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Completed

NCT Number: NCT06470425

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

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.

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Key information

Conditions

Mental Disorder Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

    Time frame: 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 outcomes

  1. Percent change in specific symptoms of depression and anxiety.

    Time frame: 6 months

  2. Percent change in high-sensitivity C-reactive protein

    Time frame: 6 months

  3. Percent change in body weight and body mass index

    Time frame: 6 months

  4. Incidence of adverse effects related to dietary supplements.

    Time frame: 6 months

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

    Time frame: 6 months

  6. Changes in quality of life score Short Form Health Survey

    Time frame: 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

  7. Changes in quality of life score World Health Organization Quality of Life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

S.LAB (SOLOWAYS)

Other

Collaborators

  • Center of New Medical Technologies
  • Triangel Scientific

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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