Efficacy of Sertraline in the Treatment of Children and Adolescents With Major Depressive Disorder&lt;SUBTITLE&gt;Two Randomized Controlled Trials&lt;/SUBTITLE&gt;

Wagner, Karen Dineen; Ambrosini, Paul J.; Rynn, Moira A.; Wohlberg, Christopher J.; Yang, Ruoyong; Greenbaum, Michael; Childress, Ann; Donnelly, Craig L.; Deas, Deborah

doi:10.1001/jama.290.8.1033

Cited by 369 publications

(222 citation statements)

References 35 publications

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“…This sample size calculation assumed a pooled standard deviation (SD) of 9 and a two sided test at an overall experiment type I error rate of 0.050, consistent with the published literature reporting controlled trials in adolescents with depression (Wagner et al 2003;March et al 2004;Wagner et al 2004).…”

Section: Statistical Analysesmentioning

confidence: 66%

Efficacy and Safety of Extended-Release Quetiapine Fumarate in Youth with Bipolar Depression: An 8 Week, Double-Blind, Placebo-Controlled Trial

Findling

Pathak

Earley³

et al. 2014

Journal of Child and Adolescent Psychopharmacology

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Objective: Quetiapine is an atypical antipsychotic with demonstrated efficacy in the treatment of adolescent schizophrenia and pediatric bipolar mania. Large, placebo-controlled studies of interventions in pediatric bipolar depression are lacking. The current study investigated the efficacy and safety of quetiapine extended-release (XR) in patients 10-17 years of age, with acute bipolar depression. Methods: This multicenter, double-blind, randomized, placebo-controlled study investigated quetiapine XR (dose range, 150-300 mg/day) in pediatric outpatients with an American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR) diagnosis of bipolar I or bipolar II disorder (current or most recent episode depressed) treated for up to 8 weeks (ClinicalTrials.gov identifier: NCT00811473). The primary study outcome was mean change in Children's Depression Rating Scale-Revised (CDRS-R) total score. Secondary efficacy outcomes included CDRS-R-based response and remission rates. Results: Of 193 patients randomized to treatment, 144 patients completed the study (75.3% of quetiapine XR group [n = 70]; 74.0% of placebo group [n = 74]). Least squares mean changes in CDRS-R total score at week 8 were: -29.6 (SE, 1.65) with quetiapine XR and -27.3 (SE, 1.60) with placebo, a between-treatment group difference of -2.29 (SE, 1.99; 95% CI, -6.22, 1.65; p = 0.25; mixed-model for repeated measures analysis). Rates of response and remission did not differ significantly between treatment groups. The safety profile of quetiapine XR was broadly consistent with the profile reported previously in adult studies of quetiapine XR and pediatric studies of quetiapine immediate-release (IR). Potentially clinically significant elevations in clinical chemistry values included triglycerides (9.3%, quetiapine XR; 1.4%, placebo group) and thyroid stimulating hormone (4.7%, quetiapine XR; 0%, placebo group). An adverse event potentially related to diabetes mellitus occurred in 3.3% of the quetiapine XR versus no adverse events in the placebo group. Conclusions: Quetiapine XR did not demonstrate efficacy relative to placebo in this 8 week study of pediatric bipolar depression. Quetiapine XR was generally safe and well tolerated.

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Section: Statistical Analysesmentioning

confidence: 66%

Efficacy and Safety of Extended-Release Quetiapine Fumarate in Youth with Bipolar Depression: An 8 Week, Double-Blind, Placebo-Controlled Trial

Findling

Pathak

Earley³

et al. 2014

Journal of Child and Adolescent Psychopharmacology

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“…Wagner and others have performed the most recent published controlled trial of SSRIs in child and adolescent MDD (17). Sponsored by Pfizer, this investigation originally comprised 2 separate controlled trials.…”

Section: Resultsmentioning

confidence: 99%

Selective Serotonin Reuptake Inhibitor and Venlafaxine Use in Children and Adolescents with Major Depressive Disorder: A Systematic Review of Published Randomized Controlled Trials

