DepressionNCT06496087
Evaluation of DEPREXIL in Patients With Clinical Depression Through Psychological and Neuroendocrine Assessment
A study testing DEPREXIL in people with Depression and Post-COVID-19 Syndrome, run by Catalysis SL at 1 site in Colombia.
Trial summary
Clinical depression is a mood disorder that affects people of all ages with symptoms such as sadness, anger or frustration, appetite changes, difficulty concentrating and suicidal thoughts. Psychological and pharmacological treatments are available to treat it, such as cognitive behavioral therapy and antidepressants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Post-COVID-19 Syndrome, Depression Mild
- What is being tested?
- DEPREXIL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteColombia
- Study dates
- 1 Nov 2022to 15 Apr 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical depression diagnosed primary or secondary to concomitant illness or post COVID-19.
Who cannot join
- Patients with psychological disorders in addition to depression, such as anxiety, attention deficit, hyperactivity disorder, post-traumatic stress disorder other than that caused by COVID-19, bipolar disorder or other mental disorders secondary to depression.
- Patients with severe depression requiring antidepressant medication.
- Patients who ingest psychoactive substances.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundación CR INVESTIGATION INSTITUTE
Bogotá, Bogotá DC, 110131
About this study
Official title: Evaluation of DEPREXIL Treatment in Patients With Clinical Depression Through Psychological and Neuroendocrine Assessment
Clinical depression is a mood disorder that affects people of all ages with symptoms such as sadness, anger or frustration, appetite changes, difficulty concentrating and suicidal thoughts. Psychological and pharmacological treatments are available to treat it, such as cognitive behavioral therapy and antidepressants. Deprexil® from Catalysis is a food supplement that regulates neuronal metabolism and calcium homeostasis, which may help in cases of mild to moderate depression. It is proposed to conduct a study in patients with primary, secondary or post-COVID-19 depression to evaluate the effects of this supplement on psychological and neuroendocrine changes.
Read the detailed description
Clinical depression is a mood disorder where feelings of sadness, anger or frustration interfere with daily life for a prolonged period of time. It can affect people of all ages, presenting symptoms such as irritable or low mood, difficulty falling asleep or oversleeping, change in appetite, fatigue, feelings of worthlessness, hatred and guilt, difficulty concentrating, and suicidal thoughts; however, in children these symptoms can vary, especially focusing on behavior, sleep, and school performance. Various treatments are available, ranging from psychological treatments, such as cognitive behavioral therapy or psychotherapy, to antidepressant medications, such as selective serotonin reuptake inhibitors, depending on the severity of the depression.
Deprexil® by Catalysis is a food supplement to treat mild and moderate depressive states. The molecular action process to which its active ingredients are subjected regulates neuronal metabolism as well as calcium homeostasis. A large number of diseases with an imbalance in calcium homeostasis have depressive effects on the Central Nervous System (CNS) and peripheral nervous system (PNS), and therefore, it is capable of regulating neuronal metabolism by stabilizing the neuronal membrane and favoring its oxygenation. Therefore, to evaluate the effects of Deprexil®, the investigators propose to conduct a study in patients diagnosed with primary depression or secondary to concomitant pathologies or post-COVID-19, treated with this dietary supplement, assessing psychological and neuroendocrine changes.
Each patient will undergo an initial evaluation by means of a psychological consultation, which will be carried out again 3 and 6 months after the beginning of the treatment. Likewise, the levels of hormones and neuropeptides such as GABA, Dopamine, Serotonin, Noradrenalin, Melatonin, Glutamate, Cortisol and dehydroepiandrosterone will be analyzed at the beginning and at the end of the treatment, which will consist in the intake of Deprexil® of Catalysis, in doses of three capsules daily during 6 months. Based on this, the correspondence with neuroendocrine alterations found in the patients will be evaluated according to the results of the psychological evaluation, seeking to evaluate the changes on the patient's symptomatology at clinical and paraclinical level, giving as results the analysis on the changes caused at neuroendocrine level secondary to COVID-19, to a concomitant pathology or to a primary depressive pathology.
