Ignite Creation Date:
2024-07-17 @ 11:57 AM
Last Modification Date:
2025-12-16 @ 11:05 PM
Study NCT ID:
NCT06496087
Status:
None
Last Update Posted:
2024-07-11 00:00:00
First Post:
2024-06-05 00:00:00
Brief Title:
Evaluation of DEPREXIL in Patients With Clinical Depression Through Psychological and Neuroendocrine Assessment
Sponsor:
Catalysis SL
Organization:
Catalysis SL
Study Overview
Official Title:
Evaluation of DEPREXIL Treatment in Patients With Clinical Depression Through Psychological and Neuroendocrine Assessment
Status:
None
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None