A prospective randomized double blind placebo controlled crossover study of fluoxetine efficacy in the prophylaxis of chronic daily headache in children and adolescents

Gherpelli, José Luiz Dias; Esposito, Sandro Blasi

doi:10.1590/s0004-282x2005000400001

Cited by 9 publications

(3 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This is similar to findings from another US‐based trial investigating fluoxetine safety and efficacy in children and adolescents with OCD which found that a significantly greater number of fluoxetine‐treated subjects reported weight loss than those receiving placebo . Interestingly, two other randomized controlled trials that did not report weight change found that gastrointestinal side effects (such as nausea and diarrhoea) were reported as adverse events within the fluoxetine‐treated groups .…”

Section: Resultssupporting

confidence: 82%

The effect of antidepressants and antipsychotics on weight gain in children and adolescents

et al. 2015

View full text Add to dashboard Cite

Psychiatric illness in the paediatric population is increasing and the weight effect of medications for these problems is often unclear. A comprehensive literature search was undertaken to identify studies reporting weight in relation to antipsychotic and antidepressant use in children and adolescents. From 636 articles, 42 were selected for review. Selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) do not cause weight gain and may lead to improvements in weight status over the short, but not, long term. Antipsychotics were generally associated with weight gain. In drug comparison studies, risperidone had a larger weight gain effect than lithium, divalproex sodium and pimozide. Studies assessing the weight-protective effects of augmentation therapy with metformin or topiramate show less weight gain with addition of these agents. In conclusion, prescribing of SSRIs and SNRIs may be associated with improvements in weight status in children and adolescents but trials assessing their use in obesity, outside of established psychiatric illness, are limited and still experimental. Youth prescribed antipsychotic medication should be monitored for exaggerated weight gain and in those where obesity is a pre-existing concern agents other than olanzapine, clozapine and risperidone may be advantageous.

show abstract

Section: Resultssupporting

confidence: 82%

The effect of antidepressants and antipsychotics on weight gain in children and adolescents

et al. 2015

View full text Add to dashboard Cite

show abstract

“…Example explanations included: (1) disappointment of allocation to the control group, 26 and (2) the methodology used, including long treatment periods and complicated study visit schedules (n=2). 2,19 3.4. Fulfillment of CONSORT harms reporting recommendations.…”

Section: Reportingmentioning

confidence: 99%

Design and Reporting Characteristics of Clinical Trials of Select Chronic and Recurrent Pediatric Pain Conditions: An Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks Systematic Review

Connolly

Chaudari

Yang

et al. 2019

The Journal of Pain

View full text Add to dashboard Cite

Fewer randomized clinical trials (RCTs) are conducted for chronic or recurrent pain in pediatric populations compared with adult populations; thus, data to support treatment efficacy in children are limited. This article evaluates the design features and reporting practices of RCTs for chronic and recurrent pain that are likely unique to, or particularly important in, a pediatric population to promote improvements in the evidence base for pediatric pain treatments. Areas covered include outcome measure selection and reporting and reporting of adverse events and challenges to recruitment and retention. A search of PubMed and EMBASE identified primary publications describing RCTs of treatments for select chronic and recurrent pain conditions in children or adolescents published between 2000 and 2017. Only 49% of articles identified a primary outcome measure. The primary outcome measure assessed pain intensity in 38% of the trials, specifically measure by verbal rating scale (13%), faces pain scale (11%), visual analogue scale (9%), or numeric rating scale (5%). All of the CONSORT harms reporting recommendations were fulfilled by <50% of the articles. Discussions of recruitment challenges occurred in 64% of articles that enrolled <90% of their target sample. However, discussions regarding retention challenges only occurred in 14% of trials in which withdrawal rates were >10%. The goal of this article is to promote comprehensive reporting of pediatric pain RCTs to improve the design of future trials, facilitate conduction of systematic reviews and meta-analyses, and better inform clinical practice. PERSPECTIVE: This review of chronic and recurrent pediatric pain trials demonstrates inadequacies in the reporting quality of key features specifically important to pediatric populations. It provides recommendations that address these shortcomings to promote continued efforts toward improving the quality of the design and publication of future pediatric clinical pain trials.

show abstract

“…In a small, randomized, double-blind, placebo-controlled trial, fluoxetine was not superior to placebo for CDH [73]. Selective serotonin-reuptake inhibitors may be considered [79] when CDH is complicated by anxiety or mood disorders [60••].…”

Section: Pharmacological Treatmentmentioning

confidence: 99%

Chronic Daily Headache in Children and Adolescents

Seshia

2011

Curr Pain Headache Rep

View full text Add to dashboard Cite

Chronic daily headache (CDH) may be primary or secondary. Secondary causes can be suspected through "red flags" in the history and examination. With a prevalence of at least 1% and several associations, primary CDH is a common, often complex, chronic pain syndrome in children and adolescents. The intricate associations between stressors, psychiatric disorders (especially anxiety and depression), and CDH can be explained by "the limbically augmented pain syndrome" proposed by Rome and Rome. Disorders of sleep and other pain syndromes also may co-occur. For these reasons, a multiaxial classification is ideal. Many with primary CDH have features of both chronic migraine and chronic tension-type headache, contributing to confusion in subtyping. Primary CDH is often transformed from a primary episodic headache type, stressors being most responsible. Genetic factors also may facilitate chronification. Management should be biopsychosocial, family-centered, and often multidisciplinary, drugs being only one component. Treatment is still based on consensus, not evidence. Girls, migraineurs, and those with psychiatric comorbidity, medication overuse, and CDH onset before the age of 13 years and lasting for 2 years or longer, are at high risk for persistence; hence, such patients should be followed up into adult life. A classification for CDH should be included in the third edition of the International Classification of Headache Disorders.

show abstract

A prospective randomized double blind placebo controlled crossover study of fluoxetine efficacy in the prophylaxis of chronic daily headache in children and adolescents

Cited by 9 publications

References 12 publications

The effect of antidepressants and antipsychotics on weight gain in children and adolescents

The effect of antidepressants and antipsychotics on weight gain in children and adolescents

Design and Reporting Characteristics of Clinical Trials of Select Chronic and Recurrent Pediatric Pain Conditions: An Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks Systematic Review

Chronic Daily Headache in Children and Adolescents

Contact Info

Product

Resources

About