NCT06496087

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Catalysis SL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-12-15
• Completion: 2024-04-15
• First posted: 2024-07-11
• Last updated: 2024-07-11

Locations

1 site across 1 country: Colombia