NCT04832178

Sumor as Adjuvant Therapy in Treatment-resistant Major Depression

Use of Sumor in the Antidepressant Therapy of Subjects With Major Depression: a Randomized Placebo-controlled Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Azienda Ospedaliero-Universitaria Careggi · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Major Depressive Disorder

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2021-04-05
• Last updated: 2024-02-01

Locations

1 site across 1 country: Italy