Evaluation of DEPREXIL in Patients With Clinical Depression Through Psychological and Neuroendocrine Assessment

NCT06496087 | Completed

• 1 other identifier: DEPREXIL_DEPRESSION_CO_2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Post-COVID-19 Syndrome; Depression Mild; Depression Moderate

Keywords

Depression; Antioxidant; Supportive Care; Post-COVID-19 Syndrome; Ginkgo Biloba

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Deprexil Group

EXPERIMENTAL

The trial group will be administered 1 capsule of DEPREXIL orally every 8 hours for 6 months of treatment.

Dietary Supplement: DEPREXIL

Interventions

DEPREXIL DIETARY_SUPPLEMENT

The trial group will be administered 1 capsule of DEPREXIL orally every 8 hours for 6 months of treatment.

Deprexil Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with clinical depression diagnosed primary or secondary to concomitant illness or post COVID-19.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (1)

Fundación CR INVESTIGATION INSTITUTE

Bogotá, Bogotá DC, 110131, Colombia

Location

Related Publications (4)

• 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.

  PMID: 32738287 BACKGROUND

• Perez-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.

  PMID: 33064695 BACKGROUND

• Li 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.

  PMID: 33690641 BACKGROUND

• Mazza 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.

  PMID: 35727534 BACKGROUND

MeSH Terms

Conditions

Depression; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: July 11, 2024
• Study Start: November 1, 2022
• Primary Completion: December 15, 2023
• Study Completion: April 15, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CO (1)