Sumor as Adjuvant Therapy in Treatment-resistant Major Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-06-01

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.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

SUMOR

Group Type EXPERIMENTAL

SUMOR

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No