CompletedNot Applicable

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

Italy90 participantsStarted 2018-09-17

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Improvement in the overall depression symptomatology assessed by the Zung's Self-Rating Depression Scale

Timeframe: 6 weeks

Trial details

NCT IDNCT03932474

SponsorNutrilinea srl

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11-20

View on ClinicalTrials.gov More Depressive Symptoms trials