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

S.LAB (SOLOWAYS)

Status: Completed

Conditions: Mental Disorder

Treatments: Other: Standard therapy group; Other: AI-Guided group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06470425

SW016

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups

Control Group

Active Comparator group

Treatment:

Other: Standard therapy group

AI-Guided Group

Experimental group

Treatment:

Other: AI-Guided group