Clinical trial NCT03932474: EVALUATION OF EFFICACY OF SAMEUP IN SUBJECTS WITH DEPRESSION SYMPTOMS: A RANDOMIZED STUDY
Official title: DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY OF SAMEUP IN SUBJECTS CHARACTERIZED BY MILD TO MODERATE DEPRESSION SYMPTOMS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Keywords: depression
probiotic
SAMe
Lactobacillus plantarum 299v
anxiety
insomnia
irritable bowel syndrome
randomized controlled study
Lead sponsor: Nutrilinea srl
Sponsor class: INDUSTRY
Collaborators: name: Hippocrates Research
First posted: 2019-04-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Improvement in the overall depression symptomatology assessed by the Zung's Self-Rating Depression Scale
timeFrame: 6 weeks
Secondary outcomes:
measure: Improvement in the overall depression symptomatology assessed by the Zung's Self-Rating Depression Scale
timeFrame: 2 weeks
measure: Improvement in the core depression symptomatology assessed by Zung's Self-Rating Depression Scale
timeFrame: 2 weeks
measure: Improvement in the core depression symptomatology assessed by Zung's Self-Rating Depression Scale
timeFrame: 6 weeks
measure: Improvement in the patient's cognition assessed by Zung's Self-Rating Depression Scale
timeFrame: 2 weeks
measure: Improvement in the patient's cognition assessed by Zung's Self-Rating Depression Scale
timeFrame: 6 weeks
measure: Improvement in the anxiety condition assessed by Zung's Self-Rating Depression Scale
timeFrame: 2 weeks
measure: Improvement in the anxiety condition assessed by Zung's Self-Rating Depression Scale
timeFrame: 6 weeks
measure: Improvement in the somatic condition assessed by Zung's Self-Rating Depression Scale
timeFrame: 2 weeks
measure: Improvement in the somatic condition assessed by Zung's Self-Rating Depression Scale
timeFrame: 6 weeks
measure: Improvement in the overall symptomatology of depression assessed by Zung's Self-Rating Depression Scale
timeFrame: 2 weeks
measure: Improvement in the overall symptomatology of depression assessed by Zung's Self-Rating Depression Scale
timeFrame: 6 weeks
measure: Improvement in the insomnia condition evaluated through the Insomnia Severity Index
timeFrame: 2 weeks
measure: Improvement in the insomnia condition evaluated through the Insomnia Severity Index
timeFrame: 6 weeks
measure: Improvement in IBS (Irritable Bowel Syndrome) symptoms evaluated through the IBS questionnaire
timeFrame: 2 weeks
measure: Improvement in IBS symptoms evaluated through the IBS questionnaire
timeFrame: 6 weeks
measure: Improvement in the overall health status as measured by the EQ-5D-3L questionnaire
timeFrame: 2 weeks
measure: Improvement in the overall health status as measured by the EQ-5D-3L questionnaire
timeFrame: 6 weeks
measure: Evaluation of the patient's satisfaction grade
timeFrame: 6 weeks
measure: Incidence of adverse events described as per frequency and relationship with the study product
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: Hippocrates Research
Study officials:
References:
citation: 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.