Potential Predictive Biological Markers of Major Depression Response to Citalopram Therapy in Anorexia Nervosa.

Study Overview
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Brief Summary
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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).

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

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Drug: Citalopram i.v. and p.o
* Drug: Citalopram p.o


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anorexia nervosa Severe depression (Hamilton score 25 or higher) Written informed consent Exclusion Criteria: Other psychiatric disorders Acute infectious diseases Chronic inflammatory diseases Disorders of central nervous system Pregnancy ore breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A: Citalopram i.v. and p.o<br>Both intravenous and oral administration of citalopram | Drug: Citalopram i.v. and p.o<br>* Citalopram: i.v.: 10 mg/die for day 1-7, 20 mg/die for day 8-14 p.o.: 20 mg/die for day 15-28<br>|
| Group B: Citalopram p.o<br>Oral administration of citalopram | Drug: Citalopram p.o<br>* Citalopram: p.o: 10 mg/die for day 1-7, 20 mg/die for day 15-28<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hamilton Depression Rating Scale | 17-item Hamilton Depression Rating Scale - | At baseline, 2 weeks and 4 weeks after treatment with citalopram | 
| Change in plasma level of citalopram | Plasma level of citalopram | At baseline, 2 weeks and 4 weeks after treatment with citalopram | 
| Change in plasma level of dopamine | Plasma level of dopamine | At baseline, 2 weeks and 4 weeks after treatment with citalopram | 
| Change in serum level of serotonin | Serum level of serotonin | At baseline, 2 weeks and 4 weeks after treatment with citalopram | 
| Change in serum level of brain-derived neurotrophic factor | Serum level of brain-derived neurotrophic factor | At baseline, 2 weeks and 4 weeks after treatment with citalopram | 
| Change in serum level of tryptophan | Serum level of tryptophan | At baseline, 2 weeks and 4 weeks after treatment with citalopram | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major depression, Citalopram, Biological markers