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

Anorexia Nervosa Clinical Trial

— ANCITA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05795283
• Other study ID #: 21C222
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: Riccardo Cremascoli, MD
• Phone: +393497292068
• Email: r.cremascoli[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 123
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Depression
• Depressive Disorder, Major

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano	Oggebbio

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hamilton Depression Rating Scale	17-item Hamilton Depression Rating Scale -	At baseline, 2 weeks and 4 weeks after treatment with citalopram
Primary	Change in plasma level of citalopram	Plasma level of citalopram	At baseline, 2 weeks and 4 weeks after treatment with citalopram
Primary	Change in plasma level of dopamine	Plasma level of dopamine	At baseline, 2 weeks and 4 weeks after treatment with citalopram
Primary	Change in serum level of serotonin	Serum level of serotonin	At baseline, 2 weeks and 4 weeks after treatment with citalopram
Primary	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
Primary	Change in serum level of tryptophan	Serum level of tryptophan	At baseline, 2 weeks and 4 weeks after treatment with citalopram