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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Drug: Citalopram i.v. and p.o; Drug: Citalopram p.o

• Study Type: Observational
• Enrollment (Anticipated): 123

Contacts and Locations

• Study Contact: Name: Riccardo Cremascoli, MD; Phone Number: +393497292068; Email: r.cremascoli@auxologico.it

Study Locations

• Italy
  • Oggebbio, Italy
    • Recruiting
    • Istituto Auxologico Italiano
    • Contact: Riccardo Cremascoli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with anorexia nervosa and severe depression

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Major depression; Biological markers; Citalopram
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Depressive Disorder; Depression; Anorexia; Anorexia Nervosa; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Antiparkinson Agents; Anti-Dyskinesia Agents; Citalopram; Dexetimide
• Other Study ID Numbers: 21C222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No