Sumor as Adjuvant Therapy in Treatment-resistant Major Depression

Study Overview
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Brief Summary
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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.

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Dietary Supplement: SUMOR
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Major Depressive Disorder according to DSM-5 criteria Treatment-resistant status, assessed by clinical interview, after four weeks after SSRI therapy prescription as per NICE guidelines (National Institute for Health and Care Excellence, 2009) Age between 18 and 65 years Signature of informed consent Exclusion Criteria: Presence of intellectual disability or illiteracy Diagnosis of a disorder belonging to the spectrum of schizophrenia or other psychotic disorders according to DSM-5 Diagnosis of a disorder belonging to the bipolar spectrum according to DSM-5 Concomitant intake of therapy with other antidepressants, antipsychotics or mood stabilizers at the time of evaluation or in the previous 4 weeks State of pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo tablet will be identical in appearance to the experimental product (SUMOR).<br>|
| Experimental: SUMOR<br> | Dietary Supplement: SUMOR<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton 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. | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | Baseline, 2 weeks, 4 weeks and 8 weeks |