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ABSTRACT: The analyses were conducted to identify possibly suicide-related adverse events in Pfizer-sponsored, phases 2 through 4, placebo-controlled, completed studies of sertraline in adult patients and evaluate the risk of suicidality with sertraline versus placebo.
U.S. Food and Drug Administration (FDA)-defined search methodology was used to identify possibly suicide-related adverse events in short-term, all-duration/all-indication, and psychiatric studies of sertraline. Categorization of possibly suicide-related adverse events was based on the approach developed by the Columbia group for the FDA's analysis of pediatric suicide risk with antidepressants. The incidences of possibly suicide-related adverse events were calculated for individual classifications and for the predefined combined category of suicidality along with the sertraline versus placebo relative risks and corresponding 95% CI limits. Exact binomial CI limits were calculated for the individual treatment group incidences. Age group analyses were also performed using the age limits defined by the FDA.
Ninety-nine suicidality events were identified among 19,923 sertraline- and placebo-treated subjects participating in 126 studies conducted between the mid-1980s and the mid-2000s. Four cases of completed suicides among 10,917 sertraline-treated subjects yielded an incidence of 0.04% (95% CI = 0.01 to 0.09) and 3 cases among 9,006 placebo treated subjects yielded an incidence of 0.03% (95% CI = 0.01 to 0.10). There were no statistically significant differences between sertraline and placebo in any of the individual categories or combined suicidality risk category across all performed analyses.
Results of short-term, all-duration, and psychiatric studies analyses, as well as age-group analyses, performed in accordance with the FDA-specified search strategy, show no significant increase in suicidality risk in adult sertraline- versus placebo-treated patients.
The Journal of Clinical Psychiatry 06/2009; 70(5):674-83. · 5.80 Impact Factor
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ABSTRACT: At the 2005 Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP), the Academy's Workgroup on Research conducted a Research Forum entitled "Increasing Research Literacy Through the Adoption of Evidence-Based Practice (EBP) in Pediatric Psychiatry."
Forum participants focused on speeding the adoption of EBP across five areas: EBP as the preferred heuristic for teaching research literacy, use of EBP in training programs, dissemination of EBP in clinical practice, EBP in partnership with industry, and EBP as a framework for developing practice guidelines.
EBP provides an easy-to-understand method for accessing and evaluating the research literature and then applying this information to decisions about patient care. Although EBP has been gaining greater visibility in pediatric psychiatry, it is far from the preferred heuristic. To move the field toward fully embracing EBP will require greater understanding of what EBP is (and is not), educating mental health professionals in EBP skills, access to EBP resources, and a commitment to apply EBP to the conceptualization and design of research protocols and practice guidelines.
Pediatric psychiatry would benefit from a principled commitment to follow other areas of medicine in adopting EBP.
Journal of the American Academy of Child & Adolescent Psychiatry 10/2007; 46(9):1098-110. · 6.44 Impact Factor
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ABSTRACT: The aim of this study was to examine the balance between the benefits of treatment and the risk of suicidality in children and adolescents in multicenter, randomized, controlled trials of sertraline versus placebo.
The published literature was searched for multicenter, randomized, placebo-controlled trials of sertraline for pediatric mental disorders. Four trials were identified: Two (pooled) in pediatric major depressive disorder (MDD; Wagner 2003) and two in obsessive-compulsive disorder (OCD; March et al. 1998; POTS Team 2004). Using intent-to-treat (ITT) analysis populations, the authors calculated the number needed to treat (NNT) for response and remission and the number needed to harm (NNH) for suicidality, and their ratio, for each clinical trial.
NNTs ranged from 2 to 10, indicating clinically meaningful benefits. Benefit was greater for OCD than for MDD, and for adolescents as compared with children in MDD. No age effect was apparent for OCD. Suicidality was reported in 8 patients (5 assigned to sertraline and 3 assigned to placebo). All but 1 (a placebo-treated patient in the Pfizer OCD trial) were enrolled in the sertraline MDD trial. The NNH for suicidality in MDD was 64. Treatment emergent suicidality was more common in children (NNH 28.7) than in adolescents (NNH 706.3). Because no patient developed suicidality in sertraline-treated OCD patients, the NNH for sertraline in OCD approaches infinity.
With the stipulation that doctor and patient preferences necessarily play a critical role in the choice of treatment, NNT to NNH ratios indicate a positive benefit-to-risk ratio for sertraline in adolescents with MDD and in patients of all ages with OCD.
Journal of Child and Adolescent Psychopharmacology 16(1-2):91-102. · 2.88 Impact Factor
