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Sumor as Adjuvant Therapy in Treatment-resistant Major Depression

NCT04832178 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2024-02-01

No results posted yet for this study

Summary

Sumor is a food supplement that combines the main coenzymes of the S-Adenosyl methionine (SAMe) cycle, namely vitamins B6, B12 and folate, with SAMe and betaine. Sumor also contains vitamin C, a molecule that has shown promise in the treatment of depression in experimental models, and selenium, an antioxidant agent whose blood deficiency has been associated with depressive symptoms in some preliminary studies. There are no studies in the literature on the efficacy of this combination in the adjuvant therapy of depression. The purpose of this study is to compare the effects of Sumor in co-therapy with an SSRI antidepressant versus co-therapy with placebo in patients with treatment-resistant Major Depressive Disorder.

Conditions

Interventions

DIETARY_SUPPLEMENT

SUMOR

SUMOR is a food supplement distributed in Italy by ArcaPharma. regularly entered in the register of Food Supplements of the Ministry of Health (number 62590). Formulated in prolonged-release tablets, each tablet contains the following substances: * S-Adenosyl-L-Methionine sulfate p-toluenesulfonate 250 mg * Betaine hydrochloride 250 mg * Vitamin C 80 mg * Vitamin B1 1.1 mg * Vitamin B2 1.4 mg * Vitamin B6 1.4 mg * Vitamin B12 2,5 µg * Folic Acid 200 µg * Selenium 37 µg

OTHER

Placebo

Placebo tablet will be identical in appearance to the experimental product (SUMOR).

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

    lead OTHER

Principal Investigators

  • Francesco Rotella, PhD, MD · Azienda Ospedaliero-Universitaria Careggi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-06-01
Completion
2024-06-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04832178 on ClinicalTrials.gov