Evaluation of DEPREXIL in Patients With Clinical Depression Through Psychological and Neuroendocrine Assessment
NCT Number: NCT06496087
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression|Post-COVID-19 Syndrome|Depression Mild|Depression Moderate
Interventions: DIETARY_SUPPLEMENT: DEPREXIL
Sponsor: Catalysis SL
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-11-01
Completion Date: 2024-04-15
Locations: Fundación CR INVESTIGATION INSTITUTE, Bogotá, Bogotá DC, 110131, Colombia

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. 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.

Primary Outcome Measures: 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.

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., 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), 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), 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), 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), 6 months