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

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ClinicalTrials.gov Identifier: NCT03932474
Recruitment Status : Completed
First Posted : April 30, 2019
Last Update Posted : May 2, 2019
Sponsor:
Collaborator:
Hippocrates Research
Information provided by (Responsible Party):
Nutrilinea srl

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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Combination Product: SAMEUp Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY OF SAMEUP IN SUBJECTS CHARACTERIZED BY MILD TO MODERATE DEPRESSION SYMPTOMS
Actual Study Start Date : September 17, 2018
Actual Primary Completion Date : November 20, 2018
Actual Study Completion Date : November 20, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Improvement in the overall depression symptomatology assessed by the Zung's Self-Rating Depression Scale [ Time Frame: 2 weeks ]
    Absolute change from baseline to two treatment-week of the total score of the Zung's Self-Rating Depression Scale

  2. Improvement in the core depression symptomatology assessed by Zung's Self-Rating Depression Scale [ Time Frame: 2 weeks ]
    Absolute change from baseline to two treatment-week of the core depressive factor of the Zung's Self-Rating Depression Scale.

  3. Improvement in the core depression symptomatology assessed by Zung's Self-Rating Depression Scale [ Time Frame: 6 weeks ]
    Absolute change from baseline to six treatment-week of the core depressive factor of the Zung's Self-Rating Depression Scale.

  4. Improvement in the patient's cognition assessed by Zung's Self-Rating Depression Scale [ Time Frame: 2 weeks ]
    Absolute change from baseline to two treatment-week of the cognitive factor of the Zung's Self-Rating Depression Scale.

  5. Improvement in the patient's cognition assessed by Zung's Self-Rating Depression Scale [ Time Frame: 6 weeks ]
    Absolute change from baseline to six treatment-week of the cognitive factor of the Zung's Self-Rating Depression Scale.

  6. Improvement in the anxiety condition assessed by Zung's Self-Rating Depression Scale [ Time Frame: 2 weeks ]
    Absolute change from baseline to two treatment-week of the anxiety factor of the Zung's Self-Rating Depression Scale.

  7. Improvement in the anxiety condition assessed by Zung's Self-Rating Depression Scale [ Time Frame: 6 weeks ]
    Absolute change from baseline to six treatment-week of the anxiety factor of the Zung's Self-Rating Depression Scale.

  8. Improvement in the somatic condition assessed by Zung's Self-Rating Depression Scale [ Time Frame: 2 weeks ]
    Absolute change from baseline to two treatment-week of the somatic factor of the Zung's Self-Rating Depression Scale.

  9. Improvement in the somatic condition assessed by Zung's Self-Rating Depression Scale [ Time Frame: 6 weeks ]
    Absolute change from baseline to six treatment-week of the somatic factor of the Zung's Self-Rating Depression Scale.

  10. Improvement in the overall symptomatology of depression assessed by Zung's Self-Rating Depression Scale [ Time Frame: 2 weeks ]
    Absolute change from baseline to two treatment-week of the total score of the Zung's Self-Rating Anxiety Scale.

  11. Improvement in the overall symptomatology of depression assessed by 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 Anxiety Scale.

  12. Improvement in the insomnia condition evaluated through the Insomnia Severity Index [ Time Frame: 2 weeks ]
    Absolute change from baseline to two treatment-week of the total score of the Insomnia Severity Index.

  13. Improvement in the insomnia condition evaluated through the Insomnia Severity Index [ Time Frame: 6 weeks ]
    Absolute change from baseline to six treatment-week of the total score of the Insomnia Severity Index.

  14. Improvement in IBS (Irritable Bowel Syndrome) symptoms evaluated through the IBS questionnaire [ Time Frame: 2 weeks ]
    Absolute change from baseline to two treatment-week of the total score of the IBS questionnaire.

  15. Improvement in IBS symptoms evaluated through the IBS questionnaire [ Time Frame: 6 weeks ]
    Absolute change from baseline to six treatment-week of the total score of the IBS questionnaire.

  16. Improvement in the overall health status as measured by the EQ-5D-3L questionnaire [ Time Frame: 2 weeks ]
    Absolute change from baseline to two treatment-week of the EQ-5D-3L questionnaire.

  17. Improvement in the overall health status as measured by the EQ-5D-3L questionnaire [ Time Frame: 6 weeks ]
    Absolute change from baseline to six treatment-week of the EQ-5D-3L questionnaire.

  18. Evaluation of the patient's satisfaction grade [ Time Frame: 6 weeks ]
    Subject's satisfaction grade at the end of the treatment.

  19. Incidence of adverse events described as per frequency and relationship with the study product [ Time Frame: 6 weeks ]
    Adverse events occurrence during the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932474


Locations
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Italy
Hippocrates Research
Genoa, Italy, 16121
Sponsors and Collaborators
Nutrilinea srl
Hippocrates Research
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nutrilinea srl
ClinicalTrials.gov Identifier: NCT03932474    
Other Study ID Numbers: SAMEUP
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nutrilinea srl:
depression
probiotic
SAMe
Lactobacillus plantarum 299v
anxiety
insomnia
irritable bowel syndrome
randomized controlled study
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms