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