- Being tested
- DEPREXIL
- Keywords
- Depression, Antioxidant, Supportive Care, Post-COVID-19 Syndrome, Ginkgo Biloba
- Medical subject headings
- Depression, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEPREXILDietary supplement
The trial group will be administered 1 capsule of DEPREXIL orally every 8 hours for 6 months of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Deprexil Group | Experimental | The trial group will be administered 1 capsule of DEPREXIL orally every 8 hours for 6 months of treatment. Receives: Dietary Supplement: DEPREXIL |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the psychological state of depressive patients treated with Deprexil® by patient questionnaire test
To evaluate the psychological state of depressive patients treated with Deprexil® by Zung test of patients with a depressive state assessment tool using a Google Forms questionnaire, automatically tabulating the answers for analysis. Evaluation before, after 3 months and 6 months of treatment with Deprexil.
Each item of the Zung scale can provide a score between 1 and 4; the range of values is therefore 20-80 points.
- Less than 28 points = No depression.
- between 28 and 41 points = Mild depression.
- between 42 and 53 points = Moderate depression.
- 53 or more points = Severe depression.
Measured: 6 months
To evaluate the psychological state of depressive patients treated with Deprexil® by hormonal levels
To evaluate the psychological state of depressive patients treated with Deprexil®. To evaluate the concentration of hormones by means of NeuroSpot Kit in depressive patients before and after 6 months of treatment with Deprexil®. Kit will measure Serotonin, Creatinine, Dopamine, Noradrenaline, Adrenaline.
Urine sample:
- Second morning urine: The next urine over the course of the morning after getting up and after the first morning urine (Going to the toilet during the night does not count in this content)
Saliva samples:
- 1st Sample 0,5 hours after getting up
- 2nd Sample at 12:00 noon
- 3rd Sample at 8:00 PM
Serotonin(55-129 ug/g creatinine) Dopamine (125-250 ug/g creatinine) Noradrenaline (25-55 ug/g creatinine) Adrenaline (3.0-7.0 ug/g creatinine)
Measured: 6 months
To evaluate the psychological state of depressive patients treated with Deprexil® by hormonal levels
To evaluate the psychological state of depressive patients treated with Deprexil®. To evaluate the concentration of hormones by means of NeuroSpot Kit in depressive patients before and after 6 months of treatment with Deprexil®. Kit will measure Cortisol (morning, noon, evening).
Urine sample:
- Second morning urine: The next urine over the course of the morning after getting up and after the first morning urine (Going to the toilet during the night does not count in this content)
Saliva samples:
- 1st Sample 0,5 hours after getting up
- 2nd Sample at 12:00 noon
- 3rd Sample at 8:00 PM
Cortisol (4.0-12; 1.5-5 ng/ml)
Measured: 6 months
To evaluate the psychological state of depressive patients treated with Deprexil® by hormonal levels
To evaluate the psychological state of depressive patients treated with Deprexil®. To evaluate the concentration of hormones by means of NeuroSpot Kit in depressive patients before and after 6 months of treatment with Deprexil®. Kit will measure DHEA (morning, evening).
Urine sample:
- Second morning urine: The next urine over the course of the morning after getting up and after the first morning urine (Going to the toilet during the night does not count in this content)
Saliva samples:
- 1st Sample 0,5 hours after getting up
- 2nd Sample at 12:00 noon
- 3rd Sample at 8:00 PM
DHEA (104-578; 45-251 pg/ml)
Measured: 6 months
To evaluate the psychological state of depressive patients treated with Deprexil® by neuropeptides
To evaluate the psychological state of depressive patients treated with Deprexil®. To evaluate the concentration of neuropeptides by means of NeuroSpot Kit in depressive patients before and after 6 months of treatment with Deprexil®. Kit will measure GABA and Glutamate levels.
