2006
DOI: 10.1089/cap.2006.16.131
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The Relevance of Pharmacokinetic Studies in Designing Efficacy Trials in Juvenile Major Depression

Abstract: Medication dosing regimens may have contributed to the failure of several RPCTs to show drug efficacy in the treatment of pediatric MDD. In addition, the doses of medication used in these RPCTs may also have contributed to the safety and tolerability concerns that have been raised with these drugs. PK and dose-ranging studies should be performed prior to the initiation of definitive efficacy trials so that empirically supported dosing strategies can be incorporated into the design of RPCTs of antidepressants i… Show more

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Cited by 61 publications
(38 citation statements)
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“…Even less is known about pharmacokinetic response in other minority groups (Sramek and Pi 1996). However, as noted in a recent review of the literature (Findling et al 2006), even the existing information is being underutilized. Most randomized, placebo-controlled trials to date do not utilize the dosing strategies suggested by pharmacokinetic data.…”
Section: S Department Of Health and Human Services 2001; Freedenthanmentioning
confidence: 99%
“…Even less is known about pharmacokinetic response in other minority groups (Sramek and Pi 1996). However, as noted in a recent review of the literature (Findling et al 2006), even the existing information is being underutilized. Most randomized, placebo-controlled trials to date do not utilize the dosing strategies suggested by pharmacokinetic data.…”
Section: S Department Of Health and Human Services 2001; Freedenthanmentioning
confidence: 99%
“…[91] Dosages have ranged from 0.24 mg kg day in a 5-year-old [90] to 15-45 mg day in children 7 years of age and older. [92] Commonly reported adverse effects attributed to mirtazapine included tiredness, dizziness, and increased appetite. Antidepressant use in children and adolescents has been associated with an increased risk of suicidal behaviour or ideation, although the benefit risk ratio of these agents is controversial.…”
Section: Mirtazapinementioning
confidence: 99%
“…However, fluoxetine trials showed equal efficacy in children and in adolescents [26]. The superiority of fluoxetine over other agents in the treatment of prepubertal depression may be explained by the pharmacokinetic properties of paroxetine, sertraline, citalopram, and venlafaxine [86]. For most SSRIs, the half-life in children is much lower than it is in adolescents [86,87], yet the dosing recommendations parallel those for adults.…”
Section: Predictors Of Treatment Outcomementioning
confidence: 99%
“…The superiority of fluoxetine over other agents in the treatment of prepubertal depression may be explained by the pharmacokinetic properties of paroxetine, sertraline, citalopram, and venlafaxine [86]. For most SSRIs, the half-life in children is much lower than it is in adolescents [86,87], yet the dosing recommendations parallel those for adults. There is some evidence that inadequate exposure to antidepressants can lead to a lower response rate and --conversely --that increasing exposure by increasing the dose of antidepressant can improve the response rate [88].…”
Section: Predictors Of Treatment Outcomementioning
confidence: 99%