Official Title
Evaluation of DEPREXIL Treatment in Patients With Clinical Depression Through Psychological and Neuroendocrine Assessment
Brief Summary

Clinical depression is a mood disorder that affects people of all ages with symptoms suchas sadness, anger or frustration, appetite changes, difficulty concentrating and suicidalthoughts. Psychological and pharmacological treatments are available to treat it, such ascognitive behavioral therapy and antidepressants. Deprexil® from Catalysis is a foodsupplement that regulates neuronal metabolism and calcium homeostasis, which may help incases of mild to moderate depression. It is proposed to conduct a study in patients withprimary, secondary or post-COVID-19 depression to evaluate the effects of this supplementon 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.

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

Dietary Supplement: DEPREXIL

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

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Colombia
Locations

Fundación CR INVESTIGATION INSTITUTE
Bogotá 3688689, Bogotá DC, Colombia

Not Provided

NCT Number
Keywords
depression
antioxidant
supportive care
Post-COVID-19 syndrome
Ginkgo Biloba
MeSH Terms
Depression
Post-Acute COVID-19 Syndrome