Anorexia NervosaANCITANCT05795283
Potential Predictive Biological Markers of Major Depression Response to Citalopram Therapy in Anorexia Nervosa.
An observational study of Anorexia Nervosa, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Citalopram i.v. and p.o and Citalopram p.o
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 123 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2022to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with anorexia nervosa and severe depression
Who may be able to join
- Anorexia nervosa
- Severe depression (Hamilton score 25 or higher)
- Written informed consent
Who cannot join
- Other psychiatric disorders
- Acute infectious diseases
- Chronic inflammatory diseases
- Disorders of central nervous system
- Pregnancy ore breastfeeding
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano
Oggebbio
Riccardo Cremascoli, MD
About this study
Official title: 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.
Read more
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
- Being tested
- Citalopram i.v. and p.o, Citalopram p.o
- Keywords
- Major depression, Citalopram, Biological markers
- Medical subject headings
- Anorexia Nervosa, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citalopram i.v. and p.oDrug
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
Citalopram p.oDrug
Citalopram:
p.o: 10 mg/die for day 1-7, 20 mg/die for day 15-28
| Study group | Role | What they receive |
|---|---|---|
| Group A: Citalopram i.v. and p.o | Both intravenous and oral administration of citalopram Receives: Drug: Citalopram i.v. and p.o | |
| Group B: Citalopram p.o | Oral administration of citalopram Receives: Drug: Citalopram p.o |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale
17-item Hamilton Depression Rating Scale -
Measured: At baseline, 2 weeks and 4 weeks after treatment with citalopram
Change in plasma level of citalopram
Plasma level of citalopram
Measured: At baseline, 2 weeks and 4 weeks after treatment with citalopram
Change in plasma level of dopamine
Plasma level of dopamine
Measured: At baseline, 2 weeks and 4 weeks after treatment with citalopram
Change in serum level of serotonin
Serum level of serotonin
Measured: 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
Measured: At baseline, 2 weeks and 4 weeks after treatment with citalopram
Change in serum level of tryptophan
Serum level of tryptophan
Measured: At baseline, 2 weeks and 4 weeks after treatment with citalopram
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Aug 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795283
- Sponsor's protocol ID
- 21C222
- Acronym
- ANCITA
- Status last verified
- Mar 2023
- First submitted
- 21 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Predictive Biological Markers of Major Depression Response to Citalopram Therapy in Patients With Anorexia Nervosa: a Single-center Study.
- ClinicalTrials.gov ID
- NCT05795283
- Acronym / sponsor ID
- ANCITA / 21C222
- Conditions
- Anorexia Nervosa
- Keywords
- Major depression, Citalopram, Biological markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Citalopram i.v. and p.o | – | Drug: Citalopram i.v. and p.oBoth intravenous and oral administration of citalopram |
| Group B: Citalopram p.o | – | Drug: Citalopram p.oOral administration of citalopram |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with anorexia nervosa and severe depression
Key inclusion criteria (3 listed)
- Anorexia nervosa
- Severe depression (Hamilton score 25 or higher)
- Written informed consent
Key exclusion criteria (5 listed)
- Other psychiatric disorders
- Acute infectious diseases
- Chronic inflammatory diseases
- Disorders of central nervous system
- Pregnancy ore breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citalopram i.v. and p.oCitalopram: 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 | Drug | Group A: Citalopram i.v. and p.o |
| Citalopram p.oCitalopram: p.o: 10 mg/die for day 1-7, 20 mg/die for day 15-28 | Drug | Group B: Citalopram p.o |
Primary outcome
Change in Hamilton Depression Rating Scale
Time frame: At baseline, 2 weeks and 4 weeks after treatment with citalopram
17-item Hamilton Depression Rating Scale -
Change in plasma level of citalopram
Time frame: At baseline, 2 weeks and 4 weeks after treatment with citalopram
Plasma level of citalopram
Change in plasma level of dopamine
Time frame: At baseline, 2 weeks and 4 weeks after treatment with citalopram
Plasma level of dopamine
Change in serum level of serotonin
Time frame: At baseline, 2 weeks and 4 weeks after treatment with citalopram
Serum level of serotonin
Change in serum level of brain-derived neurotrophic factor
Time frame: At baseline, 2 weeks and 4 weeks after treatment with citalopram
Serum level of brain-derived neurotrophic factor
Change in serum level of tryptophan
Time frame: At baseline, 2 weeks and 4 weeks after treatment with citalopram
Serum level of tryptophan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Riccardo Cremascoli, MD (+393497292068, r.cremascoli@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale (time frame: At baseline, 2 weeks and 4 weeks after treatment with citalopram). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.