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

NCT ID: NCT05795283

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 123 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-08-01

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).

Conditions

Anorexia Nervosa

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Both intravenous and oral administration of citalopram

Citalopram i.v. and p.o

Intervention Type: DRUG

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

Citalopram p.o

Intervention Type: DRUG

Citalopram:

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

Interventions

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

Intervention Type: DRUG

Citalopram p.o

Citalopram:

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Auxologico Italiano

Oggebbio, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Riccardo Cremascoli, MD

Role: CONTACT

r.cremascoli@auxologico.it

+393497292068

Facility Contacts

Riccardo Cremascoli, MD

Role: primary

Other Identifiers

21C222

Identifier Type: -

Identifier Source: org_study_id