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

NCT05795283 | Unknown

• 1 other identifier: 21C222
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

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

Keywords

Major depression; Citalopram; Biological markers

Outcome Measures

Primary Outcomes (6)

• Change in Hamilton Depression Rating Scale

  17-item Hamilton Depression Rating Scale -

  At baseline, 2 weeks and 4 weeks after treatment with citalopram

• Change in plasma level of citalopram

  Plasma level of citalopram

  At baseline, 2 weeks and 4 weeks after treatment with citalopram

• Change in plasma level of dopamine

  Plasma level of dopamine

  At baseline, 2 weeks and 4 weeks after treatment with citalopram

• Change in serum level of serotonin

  Serum level of serotonin

  At baseline, 2 weeks and 4 weeks after treatment with citalopram

• 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

• Change in serum level of tryptophan

  Serum level of tryptophan

  At baseline, 2 weeks and 4 weeks after treatment with citalopram

Study Arms (2)

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

Both intravenous and oral administration of citalopram

Drug: Citalopram i.v. and p.o

Group B: Citalopram p.o

Oral administration of citalopram

Drug: Citalopram p.o

Interventions

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

Citalopram p.o DRUG

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

Group B: Citalopram p.o

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with anorexia nervosa and severe depression

You may qualify if:

• Anorexia nervosa
• Severe depression (Hamilton score 25 or higher)
• Written informed consent

You may not qualify if:

• Other psychiatric disorders
• Acute infectious diseases
• Chronic inflammatory diseases
• Disorders of central nervous system
• Pregnancy ore breastfeeding

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano

Oggebbio, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Anorexia Nervosa; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Central Study Contacts

Riccardo Cremascoli, MD

CONTACT

+393497292068; r.cremascoli@auxologico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 3, 2023
• Study Start: August 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

IT (1)