Urine sample:
- Second morning urine: The next urine over the course of the morning after getting up and after the first morning urine (Going to the toilet during the night does not count in this content).
Saliva samples:
- 1st Sample 0,5 hours after getting up
- 2nd Sample at 12:00 noon
- 3rd Sample at 8:00 PM
GABA (2.25-12.8 umol/ g creatinine) Glutamate (8.0-30 umol/ g creatinine)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Nov 2022
- Primary completion15 Dec 2023
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496087
- Sponsor's protocol ID
- DEPREXIL_DEPRESSION_CO_2022
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Mazza MG, De Lorenzo R, Conte C, Poletti S, Vai B, Bollettini I, Melloni EMT, Furlan R, Ciceri F, Rovere-Querini P; COVID-19 BioB Outpatient Clinic Study group; Benedetti F. Anxiety and depression in COVID-19 survivors: Role of inflammatory and clinical predictors. Brain Behav Immun. 2020 Oct;89:594-600. doi: 10.1016/j.bbi.2020.07.037. Epub 2020 Jul 30.
PubMed 32738287Perez-Cano HJ, Moreno-Murguia MB, Morales-Lopez O, Crow-Buchanan O, English JA, Lozano-Alcazar J, Somilleda-Ventura SA. Anxiety, depression, and stress in response to the coronavirus disease-19 pandemic. Cir Cir. 2020;88(5):562-568. doi: 10.24875/CIRU.20000561.
PubMed 33064695Li Y, Scherer N, Felix L, Kuper H. Prevalence of depression, anxiety and post-traumatic stress disorder in health care workers during the COVID-19 pandemic: A systematic review and meta-analysis. PLoS One. 2021 Mar 10;16(3):e0246454. doi: 10.1371/journal.pone.0246454. eCollection 2021.
PubMed 33690641Mazza MG, Palladini M, Poletti S, Benedetti F. Post-COVID-19 Depressive Symptoms: Epidemiology, Pathophysiology, and Pharmacological Treatment. CNS Drugs. 2022 Jul;36(7):681-702. doi: 10.1007/s40263-022-00931-3. Epub 2022 Jun 21.
PubMed 35727534
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of DEPREXIL Treatment in Patients With Clinical Depression Through Psychological and Neuroendocrine Assessment
- ClinicalTrials.gov ID
- NCT06496087
- Acronym / sponsor ID
- DEPREXIL_DEPRESSION_CO_2022
- Keywords
- Depression, Antioxidant, Supportive Care, Post-COVID-19 Syndrome, Ginkgo Biloba
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 11 Jul 2024 (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.
Clinical depression is a mood disorder that affects people of all ages with symptoms such as sadness, anger or frustration, appetite changes, difficulty concentrating and suicidal thoughts. Psychological and pharmacological treatments are available to treat it, such as cognitive behavioral therapy and antidepressants. Deprexil® from Catalysis is a food supplement that regulates neuronal metabolism and calcium homeostasis, which may help in cases of mild to moderate depression. It is proposed to conduct a study in patients with primary, secondary or post-COVID-19 depression to evaluate the effects of this supplement on psychological and neuroendocrine changes.
Detailed description
Clinical depression is a mood disorder where feelings of sadness, anger or frustration interfere with daily life for a prolonged period of time. It can affect people of all ages, presenting symptoms such as irritable or low mood, difficulty falling asleep or oversleeping, change in appetite, fatigue, feelings of worthlessness, hatred and guilt, difficulty concentrating, and suicidal thoughts; however, in children these symptoms can vary, especially focusing on behavior, sleep, and school performance. Various treatments are available, ranging from psychological treatments, such as cognitive behavioral therapy or psychotherapy, to antidepressant medications, such as selective serotonin reuptake inhibitors, depending on the severity of the depression.
