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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Post-COVID-19 Syndrome; Depression Moderate; Depression Mild
• Intervention / Treatment: Dietary supplement: DEPREXIL

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Bogotá DC
    • Bogotá, Bogotá DC, Colombia, 110131
      • Fundación CR INVESTIGATION INSTITUTE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deprexil Group; The trial group will be administered 1 capsule of DEPREXIL orally every 8 hours for 6 months of treatment.	Dietary supplement: DEPREXIL; The trial group will be administered 1 capsule of DEPREXIL orally every 8 hours for 6 months of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Collaborators and Investigators

• Sponsor: Catalysis SL

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Supportive Care; Antioxidant; Ginkgo Biloba; Post-COVID-19 Syndrome
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Mood Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Depression; Depressive Disorder; COVID-19
• Other Study ID Numbers: DEPREXIL_DEPRESSION_CO_2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No