Courtney

2004

Can J Psychiatry

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Objective: This review critiques published randomized placebo-controlled trials pertaining to the efficacy and safety of selective serotonin reuptake inhibitors (SSRIs) and venlafaxine in the treatment of major depressive disorder in children and adolescents. Method:Medline was searched for articles meeting defined inclusion criteria. The following key terms were used: depressive disorders, antidepressive agents, fluoxetine, paroxetine, sertraline, citalopram, fluvoxamine, venlafaxine, child, and adolescent.Results: Six articles met inclusion criteria. Only 2 studies claim efficacy by significant results in primary outcomes; both have since been contested in further analysis. Not one study adequately examines safety, particularly with respect to whether a link exists between antidepressant use and induction of suicidal ideation or attempts. Conclusion:Published studies on SSRI or venlafaxine use in children and adolescents are inconclusive with respect to safety and efficacy, owing to inappropriate claims of efficacy, lack of improvement in global functioning scores, nonstandardized data collection regarding adverse effects, exclusion of suicidal subjects in the recruitment process, grouping of children and adolescents together, small sample sizes, conflict of interest posed by pharmaceutical company sponsorship, and publishing bias. Future investigators should consider these factors when developing study designs. (Can J Psychiatry 2004;49:557-563) Information on author affiliations appears at the end of the article. Clinical Implications· Published evidence regarding the efficacy of selective serotonin reuptake inhibitor (SSRI) and venlafaxine use in children and adolescents with major depression is inconclusive. · Published evidence regarding the safety of SSRI and venlafaxine use in children and adolescents with major depression is also inconclusive. · For future studies of this issue to be clinically relevant, researchers should base claims of efficacy on primary outcomes, should adequately measure suicidal ideation and behaviours, and should have nonindustry funding. Limitations· Unpublished studies were not included in the review.

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“…These were both negative. They were reported in combined form, however, as showing that Zoloft was effective and well tolerated (Wagner et al 2003). In fact, 59 percent of children on Zoloft showed a change of five points on a Clinical Global Impression scale, against 49 percent of children on placebo showing comparable changes, a finding that only reaches statistical significance when both studies are combined.…”

Section: Zoloftmentioning

confidence: 99%

Manufacturing Consensus

Healy

2006

Cult Med Psychiatry

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ABSTRACT. The Food and Drug Administration (FDA) has declared that it would be illegal to advertise as or in any way claim your drug to be superior to competitors on the market, which are up to 30 times cheaper. How does a pharmaceutical company market such a product? The answer is to enlist academics to form expert panels to construct guidelines and algorithms, or participate in Delphi panels and other exercises, which can be expected to prove that newer, more costly drugs produce cost savings. These academics do so on the basis of the existing clinical trial evidence-which supposedly the FDA has used to come to its verdict that the newer compound is no better than its competitors. However, where the FDA has seen the raw data, academics later see the published data. In between intervenes a medical writing exercise, which produces the first and most important piece of advertising for any pharmaceutical product-the randomized controlled trial infomercial. This paper explores how pharmaceutical companies manufacture an apparent academic consensus and, in so doing, gives a case study of the recent controversies surrounding the marketing of selective serotonin reuptake inhibitor (SSRI) drugs for adolescent depression.

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Efficacy of Sertraline in the Treatment of Children and Adolescents With Major Depressive Disorder<SUBTITLE>Two Randomized Controlled Trials</SUBTITLE>

Cited by 369 publications

References 35 publications

Efficacy and Safety of Extended-Release Quetiapine Fumarate in Youth with Bipolar Depression: An 8 Week, Double-Blind, Placebo-Controlled Trial

Efficacy and Safety of Extended-Release Quetiapine Fumarate in Youth with Bipolar Depression: An 8 Week, Double-Blind, Placebo-Controlled Trial

Selective Serotonin Reuptake Inhibitor and Venlafaxine Use in Children and Adolescents with Major Depressive Disorder: A Systematic Review of Published Randomized Controlled Trials

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