Therapeutic Drug Monitoring (TDM) in Child & Adolescent Psychiatry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Blood level concentrations of the drugs in use;
研究概览
简要总结
The investigators aim to analyse in adolescents with mental illness effectiveness, side effects, and serum level concentrations of antipsychotics (olanzapine and aripiprazole), antidepressants (Duloxetine, Atomoxetine) by means of "Therapeutic Drug Monitoring" (TDM) in order to optimize dosage - effect relations and minimize unwanted side effects.
详细描述
We aim to analyse in adolescents with mental illness effectiveness, side effects, and serum level concentrations of antipsychotics (olanzapine and aripiprazole), antidepressants (Duloxetine, Atomoxetine) by means of "Therapeutic Drug Monitoring" (TDM) in order to optimize dosage - effect relations and minimize unwanted side effects.
Therapeutic drug monitoring is becoming a quality measure in psychopharmacotherapy in adults and children and has been used successfully recently (Hiemke 2008). In 2007, the German Child & Adolescent Psychiatry University Clinics have founded a network the "TDM-network" headed by Profs. C. Mehler-Wex and J. Fegert in Ulm (www.tdm-kjp-de). The Viennese Child and Adolescent Clinic is part of this network. Most importantly, this network must and wants to be independent from the pharmaceutical industry in order to get un-biased scientific results and data. Within this network, which has been successfully established in the participating clinical departments it is possible to take the lead in several scientific areas.
Highest ethical standards, data-protection and rigorous designs are needed to protect childrens' and adolescents' rights.
Therapeutic drug monitoring (TDM) and its implication for treatment and research: By definition, TDM signifies the dosage of a drug by controlling its concentration in serum. It aims at establishing the therapeutical range of the drug given and thus at minimizing the risk of over- or undermedication (Pschyrembel 2002). Indications for therapeutic drug monitoring in general comprise the following aspects: - Poor response to the administered drug despite a clinically established dosage - Severe side effects despite a clinically established dosage - Combining medications which bear potential to interact adversely with each other - Treatment of patients at risk (immunosuppression, patients in intensive care, patients at need of longterm treatment, patients with a high level of comorbidity or genetic abberations, patients at risk of non-compliance)- Questionable adherence to the treatment regime -Child and adolescent populations
The scientific background of TDM refers to the assumption that the serum concentration of substances along with their active metabolites represent a better measure of their concentration in the brain as the actual dose (Laux & Riederer, 1992; Baumann et al., 2004). Additionally, it is stated that there is a defined relation between serum concentration and clinical effect. This correlation could be confirmed e.g. for the tricyclic antidepressants imipramine und desipramine (Baumann et al., 2004).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 19 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •appropriate diagnosis and severity of the disorder of interest
- •age range 10-19
排除标准
- •below 10 yrs of age
- •no written informed consent possible due to intelligence or no willingness by parents to include minor
研究组 & 干预措施
Anorexia nervosa
36 severe AN patients treated with aripiprazole
干预措施: Aripiprazole (Drug)
Anorexia
36 severe anorexia nervosa patients treated with olanzapine
干预措施: Olanzapine (Drug)
Anorexia
36 severe anorexia nervosa patients treated with olanzapine
干预措施: Aripiprazole (Drug)
Attention Deficit Hyperactivity Disorder
30 ADHD patients treated with atomoxetine
干预措施: Atomoxetine (Drug)
Depressive disorder
30 depressed patients treated with duloxetine
干预措施: Duloxetine (Drug)
结局指标
主要结局
Blood level concentrations of the drugs in use;
时间窗: 5 weeks
Blood level concentration of the druns in use
次要结局
- Level of symtomatology(5 weeks)
研究者
Dr. Andreas Karwautz
Univ. Prof. Dr.
Medical University of Vienna
