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

Recruiting

• Conditions: Anorexia Nervosa
• Interventions: Drug: Citalopram i.v. and p.o; Drug: Citalopram p.o

• Registration Number: NCT05795283
• Lead Sponsor: Istituto Auxologico Italiano

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-21
• Study First Submitted QC: 2023-03-21
• Last Update Submitted: 2023-03-21
• Study First Posted: 2023-04-03
• Last Update Posted: 2023-04-03
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A: Citalopram i.v. and p.o	Citalopram i.v. and p.o	Both intravenous and oral administration of citalopram
Group B: Citalopram p.o	Citalopram p.o	Oral administration of citalopram

Primary Outcome Measures

Name	Time	Method
Change in Hamilton Depression Rating Scale	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	At baseline, 2 weeks and 4 weeks after treatment with citalopram	Serum level of brain-derived neurotrophic factor
Change in serum level of serotonin	At baseline, 2 weeks and 4 weeks after treatment with citalopram	Serum level of serotonin
Change in plasma level of dopamine	At baseline, 2 weeks and 4 weeks after treatment with citalopram	Plasma level of dopamine
Change in serum level of tryptophan	At baseline, 2 weeks and 4 weeks after treatment with citalopram	Serum level of tryptophan
Change in plasma level of citalopram	At baseline, 2 weeks and 4 weeks after treatment with citalopram	Plasma level of citalopram

Trial Locations

Locations (1)

Istituto Auxologico Italiano; 🇮🇹 Oggebbio, Italy