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

NCT06470425 | Completed

• 1 other identifier: SW016
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorder

Keywords

AI-guided dietary supplementation; Genetic profiling; metabolic profiling; Depression management; anxiety management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Percent change in specific symptoms of depression and anxiety.

  6 months

• 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

• Number of Participant adherence to the prescribed dietary supplements regimen.

  6 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Other: Standard therapy group

AI-Guided Group

EXPERIMENTAL

Other: AI-Guided group

Interventions

Standard therapy group OTHER

Participants receive supplement prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.

Control Group

AI-Guided group OTHER

Participants receive supplement prescriptions determined by GenAIS, is an AI system that considers genetic data, metabolic profiles, biochemical markers, and patient history.

AI-Guided Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead
• Triangel Scientific: collaborator
• Center of New Medical Technologies: collaborator

Study Sites (1)

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Location

MeSH Terms

Conditions

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: February 2, 2024
• Primary Completion: May 20, 2024
• Study Completion: June 1, 2024
• Last Updated: April 11, 2025

Record last verified: 2024-06

Locations

RU (1)