An interventional study of DEPREXIL in Depression, Post-COVID-19 Syndrome and Depression Mild, sponsored by Catalysis SL. Completed at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-11.
Sponsored by Catalysis SL · Not applicable, Interventional, and Treatment
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.
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 100 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Catalysis SL is the lead sponsor of 53 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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.
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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 6 months
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Ran from Nov 2022 to primary completion in Dec 2023, 13 months.
Of 98 industry-sponsored interventional studies with no phase under Depression, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's 13 months is above that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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