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出境医 / 临床实验 / EVALUATION OF EFFICACY OF SAMEUP IN SUBJECTS WITH DEPRESSION SYMPTOMS: A RANDOMIZED STUDY (SAMEUP)

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

Study Description
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.

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
Italy
Hippocrates Research
Genoa, Italy, 16121
Sponsors and Collaborators
Nutrilinea srl
Hippocrates Research
Tracking Information
First Submitted Date  ICMJE April 19, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date May 2, 2019
Actual Study Start Date  ICMJE September 17, 2018
Actual Primary Completion Date November 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Evaluation of the patient's satisfaction grade [ Time Frame: 6 weeks ]
    Subject's satisfaction grade at the end of the treatment.
  • Incidence of adverse events described as per frequency and relationship with the study product [ Time Frame: 6 weeks ]
    Adverse events occurrence during the study
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Improvement in IBS 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.
  • 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.
  • 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.
  • 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.
  • Evaluation of the patient's satisfaction grade [ Time Frame: 6 weeks ]
    Subject's satisfaction grade at the end of the treatment.
  • Incidence of adverse events described as per frequency and relationship with the study product [ Time Frame: 6 weeks ]
    Adverse events occurrence during the study
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EVALUATION OF EFFICACY OF SAMEUP IN SUBJECTS WITH DEPRESSION SYMPTOMS: A RANDOMIZED STUDY
Official Title  ICMJE DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY OF SAMEUP IN SUBJECTS CHARACTERIZED BY MILD TO MODERATE DEPRESSION SYMPTOMS
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Depressive Symptoms
Intervention  ICMJE
  • Combination Product: SAMEUp
    One tablet per day of food supplements containing S-adenosyl methionine (SAMe) 200 mg and Lactobacillus plantarum HEAL9 1x109 CFU.
  • Other: Placebo
    One tablet per day identical in shape, size, colour and taste to the SAMEUp tablet
Study Arms  ICMJE
  • 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.
    Intervention: Combination Product: SAMEUp
  • Placebo Comparator: Placebo
    Placebo is an oral formulation of inert tablet. Placebo and SAMEUp are identical in shape, size, colour and taste.
    Intervention: Other: Placebo
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). pii: 19m02578. doi: 10.4088/PCC.19m02578.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2019) 		90
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 20, 2018
Actual Primary Completion Date November 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03932474
Other Study ID Numbers  ICMJE SAMEUP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nutrilinea srl
Study Sponsor  ICMJE Nutrilinea srl
Collaborators  ICMJE Hippocrates Research
Investigators  ICMJE Not Provided
PRS Account Nutrilinea srl
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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