Evaluation of DEPREXIL Treatment in Patients With Clinical Depression Through Psychological and Neuroendocrine Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To evaluate the psychological state of depressive patients treated with Deprexil® by patient questionnaire test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical depression diagnosed primary or secondary to concomitant illness or post COVID-19.
排除标准
- •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.
结局指标
主要结局
To evaluate the psychological state of depressive patients treated with Deprexil® by patient questionnaire test
时间窗: 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. 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.
To evaluate the psychological state of depressive patients treated with Deprexil® by neuropeptides
时间窗: 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)
To evaluate the psychological state of depressive patients treated with Deprexil® by hormonal levels
时间窗: 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)
次要结局
未报告次要终点
