Anorexia Nervosa
Conditions
Keywords
Major depression, Citalopram, Biological markers
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).
Interventions
DRUGCitalopram 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
DRUGCitalopram p.o
Citalopram: p.o: 10 mg/die for day 1-7, 20 mg/die for day 15-28
Sponsors
Istituto Auxologico Italiano
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactRiccardo Cremascoli, MD
Outcome results
None listed