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NCT Number: NCT06496087

Evaluation of DEPREXIL 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundación CR INVESTIGATION INSTITUTE

Bogotá, Bogotá DC, 110131, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DEPREXIL

Dietary Supplement

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

Primary outcomes

  1. 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.

    • 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.

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 11, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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