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| Name | Class |
|---|---|
| Hippocrates Research | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | Placebo is an oral formulation of inert tablet. Placebo and SAMEUp are identical in shape, size, colour and taste. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAMEUp | Combination Product | One tablet per day of food supplements containing S-adenosyl methionine (SAMe) 200 mg and Lactobacillus plantarum HEAL9 1x109 CFU. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hippocrates Research | Genoa | 16121 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32589828 | Derived | 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. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| Placebo | Other | One tablet per day identical in shape, size, colour and taste to the SAMEUp tablet |
|
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 |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |