Clinical trial NCT05795283: Potential Predictive Biological Markers of Major Depression Response to Citalopram Therapy in Anorexia Nervosa.
Official title: Potential Predictive Biological Markers of Major Depression Response to Citalopram Therapy in Patients With Anorexia Nervosa: a Single-center Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anorexia Nervosa
Keywords: Major depression
Citalopram
Biological markers
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with anorexia nervosa and severe depression

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale
timeFrame: At baseline, 2 weeks and 4 weeks after treatment with citalopram
measure: Change in plasma level of citalopram
timeFrame: At baseline, 2 weeks and 4 weeks after treatment with citalopram
measure: Change in plasma level of dopamine
timeFrame: At baseline, 2 weeks and 4 weeks after treatment with citalopram
measure: Change in serum level of serotonin
timeFrame: At baseline, 2 weeks and 4 weeks after treatment with citalopram
measure: Change in serum level of brain-derived neurotrophic factor
timeFrame: At baseline, 2 weeks and 4 weeks after treatment with citalopram
measure: Change in serum level of tryptophan
timeFrame: At baseline, 2 weeks and 4 weeks after treatment with citalopram
Secondary outcomes:
Other outcomes:
Locations:
city: Oggebbio
country: Italy
facility: Istituto Auxologico Italiano
Study officials:
References: