Selective serotonin reuptake inhibitors in pediatric depression: is the balance between benefits and risks favorable?

Recent controversies surrounding the use of selective serotonin reuptake inhibitors (SSRIs) have highlighted the need to reassess potential benefits, as well as potential risks of this class of medications in the treatment of pediatric depression. The recent availability of data from meta-analyses of published and unpublished antidepressant trials, epidemiological studies, and the Treatment for Adolescents with Depression Study (TADS) has facilitated a reanalysis of this risk/benefit relationship. Despite reviewing similar data, various regulatory agencies have arrived at rather disparate conclusions regarding the data, resulting in continued controversy. Although all groups appear to agree that careful assessment, education regarding risks, and closer monitoring are essential for SSRIs, only the U.S. Food and Drug Administration (FDA) and the U.K. Medicine and Health Care Products Regulatory Agency maintain that an acceptable risk/benefit relationship exists for fluoxetine. The European Medicines Agency concluded that the SSRIs should not be used in the treatment of depression in children and adolescents. The authors of this review have taken into consideration many of these same data and offer a critical discussion of the pros and cons of SSRIs in pediatric depression. The authors have concluded that SSRIs -- in particular, fluoxetine -- do have a role in the treatment of pediatric depression.

Outpatient treatment of child and adolescent depression in the United States.

BACKGROUND: Although psychotherapy has traditionally been the dominant form of treatment for children and adolescents with depression, there has been a recent increase in the prescription of antidepressants for this age group. OBJECTIVE: To describe patterns of outpatient treatment for children and adolescents with depression. DESIGN AND SETTING: Analysis of health service-use data from 4 consecutive years (1996-1999) of the Medical Expenditure Panel Survey, a nationally representative annual survey of the general population that is sponsored by the Agency for Healthcare Quality and Research, Rockville, Md. Subjects Patients aged 6 to 18 years who made 1 or more outpatient visits for the treatment of depression. MAIN OUTCOME MEASURES: Rate of treatment, mental health problems, psychotropic medication use, psychotherapy use, number of outpatient treatment visits, and type of provider. RESULTS: Across the 4 survey years, the mean annual rate of outpatient treatment for depression was 0.93 per 100 individuals. The rate of treatment was especially low for African American individuals (0.23 per 100) and uninsured individuals (0.43 per 100). Approximately three quarters (79%) of treated children and adolescents received psychotherapy and more than half (56.9%) were prescribed antidepressant medications. The mean number of treatment visits for depression was 7.8 per year. As compared with children and adolescents with depression who were treated without antidepressants, those who received antidepressants were significantly more likely to have evidence of anhedonia, to live in large urban communities, to have parents who graduated from high school, and to have health insurance. CONCLUSIONS: The rate and pattern of treatment suggest that serious gaps exist in access to community outpatient treatment for children and adolescents with depression. At the same time, antidepressant medications are used far more commonly than would be expected on the basis of published treatment recommendations.

Child/Adolescent Anxiety Multimodal Study (CAMS): rationale, design, and methods.

OBJECTIVE: To present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS), a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT), sertraline (SRT), and their combination (COMB) against pill placebo (PBO) for the treatment of separation anxiety disorder (SAD), generalized anxiety disorder (GAD) and social phobia (SoP) in children and adolescents. METHODS: Following a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described. RESULTS: CAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488) children and adolescents (ages 7-17 years) with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance. CONCLUSIONS: CAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT) and pharmacologic (SSRI) treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results of CAMS will hold important implications for informing practice-relevant decisions regarding the initial treatment of youth with anxiety disorders. TRIAL REGISTRATION: ClinicalTrials.gov NCT00052078.