EVALUATION OF EFFICACY OF SAMEUP IN SUBJECTS WITH DEPRESSION SYMPTOMS: A RANDOMIZED STUDY — SAMEUP  

Depressive Symptoms Clinical Trial

Official title: DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY OF SAMEUP IN SUBJECTS CHARACTERIZED BY MILD TO MODERATE DEPRESSION SYMPTOMS

Status Completed

Clinical Trial Summary

This study is planned to assess the efficacy of SAMEUp versus placebo after six weeks of treatment in subjects characterized by depression symptoms according to ICD-10 (International Classification of Diseases - 10th revision) diagnostic criteria and confirmed by mean of Zung's Self-Rating Depression Scale.

Clinical Trial Description

Depression is a common condition of low mood and aversion to activity that can affect a person's thoughts, behaviour, tendencies, feelings, and sense of well-being.

Several literature findings suggest that an oral combination of the two food supplements SAMe (S-adenosyl-L-methionine) and probiotic Lactobacillus plantarum might be favourable in relieving some of symptoms of depression, particularly in the mild to moderate forms of this condition. This double blind placebo controlled clinical study aims to evaluate this hypothesis. In particular, the primary objective is to assess, versus placebo, the efficacy of SAMEUp in improving the overall symptomology of depression after 6 weeks of treatment. Subjects with mild to moderate depression were identified according to ICD-10 diagnostic criteria and confirmed by mean of Zung's Self-Rating Depression Scale.

SAMEUp, the investigational food supplement, is an oral formulation (tablet) containing S-adenosyl methionine (SAMe) 200 mg and Lactobacillus plantarum HEAL9 1x109 CFU, already notified to the Ministry of Health as food supplement.

Placebo is an oral formulation of inert tablet. Placebo and SAMEUp are indistinguishable. ;

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

• NCT number: NCT03932474
• Study type: Interventional
• Source: Nutrilinea srl
• Status: Completed
• Phase: N/A
• Start date: September 17, 2018
• Completion date: November 20, 2018