Sumor as Adjuvant Therapy in Treatment-resistant Major Depression

Last updated: January 30, 2024
Sponsor: Azienda Ospedaliero-Universitaria Careggi
Overall Status: Active - Recruiting

Phase

4

Condition

Depression (Major/severe)

Depression

Depression (Adult And Geriatric)

Treatment

Placebo

SUMOR

Clinical Study ID

NCT04832178
14976
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Major Depressive Disorder according to DSM-5 criteria
  • Treatment-resistant status, assessed by clinical interview, after four weeks afterSSRI therapy prescription as per NICE guidelines (National Institute for Health andCare Excellence, 2009)
  • Age between 18 and 65 years
  • Signature of informed consent

Exclusion

Exclusion Criteria:

  • Presence of intellectual disability or illiteracy
  • Diagnosis of a disorder belonging to the spectrum of schizophrenia or other psychoticdisorders 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 moodstabilizers at the time of evaluation or in the previous 4 weeks
  • State of pregnancy

Study Design

Total Participants: 102
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
June 01, 2021
Estimated Completion Date:
June 01, 2024

Connect with a study center

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50100
    Italy

    Active - Recruiting

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