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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
102
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
Placebo tablet will be identical in appearance to the experimental product (SUMOR).
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
RECRUITINGHamilton Rating Scale for Depression (HAM-D)
The change in total HAM-D score between baseline and the 8-week follow-up was the primary outcomes measure. This measure is a clinician rated inventory of depressive symptoms. All items are scored on scales ranging from 0-2 to 0-4, and the sum of the scores provides the total score for the measure. On this scale, higher scores indicate poorer outcomes. Scores over 24 are considered indicative of severe depressive symptoms.
Time frame: Baseline and 8 weeks
Hamilton Rating Scale for Depression (HAM-D)
The change in total HAM-D score between baseline and the intermediate 2-week and 4-week follow-ups were considered secondary outcomes measures.
Time frame: Baseline, 2 weeks, and 4 weeks
Hamilton Anxiety Scale (HAM-A)
The change in total HAM-A score between baseline and the 2-week, 4-week and 8-week follow-ups were considered secondary outcomes measures. This measure is a clinician rated inventory of anxiety symptoms. The sum of the scores provides the total score for the measure. On this scale, higher scores indicate poorer outcomes.
Time frame: Baseline, 2 weeks, 4 weeks and 8 weeks
SIDE
A self-assessment questionnaire for undesirable effects in psychopharmacological treatment, developed by the Department of Psychiatry of Vanderbilt University in Nashville. It allows to investigate the presence or absence of 48 symptoms, exploring their severity and the relationship with the treatment.
Time frame: Baseline, 2 weeks, 4 weeks and 8 weeks
Depressive symptoms remission
Remission rate of Major Depression in the two groups over the course of treatment, defining remission as a score ≤ 7 on the HAM-D scale
Time frame: Baseline, 2 weeks, 4 weeks and 8 weeks
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