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

Sponsor

Istituto Auxologico Italiano (Other)

Overall Status

Recruiting

CT.gov ID

NCT05795283

Collaborator

(none)

123

Enrollment

Location

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa	Drug: Citalopram i.v. and p.o Drug: Citalopram p.o

Study Design

Study Type:

Observational

Anticipated Enrollment :

123 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Group A: Citalopram i.v. and p.o

Both intravenous and oral administration of citalopram

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

Group B: Citalopram p.o

Oral administration of citalopram

Drug: Citalopram p.o

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

Outcome Measures

Primary Outcome Measures

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 plasma level of citalopram [At baseline, 2 weeks and 4 weeks after treatment with citalopram]
Plasma level of citalopram
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 serotonin [At baseline, 2 weeks and 4 weeks after treatment with citalopram]
Serum level of serotonin
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 tryptophan [At baseline, 2 weeks and 4 weeks after treatment with citalopram]
Serum level of tryptophan