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

NCT05795283 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 123

Last updated 2023-04-03

No results posted yet for this study

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).

Conditions

  • Anorexia Nervosa

Interventions

DRUG

Citalopram i.v. and p.o

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

DRUG

Citalopram p.o

Citalopram: p.o: 10 mg/die for day 1-7, 20 mg/die for day 15-28

Sponsors & Collaborators

  • Istituto Auxologico Italiano

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2024-08-01
Completion
2024-08-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05795283 on ClinicalTrials.gov