NCT03932474

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 Zung's Self-Rating Depression Scale.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

April 19, 2019

Last Update Submit

April 30, 2019

Conditions

Depressive Symptoms

Keywords

depressionprobioticSAMeLactobacillus plantarum 299vanxietyinsomniairritable bowel syndromerandomized controlled study

Outcome Measures

Primary Outcomes (1)

  • Improvement in the overall depression symptomatology assessed by the Zung's Self-Rating Depression Scale

    Absolute change from baseline to six treatment-week of the total score of the Zung's Self-Rating Depression Scale

    6 weeks

Secondary Outcomes (19)

  • Improvement in the overall depression symptomatology assessed by the Zung's Self-Rating Depression Scale

    2 weeks

  • Improvement in the core depression symptomatology assessed by Zung's Self-Rating Depression Scale

    2 weeks

  • Improvement in the core depression symptomatology assessed by Zung's Self-Rating Depression Scale

    6 weeks

  • Improvement in the patient's cognition assessed by Zung's Self-Rating Depression Scale

    2 weeks

  • Improvement in the patient's cognition assessed by Zung's Self-Rating Depression Scale

    6 weeks

  • +14 more secondary outcomes

Study Arms (2)

SAMEUp

EXPERIMENTAL

SAMEUp, the Investigational Food Supplement (IFS), is an oral formulation (tablet) containing S-adenosyl methionine (SAMe) 200 mg and Lactobacillus plantarum HEAL9 1x109 CFU.

Combination Product: SAMEUp

Placebo

PLACEBO COMPARATOR

Placebo is an oral formulation of inert tablet. Placebo and SAMEUp are identical in shape, size, colour and taste.

Other: Placebo

Interventions

SAMEUpCOMBINATION_PRODUCT

One tablet per day of food supplements containing S-adenosyl methionine (SAMe) 200 mg and Lactobacillus plantarum HEAL9 1x109 CFU.

SAMEUp
PlaceboOTHER

One tablet per day identical in shape, size, colour and taste to the SAMEUp tablet

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent, personally signed and dated by the subject.
  • Males and females, aging 18-60 years old (limits included).
  • Diagnosis of mild to moderate recurrent depressive disorder according to the ICD-10 / F33 criteria (World Health Organization, 2004).
  • Subject who, having completed the Z-SDS depression questionnaire, has a raw score between 41 and 55 (including limits).
  • Subject able to comprehend the full nature and purpose of the study, available to cooperate with the Investigator and to comply with the requirements of the entire study.

You may not qualify if:

  • Pregnant or breast-feeding woman.
  • Subject with one or more psychiatric disturbances, such as: alcoholism, substance abuse or dependency disorder, bipolar disorder, schizophrenia, or other personality disorder.
  • Subject with known or potential hypersensitivity to any ingredient in the study product.
  • Subject in treatment with psycholeptic drug, such as: antipsychotics, anxiolytics, hypnotics and sedatives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hippocrates Research

Genoa, 16121, Italy

Location

Related Publications (1)

  • Saccarello A, Montarsolo P, Massardo I, Picciotto R, Pedemonte A, Castagnaro R, Brasesco PC, Guida V, Picco P, Fioravanti P, Montisci R, Schiavetti I, Vanelli A. Oral Administration of S-Adenosylmethionine (SAMe) and Lactobacillus Plantarum HEAL9 Improves the Mild-To-Moderate Symptoms of Depression: A Randomized, Double-Blind, Placebo-Controlled Study. Prim Care Companion CNS Disord. 2020 Jun 25;22(4):19m02578. doi: 10.4088/PCC.19m02578.

    PMID: 32589828DERIVED

MeSH Terms

Conditions

DepressionAnxiety DisordersSleep Initiation and Maintenance DisordersIrritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesColonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2019

First Posted

April 30, 2019

Study Start

September 17, 2018

Primary Completion

November 20, 2018

Study Completion

November 20, 2018

Last Updated

May 2, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)