine was double-blind through 12 weeks, after which treatments were unblinded. Patients assigned to placebo were treated openly after week 12, and the placebo group is not included in these analyses by design.
Three hundred twenty-seven patients aged 12 to 17 years with a primary DSM-IV diagnosis of major depressive disorder.
All treatments were administered per protocol.
The primary dependent measures rated blind to treatment status by an independent evaluator were the Children's Depression Rating Scale-Revised total score and the response rate, defined as a Clinical Global Impressions-Improvement score of much or very much improved.
Intention-to-treat analyses on the Children's Depression Rating Scale-Revised identified a significant time x treatment interaction (P < .001). Rates of response were 73% for combination therapy, 62% for fluoxetine therapy, and 48% for CBT at week 12; 85% for combination therapy, 69% for fluoxetine therapy, and 65% for CBT at week 18; and 86% for combination therapy, 81% for fluoxetine therapy, and 81% for CBT at week 36. Suicidal ideation decreased with treatment, but less so with fluoxetine therapy than with combination therapy or CBT. Suicidal events were more common in patients receiving fluoxetine therapy (14.7%) than combination therapy (8.4%) or CBT (6.3%).
In adolescents with moderate to severe depression, treatment with fluoxetine alone or in combination with CBT accelerates the response. Adding CBT to medication enhances the safety of medication. Taking benefits and harms into account, combined treatment appears superior to either monotherapy as a treatment for major depression in adolescents.

0 Followers
 · 
157 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: Mental health problems in children and adolescents are frequent, with a high risk of persistence into adulthood. Therefore, the investigation of determinants of onset and course of mental health problems is of high importance. The present paper investigates the impact of protective and risk factors on the development of depressive symptoms in children and adolescents. The BELLA study is the mental health module of the German National Health Interview and Examination Survey for children and adolescents (KIGGS). Based on the first three measurement points of the BELLA study (covering a period of 2 years), the present analysis focused on children and adolescents aged 11-17 years at baseline (n = 1,643; 50.6 % female). A longitudinal growth modelling approach was used. Mental health problems in parents (parent-reports) predicted depressive symptoms in children and adolescents (self-reports) as well as the development of these symptoms over time. Further, child-reported protective factors of self-efficacy, positive family climate and social support were associated with less depressive symptoms at baseline. Additionally, positive changes in protective factors were associated with the development of less depressive symptoms over time. Finally, family climate and social support moderated the detrimental influence of parental psychopathology on child's depressive symptoms. The addressed determinants for the development of depressive symptoms in children and adolescents are highly relevant for prevention and intervention strategies. Future research should investigate specific risk and protective factors focusing in detail on further mental health disorders and their development in children and adolescents.
    European Child & Adolescent Psychiatry 11/2014; DOI:10.1007/s00787-014-0637-5 · 3.55 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: This study compared the acute phase (12-week) and the long-term (1 year) efficacy of fluoxetine versus placebo for the treatment of the depressive symptoms and the cannabis use of youth with comorbid major depressive disorder (MDD) and an cannabis use disorder (CUD)(cannabis dependence or cannabis abuse). We hypothesized that fluoxetine would demonstrate efficacy in the acute phase trial and at the 1-year follow-up evaluation. Data is also provided regarding the prevalence of risky sexual behaviors in our study sample.
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Fluoxetine is the only psychopharmacological agent approved for depression by the US Food and Drug Administration for children and is commonly used therapeutically in a variety of neurodevelopmental disorders. Therapeutic response shows high individual variability, and severe side effects have been observed. In the current study we set out to identify biomarkers of response to fluoxetine as well as biomarkers that correlate with impulsivity, a measure of reward delay behavior and potential side effect of the drug, in juvenile male rhesus monkeys. The study group was also genotyped for polymorphisms of monoamine oxidase A (MAOA), a gene that has been associated with psychiatric disorders. We used peripheral metabolite profiling of blood and cerebrospinal fluid (CSF) from animals treated daily with fluoxetine or vehicle for one year. Fluoxetine response metabolite profiles and metabolite/reward delay behavior associations were evaluated using multivariate analysis. Our analyses identified a set of plasma and CSF metabolites that distinguish fluoxetine- from vehicle-treated animals and metabolites that correlate with impulsivity. Some metabolites displayed an interaction between fluoxetine and MAOA genotype. The identified metabolite biomarkers belong to pathways that have important functions in central nervous system physiology. Biomarkers of response to fluoxetine in the normally functioning brain of juvenile nonhuman primates may aid in finding predictors of response to treatment in young psychiatric populations and in progress toward the realization of a precision medicine approach in the area of neurodevelopmental disorders.
    Translational Psychiatry 11/2014; 4:e478. DOI:10.1038/tp.2014.116 · 4.36 Impact Factor

Full-text (2 Sources)

Download
48 Downloads
Available from
May 31, 2014