NCT06765057 | NOT YET RECRUITING | Depression Anxiety Disorder

Detailed Description:

Recently, the United Nations (UN) announced depression as the leading cause of disability worldwide. According to the World Health Organization (WHO), depression can increase the risk of suicide and death. Its prevalence increased globally since 2005 from 4.4% and reached 18.4% in 2015 accounting for about 322 million of the population. Based on the study of the Global Burden of Disease (GBD) from 195 countries around the world including Saudi Arabia, depression incidence increased from 172.27 million to 258.16 million from 1990 to 2017 most of whom is from major depressive disorder (MDD). In addition, according to the Saudi National Mental Health Survey in 2016, 34% of Saudis were having psychiatric disorders and 80% of those with severe situations did not attempt any health care. Moreover, the prevalence of MDD among Saudis was 0.6% and it was one of the top-rated mental health cases in Saudi Arabia. Not only that but also, a cross-sectional study showed that the incidence of depression increased even more among Saudis during the pandemic of coronavirus disease-19 (COVID-19) to be 20.9%. Depression is characterized by a persistent feeling of sadness, loss of interest, feeling of low self-esteem, loss of energy, decreased or increased appetite, trouble sleeping, and thoughts of suicide. Basically, depression is categorized into two main categories which are MDD and persistent depressive disorder (known as dysthymia). Depression can impair the quality of life and well-being. Unfortunately, it can also affect health negatively by causing comorbid diseases such as cancer, heart disease, inflammation, and neurological and metabolic disorders. According to Al-Khatib et al (2022), one of the metabolic disorders associated with depression is metabolic syndrome (MetS). The International Diabetes Federation (IDF) defined the MetS as the occurrence of three or more symptoms of the following: central obesity with waist circumference (WC) for men ≥ 94 centimeters while for women ≥ 80 centimeters, increased fasting plasma glucose (FPG) ≥ 100 mg/dl, increased blood pressure (BP) to ≥ 130 /≥ 85 mmHg, increased triglycerides (TGs) to equal or above 150 mg/dl, reduced high-density lipoprotein cholesterol (HDL-C) for men to \< 40 mg/dl while for women \< 50 mg/dl. As a matter of fact, depression can lead to MetS and vice versa. About 30% of individuals with depression have MetS; meanwhile, about 41% of individuals with depression and MetS also have high levels of inflammation. Individuals with inflammation tend to have obesity and MetS. Thus, in 2007, it was proposed that the onset of depression with comorbid MetS is called "MetS type II" in which a combination of neuronal, psychological, and metabolic disorder happens. Furthermore, Gawlik-Kotelnicka and Strzelecki mentioned in their recent review the term "metabolic depression" to depict the relationship between depression, obesity, and MetS. Recently, it has been suggested that gut microbiota modulation by a combination of probiotics and anti-depressant is an effective treatment. Since the bidirectional relationship between brain and gut health was confirmed, the accumulated body of evidence revealed that mental health is impacted by what is called the gut-brain axis (GBA) in which the gut microbiome can affect brain health through special microorganisms known as psychobiotics. Psychobiotics are special types of probiotics; they are specified to positively influence neurotransmitters, endocrinal hormones, and anti-inflammatory cytokines. They are a supporting therapy as an add-on therapy for mood disorders and depression with little or no side effects. To our knowledge, there are no clinical trials conducting in Saudi Arabia to investigate the impact of probiotics efficiency on depressive symptoms, anthropometric measurement, and MetS components in adult patients which is the aim of this experimental study.