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

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

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.

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms
• Intervention / Treatment: Combination product: SAMEUp; Other: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Genoa, Italy, 16121
    • Hippocrates Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Written informed consent, personally signed and dated by the subject.
2. Males and females, aging 18-60 years old (limits included).
3. Diagnosis of mild to moderate recurrent depressive disorder according to the ICD-10 / F33 criteria (World Health Organization, 2004).
4. Subject who, having completed the Z-SDS depression questionnaire, has a raw score between 41 and 55 (including limits).
5. 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.

Exclusion Criteria:

1. Pregnant or breast-feeding woman.
2. Subject with one or more psychiatric disturbances, such as: alcoholism, substance abuse or dependency disorder, bipolar disorder, schizophrenia, or other personality disorder.
3. Subject with known or potential hypersensitivity to any ingredient in the study product.
4. Subject in treatment with psycholeptic drug, such as: antipsychotics, anxiolytics, hypnotics and sedatives.
5. Subject who has taken during the 2 weeks prior to inclusion, who is currently taking or plans to take other orally administered food supplements except the study product. Only multivitamins, salts and trace elements are accepted

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SAMEUp; 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; One tablet per day of food supplements containing S-adenosyl methionine (SAMe) 200 mg and Lactobacillus plantarum HEAL9 1x109 CFU.
PLACEBO_COMPARATOR: Placebo; Placebo is an oral formulation of inert tablet. Placebo and SAMEUp are identical in shape, size, colour and taste.	Other: Placebo; One tablet per day identical in shape, size, colour and taste to the SAMEUp tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in the overall depression symptomatology assessed by the Zung's Self-Rating Depression Scale	Absolute change from baseline to two treatment-week of the total score of the Zung's Self-Rating Depression Scale	2 weeks
Improvement in the core depression symptomatology assessed by Zung's Self-Rating Depression Scale	Absolute change from baseline to two treatment-week of the core depressive factor of the Zung's Self-Rating Depression Scale.	2 weeks
Improvement in the core depression symptomatology assessed by Zung's Self-Rating Depression Scale	Absolute change from baseline to six treatment-week of the core depressive factor of the Zung's Self-Rating Depression Scale.	6 weeks
Improvement in the patient's cognition assessed by Zung's Self-Rating Depression Scale	Absolute change from baseline to two treatment-week of the cognitive factor of the Zung's Self-Rating Depression Scale.	2 weeks
Improvement in the patient's cognition assessed by Zung's Self-Rating Depression Scale	Absolute change from baseline to six treatment-week of the cognitive factor of the Zung's Self-Rating Depression Scale.	6 weeks
Improvement in the anxiety condition assessed by Zung's Self-Rating Depression Scale	Absolute change from baseline to two treatment-week of the anxiety factor of the Zung's Self-Rating Depression Scale.	2 weeks
Improvement in the anxiety condition assessed by Zung's Self-Rating Depression Scale	Absolute change from baseline to six treatment-week of the anxiety factor of the Zung's Self-Rating Depression Scale.	6 weeks
Improvement in the somatic condition assessed by Zung's Self-Rating Depression Scale	Absolute change from baseline to two treatment-week of the somatic factor of the Zung's Self-Rating Depression Scale.	2 weeks
Improvement in the somatic condition assessed by Zung's Self-Rating Depression Scale	Absolute change from baseline to six treatment-week of the somatic factor of the Zung's Self-Rating Depression Scale.	6 weeks
Improvement in the overall symptomatology of depression assessed by Zung's Self-Rating Depression Scale	Absolute change from baseline to two treatment-week of the total score of the Zung's Self-Rating Anxiety Scale.	2 weeks
Improvement in the overall symptomatology of depression assessed by Zung's Self-Rating Depression Scale	Absolute change from baseline to six treatment-week of the total score of the Zung's Self-Rating Anxiety Scale.	6 weeks
Improvement in the insomnia condition evaluated through the Insomnia Severity Index	Absolute change from baseline to two treatment-week of the total score of the Insomnia Severity Index.	2 weeks
Improvement in the insomnia condition evaluated through the Insomnia Severity Index	Absolute change from baseline to six treatment-week of the total score of the Insomnia Severity Index.	6 weeks
Improvement in IBS (Irritable Bowel Syndrome) symptoms evaluated through the IBS questionnaire	Absolute change from baseline to two treatment-week of the total score of the IBS questionnaire.	2 weeks
Improvement in IBS symptoms evaluated through the IBS questionnaire	Absolute change from baseline to six treatment-week of the total score of the IBS questionnaire.	6 weeks
Improvement in the overall health status as measured by the EQ-5D-3L questionnaire	Absolute change from baseline to two treatment-week of the EQ-5D-3L questionnaire.	2 weeks
Improvement in the overall health status as measured by the EQ-5D-3L questionnaire	Absolute change from baseline to six treatment-week of the EQ-5D-3L questionnaire.	6 weeks
Evaluation of the patient's satisfaction grade	Subject's satisfaction grade at the end of the treatment.	6 weeks
Incidence of adverse events described as per frequency and relationship with the study product	Adverse events occurrence during the study	6 weeks

Collaborators and Investigators

• Sponsor: Nutrilinea srl
• Collaborators: Hippocrates Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 17, 2018
• Primary Completion (ACTUAL): November 20, 2018
• Study Completion (ACTUAL): November 20, 2018

Study Registration Dates

• First Submitted: April 19, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (ACTUAL): April 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2019
• Last Update Submitted That Met QC Criteria: April 30, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: depression; probiotic; insomnia; anxiety; irritable bowel syndrome; Lactobacillus plantarum 299v; SAMe; randomized controlled study
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: SAMEUP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No