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

A study testing SAMEUp in people with Depressive Symptoms, run by Nutrilinea srl at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Depressive Symptoms
What is being tested?: SAMEUp
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 1 siteItaly
Study dates: 17 Sep 2018to 20 Nov 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.
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

Trial locations and contacts

1 site in 1 country.

Italy1 site

Hippocrates Research
Genoa, 16121

Other trials in Italy

About this study

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

Read the 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.

Conditions: Depressive Symptoms
Being tested: SAMEUp, Placebo
Keywords: depression, probiotic, SAMe, Lactobacillus plantarum 299v, anxiety, insomnia, irritable bowel syndrome, randomized controlled study
Medical subject headings: Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders, Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SAMEUpCombination product
One tablet per day of food supplements containing S-adenosyl methionine (SAMe) 200 mg and Lactobacillus plantarum HEAL9 1x109 CFU.
PlaceboOther
One tablet per day identical in shape, size, colour and taste to the SAMEUp tablet

Study groups in NCT03932474
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 6 weeks

Secondary outcomes (19)

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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Evaluation of the patient's satisfaction grade
Subject's satisfaction grade at the end of the treatment.
Measured: 6 weeks
Incidence of adverse events described as per frequency and relationship with the study product
Adverse events occurrence during the study
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Sep 201820 Nov 2018

First posted30 Apr 2019
Study start17 Sep 2018
Primary completion20 Nov 2018
Study completion20 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Depressive SymptomsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03932474
Sponsor's protocol ID: SAMEUP
Acronym: SAMEUP
Status last verified: Apr 2019
First submitted: 19 Apr 2019
Last updated: 2 May 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 32589828

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depressive Symptoms trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY OF SAMEUP IN SUBJECTS CHARACTERIZED BY MILD TO MODERATE DEPRESSION SYMPTOMS
ClinicalTrials.gov ID: NCT03932474
Acronym / sponsor ID: SAMEUP / SAMEUP
Conditions: Depressive Symptoms
Keywords: depression, probiotic, SAMe, Lactobacillus plantarum 299v, anxiety, insomnia, irritable bowel syndrome, randomized controlled study
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Nutrilinea srlIndustry (pharma, biotech, devices)
Collaborators: Hippocrates Research
Study start: 17 Sep 2018 (actual)
Primary completion: 20 Nov 2018 (actual)
Study completion: 20 Nov 2018 (actual)
First posted: 30 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
SAMEUp	Experimental	Combination Product: SAMEUpSAMEUp, the Investigational Food Supplement (IFS), is an oral formulation (tablet) containing S-adenosyl methionine (SAMe) 200 mg and Lactobacillus plantarum HEAL9 1x109 CFU.
Placebo	Placebo comparator	Other: PlaceboPlacebo is an oral formulation of inert tablet. Placebo and SAMEUp are identical in shape, size, colour and taste.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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.
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SAMEUpOne tablet per day of food supplements containing S-adenosyl methionine (SAMe) 200 mg and Lactobacillus plantarum HEAL9 1x109 CFU.	Combination product	SAMEUp
PlaceboOne tablet per day identical in shape, size, colour and taste to the SAMEUp tablet	Other	Placebo

Primary outcome

Improvement in the overall depression symptomatology assessed by the Zung's Self-Rating Depression Scale
Time frame: 6 weeks
Absolute change from baseline to six treatment-week of the total score of the Zung's Self-Rating Depression Scale

19 secondary outcomes

Improvement in the overall depression symptomatology assessed by the Zung's Self-Rating Depression Scale
Time frame: 2 weeks
Improvement in the core depression symptomatology assessed by Zung's Self-Rating Depression Scale
Time frame: 2 weeks
Improvement in the core depression symptomatology assessed by Zung's Self-Rating Depression Scale
Time frame: 6 weeks
Improvement in the patient's cognition assessed by Zung's Self-Rating Depression Scale
Time frame: 2 weeks
Improvement in the patient's cognition assessed by Zung's Self-Rating Depression Scale
Time frame: 6 weeks
Improvement in the anxiety condition assessed by Zung's Self-Rating Depression Scale
Time frame: 2 weeks
Improvement in the anxiety condition assessed by Zung's Self-Rating Depression Scale
Time frame: 6 weeks
Improvement in the somatic condition assessed by Zung's Self-Rating Depression Scale
Time frame: 2 weeks
Improvement in the somatic condition assessed by Zung's Self-Rating Depression Scale
Time frame: 6 weeks
Improvement in the overall symptomatology of depression assessed by Zung's Self-Rating Depression Scale
Time frame: 2 weeks
Improvement in the overall symptomatology of depression assessed by Zung's Self-Rating Depression Scale
Time frame: 6 weeks
Improvement in the insomnia condition evaluated through the Insomnia Severity Index
Time frame: 2 weeks
Improvement in the insomnia condition evaluated through the Insomnia Severity Index
Time frame: 6 weeks
Improvement in IBS (Irritable Bowel Syndrome) symptoms evaluated through the IBS questionnaire
Time frame: 2 weeks
Improvement in IBS symptoms evaluated through the IBS questionnaire
Time frame: 6 weeks
Improvement in the overall health status as measured by the EQ-5D-3L questionnaire
Time frame: 2 weeks
Improvement in the overall health status as measured by the EQ-5D-3L questionnaire
Time frame: 6 weeks
Evaluation of the patient's satisfaction grade
Time frame: 6 weeks
Incidence of adverse events described as per frequency and relationship with the study product
Time frame: 6 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
Derived from this study: PubMed 32589828Saccarello 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.
Individual participant dataSharing planned: No

Related trials for Depressive Symptoms

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
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RecruitingObservational study
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Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SAMEUp in people with Depressive Symptoms, run by Nutrilinea srl at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in the overall depression symptomatology assessed by the Zung's Self-Rating Depression Scale (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03932474, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.