Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05795283
Status:
RECRUITING
Last Update Posted:
2023-04-03
First Post:
2023-03-21
Brief Title:
Potential Predictive Biological Markers of Major Depression Response to Citalopram Therapy in Anorexia Nervosa
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
Potential Predictive Biological Markers of Major Depression Response to Citalopram Therapy in Patients With Anorexia Nervosa a Single-center Study
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANCITA
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 os and iv 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
The present observational study aims to evaluate the correlations between the clinical response to Citalopram therapy in different os and iv 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None