Mental Disorder
Conditions
Keywords
AI-guided dietary supplementation, Genetic profiling, metabolic profiling, Depression management, anxiety management
Brief summary
The study Optimizing Mental Health Management with AI-Guided (GenAIS TM) Dietary Supplementation aimed to compare the effectiveness of AI-guided dietary supplement (DS) prescriptions versus standard physician-guided prescriptions in managing mental health disorders, specifically depression and anxiety. This 6-month randomized controlled trial included 160 participants diagnosed with major depressive disorder or generalized anxiety disorder. Participants were divided into two groups: one received DS based on physician judgment, and the other based on GenAIS AI system analysis. Primary outcomes focused on changes in mental health scores, while secondary outcomes included quality of life, metabolic markers, and DS adherence. Data collection involved genetic, metabolic, and clinical profiling, with ethical considerations ensuring participant confidentiality and informed consent.
Interventions
Participants receive supplement prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.
OTHERAI-Guided group
Participants receive supplement prescriptions determined by GenAIS, is an AI system that considers genetic data, metabolic profiles, biochemical markers, and patient history.
Sponsors
Triangel Scientific
Center of New Medical Technologies
S.LAB (SOLOWAYS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 65 years. * Diagnosed with major depressive disorder (MDD) or generalized anxiety disorder (GAD) according to DSM-5 criteria. * Moderate to severe symptoms as indicated by scores on HAM-D (≥17) for depression or GAD-7 (≥10) for anxiety. * Stable on psychiatric medication for at least 3 months prior to the study. * Willingness to provide genetic and metabolic data. * Written informed consent.
Exclusion criteria
* Current or past history of severe psychiatric conditions such as schizophrenia, bipolar disorder, or other psychotic disorders. * Current substance abuse or dependence within the last 6 months. * Significant medical conditions like severe renal, hepatic, or cardiovascular diseases. * Pregnancy or breastfeeding. * Recent changes in psychiatric medication within the last 3 months. * Participation in another clinical trial within the last 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint is the percent change in mental health scores (Hamilton Depression Rating Scale, Generalized Anxiety Disorder 7-item scale) for the AI-Guided group compared with the Control group. | 6 months | The Hamilton Depression Rating Scale is a clinician-administered assessment used to measure the severity of depression in individuals. It consists of 17 to 21 items, with each item scored on a scale of 0 to 4 or 0 to 2. The Generalized Anxiety Disorder 7-item scale (GAD-7) is a self-administered questionnaire used to screen for and measure the severity of generalized anxiety disorder. It consists of 7 items, each scored from 0 (not at all) to 3 (nearly every day), with the total score ranging from 0 to 21. Higher scores indicate greater anxiety severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in high-sensitivity C-reactive protein | 6 months | — |
| Percent change in body weight and body mass index | 6 months | — |
| Incidence of adverse effects related to dietary supplements. | 6 months | — |
| Percent change in specific symptoms of depression and anxiety. | 6 months | — |
| Changes in quality of life score Short Form Health Survey | 6 months | Short Form Health Survey, which has a score range from 0 to 100, to measure the quality of life in participants, with higher scores indicating better health and well-being |
| Changes in quality of life score World Health Organization Quality of Life | 6 months | World Health Organization Quality of Life - BREF, which has a score range from 0 to 100, to measure the quality of life in participants, with higher scores indicating better quality of life. |
| Number of Participant adherence to the prescribed dietary supplements regimen. | 6 months | — |
Countries
Russia
Outcome results
None listed