Deprexil® by Catalysis is a food supplement to treat mild and moderate depressive states. The molecular action process to which its active ingredients are subjected regulates neuronal metabolism as well as calcium homeostasis. A large number of diseases with an imbalance in calcium homeostasis have depressive effects on the Central Nervous System (CNS) and peripheral nervous system (PNS), and therefore, it is capable of regulating neuronal metabolism by stabilizing the neuronal membrane and favoring its oxygenation. Therefore, to evaluate the effects of Deprexil®, the investigators propose to conduct a study in patients diagnosed with primary depression or secondary to concomitant pathologies or post-COVID-19, treated with this dietary supplement, assessing psychological and neuroendocrine changes.
Each patient will undergo an initial evaluation by means of a psychological consultation, which will be carried out again 3 and 6 months after the beginning of the treatment. Likewise, the levels of hormones and neuropeptides such as GABA, Dopamine, Serotonin, Noradrenalin, Melatonin, Glutamate, Cortisol and dehydroepiandrosterone will be analyzed at the beginning and at the end of the treatment, which will consist in the intake of Deprexil® of Catalysis, in doses of three capsules daily during 6 months. Based on this, the correspondence with neuroendocrine alterations found in the patients will be evaluated according to the results of the psychological evaluation, seeking to evaluate the changes on the patient's symptomatology at clinical and paraclinical level, giving as results the analysis on the changes caused at neuroendocrine level secondary to COVID-19, to a concomitant pathology or to a primary depressive pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deprexil Group | Experimental | Dietary Supplement: DEPREXILThe trial group will be administered 1 capsule of DEPREXIL orally every 8 hours for 6 months of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with clinical depression diagnosed primary or secondary to concomitant illness or post COVID-19.
Key exclusion criteria (3 listed)
- Patients with psychological disorders in addition to depression, such as anxiety, attention deficit, hyperactivity disorder, post-traumatic stress disorder other than that caused by COVID-19, bipolar disorder or other mental disorders secondary to depression.
- Patients with severe depression requiring antidepressant medication.
- Patients who ingest psychoactive substances.
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 |
|---|---|---|
| DEPREXILThe trial group will be administered 1 capsule of DEPREXIL orally every 8 hours for 6 months of treatment. | Dietary supplement | Deprexil Group |
Primary outcome
To evaluate the psychological state of depressive patients treated with Deprexil® by patient questionnaire test
Time frame: 6 months
To evaluate the psychological state of depressive patients treated with Deprexil® by Zung test of patients with a depressive state assessment tool using a Google Forms questionnaire, automatically tabulating the answers for analysis. Evaluation before, after 3 months and 6 months of treatment with Deprexil. Each item of the Zung scale can provide a score between 1 and 4; the range of values is therefore 20-80 points. 1. Less than 28 points = No depression. 2. between 28 and 41 points = Mild depression. 3. between 42 and 53 points = Moderate depression. 4. 53 or more points = Severe depression.
