Clinical trial NCT06470425: Optimizing Mental Health Management With AI-Guided (GenAIS TM) Dietary Supplementation
Official title: Optimizing Mental Health Management With AI-Guided (GenAIS TM) Dietary Supplementation: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder
Keywords: AI-guided dietary supplementation
Genetic profiling
metabolic profiling
Depression management
anxiety management
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: Triangel Scientific
name: Center of New Medical Technologies
First posted: 2024-06-24
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: Percent change in specific symptoms of depression and anxiety.
timeFrame: 6 months
measure: Percent change in high-sensitivity C-reactive protein
timeFrame: 6 months
measure: Percent change in body weight and body mass index
timeFrame: 6 months
measure: Incidence of adverse effects related to dietary supplements.
timeFrame: 6 months
measure: Number of Participant adherence to the prescribed dietary supplements regimen.
timeFrame: 6 months
measure: Changes in quality of life score Short Form Health Survey
timeFrame: 6 months
measure: Changes in quality of life score World Health Organization Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center of New Medical Technologies
state: Novosibisk Region
Study officials:
References: