Optimizing Mental Health Management With AI-Guided (GenAIS TM) Dietary Supplementation

Optimizing Mental Health Management With AI-Guided (GenAIS TM) Dietary Supplementation: A Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Mental Disorder
• Intervention / Treatment: Other: Standard therapy group; Other: AI-Guided group

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibisk Region
    • Novosibirsk, Novosibisk Region, Russian Federation, 630090
      • Center of New Medical Technologies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group	Other: Standard therapy group; Participants receive supplement prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.
Experimental: AI-Guided Group	Other: AI-Guided group; Participants receive supplement prescriptions determined by GenAIS, is an AI system that considers genetic data, metabolic profiles, biochemical markers, and patient history.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in specific symptoms of depression and anxiety.		6 months
Incidence of adverse effects related to dietary supplements.		6 months
Percent change in high-sensitivity C-reactive protein		6 months
Percent change in body weight and body mass index		6 months
Number of Participant adherence to the prescribed dietary supplements regimen.		6 months
Changes in quality of life score Short Form Health Survey	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	6 months
Changes in quality of life score World Health Organization Quality of Life	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.	6 months

Collaborators and Investigators

• Sponsor: S.LAB (SOLOWAYS)
• Collaborators: Center of New Medical Technologies; Triangel Scientific

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Actual): May 20, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Depression management; Genetic profiling; metabolic profiling; AI-guided dietary supplementation; anxiety management
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: SW016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No