跳至主要内容
临床试验/NCT05795283
NCT05795283招募中不适用

Potential Predictive Biological Markers of Major Depression Response to Citalopram Therapy in Patients With Anorexia Nervosa: a Single-center Study.

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2022年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
123
试验地点
1
主要终点
Change in Hamilton Depression Rating Scale

研究概览

简要总结

In patients suffering from anorexia nervosa associated with severe major depression, serotonin reuptake inhibitor drugs have shown little efficacy in significantly reducing depressive symptoms. A possible explanation for this poor efficacy could be that people with anorexia nervosa have a deficiency in amino acids such as tryptophan, which is necessary for the production of the neurotransmitter serotonin. Therefore, tryptophan supplementation has been suggested as a means of increasing the pharmacological response to serotonin reuptake inhibitor drugs in patients with anorexia nervosa. Furthermore, malnutrition present in patients suffering from anorexia nervosa is in some cases associated with problems of intestinal absorption of nutrients, with possible implications on the pharmacokinetics of the drugs administered, including selective serotonin reuptake inhibitors (SSRIs).

The present observational study aims to evaluate the correlations between the clinical response to Citalopram therapy (in different o.s. and i.v. formulations) and some nutritional, neurotransmitter and inflammatory biomarkers, in order to identify potential predictive markers of response to therapy for severe major depression in patients with anorexia nervosa.

The following parameters will be evaluated in patients enrolled in all 3 observation times described above:

  • Plasma concentration of Citalopram
  • Serum concentration of Serotonin
  • Plasma concentration of dopamine
  • Serum concentration of Tryptophan
  • Serum concentration of BDNF
  • Hamilton scale 17 items and other clinical scales (EDI-3, SCL-90, BUT).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Anorexia nervosa
  • Severe depression (Hamilton score 25 or higher)
  • Written informed consent

排除标准

  • Other psychiatric disorders
  • Acute infectious diseases
  • Chronic inflammatory diseases
  • Disorders of central nervous system
  • Pregnancy ore breastfeeding

研究组 & 干预措施

Group A: Citalopram i.v. and p.o

Both intravenous and oral administration of citalopram

干预措施: Citalopram i.v. and p.o (Drug)

Group B: Citalopram p.o

Oral administration of citalopram

干预措施: Citalopram p.o (Drug)

结局指标

主要结局

Change in Hamilton Depression Rating Scale

时间窗: At baseline, 2 weeks and 4 weeks after treatment with citalopram

17-item Hamilton Depression Rating Scale -

Change in serum level of brain-derived neurotrophic factor

时间窗: At baseline, 2 weeks and 4 weeks after treatment with citalopram

Serum level of brain-derived neurotrophic factor

Change in serum level of serotonin

时间窗: At baseline, 2 weeks and 4 weeks after treatment with citalopram

Serum level of serotonin

Change in plasma level of citalopram

时间窗: At baseline, 2 weeks and 4 weeks after treatment with citalopram

Plasma level of citalopram

Change in plasma level of dopamine

时间窗: At baseline, 2 weeks and 4 weeks after treatment with citalopram

Plasma level of dopamine

Change in serum level of tryptophan

时间窗: At baseline, 2 weeks and 4 weeks after treatment with citalopram

Serum level of tryptophan

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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