The beneficial effect on mood of a food supplement based on S-adenosyl methionine and probiotics

Not Applicable

Completed

Conditions: Subthreshold depression
Mental and Behavioural Disorders

Registration Number: ISRCTN42589932

Lead Sponsor: Truffini & Reggè Farmaceutici S.r.l.

Brief Summary: 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36411659/ (added 19/04/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

Inclusion Criteria

1. Male and female in the age range 18 to 65 years
2. Subjects who present with altered mood tone
3. Subjects not eligible for antidepressant drugs
4. Subjects capable of understanding and complying with the requirements of the protocol

Exclusion Criteria

1. Subjects with major depression remission or who have suffered from major depression in recent years
2. Individuals who have taken products, drugs or dietary supplements with psychological function activities in the 12 weeks prior to recruitment
3. Subjects suffering from diseases involving the cardiovascular, hepatic, renal, respiratory, nervous or lymphatic system
4. Subjects suffering from hypothyroidism
5. Pregnant women and those who have taken monoamine oxidase inhibitors in the 14 days prior to the recruitment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subthreshold depression as a risk factor for major depression, measured by the Patient Health Questionnaire-9 (PHQ-9) and Hamilton Depression Rating Scale (HAMD21) at t0, t12, t16 and t28

Secondary Outcome Measures