Ignite Creation Date:
2024-05-06 @ 1:06 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03932474
Status:
COMPLETED
Last Update Posted:
2019-05-02
First Post:
2019-04-19
Brief Title:
EVALUATION OF EFFICACY OF SAMEUP IN SUBJECTS WITH DEPRESSION SYMPTOMS A RANDOMIZED STUDY
Sponsor:
Nutrilinea srl
Organization:
Nutrilinea srl
Study Overview
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
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAMEUP
Brief 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 Zungs Self-Rating Depression Scale
Detailed Description:
Depression is a common condition of low mood and aversion to activity that can affect a persons 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 Zungs 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
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 Zungs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None