To evaluate the psychological state of depressive patients treated with Deprexil® by hormonal levels
Time frame: 6 months
To evaluate the psychological state of depressive patients treated with Deprexil®. To evaluate the concentration of hormones by means of NeuroSpot Kit in depressive patients before and after 6 months of treatment with Deprexil®. Kit will measure Serotonin, Creatinine, Dopamine, Noradrenaline, Adrenaline. Urine sample: • Second morning urine: The next urine over the course of the morning after getting up and after the first morning urine (Going to the toilet during the night does not count in this content) Saliva samples: * 1st Sample 0,5 hours after getting up * 2nd Sample at 12:00 noon * 3rd Sample at 8:00 PM Serotonin(55-129 ug/g creatinine) Dopamine (125-250 ug/g creatinine) Noradrenaline (25-55 ug/g creatinine) Adrenaline (3.0-7.0 ug/g creatinine)
To evaluate the psychological state of depressive patients treated with Deprexil® by hormonal levels
Time frame: 6 months
To evaluate the psychological state of depressive patients treated with Deprexil®. To evaluate the concentration of hormones by means of NeuroSpot Kit in depressive patients before and after 6 months of treatment with Deprexil®. Kit will measure Cortisol (morning, noon, evening). Urine sample: • Second morning urine: The next urine over the course of the morning after getting up and after the first morning urine (Going to the toilet during the night does not count in this content) Saliva samples: * 1st Sample 0,5 hours after getting up * 2nd Sample at 12:00 noon * 3rd Sample at 8:00 PM Cortisol (4.0-12; 1.5-5 ng/ml)
To evaluate the psychological state of depressive patients treated with Deprexil® by hormonal levels
Time frame: 6 months
To evaluate the psychological state of depressive patients treated with Deprexil®. To evaluate the concentration of hormones by means of NeuroSpot Kit in depressive patients before and after 6 months of treatment with Deprexil®. Kit will measure DHEA (morning, evening). Urine sample: • Second morning urine: The next urine over the course of the morning after getting up and after the first morning urine (Going to the toilet during the night does not count in this content) Saliva samples: * 1st Sample 0,5 hours after getting up * 2nd Sample at 12:00 noon * 3rd Sample at 8:00 PM DHEA (104-578; 45-251 pg/ml)
To evaluate the psychological state of depressive patients treated with Deprexil® by neuropeptides
Time frame: 6 months
To evaluate the psychological state of depressive patients treated with Deprexil®. To evaluate the concentration of neuropeptides by means of NeuroSpot Kit in depressive patients before and after 6 months of treatment with Deprexil®. Kit will measure GABA and Glutamate levels. Urine sample: • Second morning urine: The next urine over the course of the morning after getting up and after the first morning urine (Going to the toilet during the night does not count in this content). Saliva samples: * 1st Sample 0,5 hours after getting up * 2nd Sample at 12:00 noon * 3rd Sample at 8:00 PM GABA (2.25-12.8 umol/ g creatinine) Glutamate (8.0-30 umol/ g creatinine)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Background: PubMed 32738287Mazza MG, De Lorenzo R, Conte C, Poletti S, Vai B, Bollettini I, Melloni EMT, Furlan R, Ciceri F, Rovere-Querini P; COVID-19 BioB Outpatient Clinic Study group; Benedetti F. Anxiety and depression in COVID-19 survivors: Role of inflammatory and clinical predictors. Brain Behav Immun. 2020 Oct;89:594-600. doi: 10.1016/j.bbi.2020.07.037. Epub 2020 Jul 30.
- Background: PubMed 33064695Perez-Cano HJ, Moreno-Murguia MB, Morales-Lopez O, Crow-Buchanan O, English JA, Lozano-Alcazar J, Somilleda-Ventura SA. Anxiety, depression, and stress in response to the coronavirus disease-19 pandemic. Cir Cir. 2020;88(5):562-568. doi: 10.24875/CIRU.20000561.
- Background: PubMed 33690641Li Y, Scherer N, Felix L, Kuper H. Prevalence of depression, anxiety and post-traumatic stress disorder in health care workers during the COVID-19 pandemic: A systematic review and meta-analysis. PLoS One. 2021 Mar 10;16(3):e0246454. doi: 10.1371/journal.pone.0246454. eCollection 2021.
- Background: PubMed 35727534Mazza MG, Palladini M, Poletti S, Benedetti F. Post-COVID-19 Depressive Symptoms: Epidemiology, Pathophysiology, and Pharmacological Treatment. CNS Drugs. 2022 Jul;36(7):681-702. doi: 10.1007/s40263-022-00931-3. Epub 2022 Jun 21.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEPREXIL in people with Depression and Post-COVID-19 Syndrome, run by Catalysis SL at 1 site in Colombia.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 11 Jul 2024. 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 Colombia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the psychological state of depressive patients treated with Deprexil® by patient questionnaire test (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06496087, which also lists 4 linked publications.
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 11 Jul 2024.