Sumor as Adjuvant Therapy in Treatment-resistant Major Depression (SUSCA)

Azienda Ospedaliero-Universitaria Careggi

Status and phase

Enrolling

Phase 4

Conditions

Major Depressive Disorder

Treatments

Other: Placebo

Dietary Supplement: SUMOR

Study type

Interventional

Funder types

Other

Identifiers

NCT04832178

14976

Details and patient eligibility

About

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.

Enrollment

102 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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