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

Istituto Auxologico Italiano

Status: Enrolling

Conditions: Anorexia Nervosa

Treatments: Drug: Citalopram p.o; Drug: Citalopram i.v. and p.o

Study type: Observational

Funder types: Other

Identifiers

NCT05795283

21C222

Details and patient eligibility

About

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).

Enrollment: 123 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

123 participants in 2 patient groups

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

Description:

Both intravenous and oral administration of citalopram

Treatment:

Drug: Citalopram i.v. and p.o

Group B: Citalopram p.o

Description:

Oral administration of citalopram

Treatment:

Drug: Citalopram p.o