Sumor as Adjuvant Therapy in Treatment-resistant Major Depression

NCT04832178 | Unknown Phase 4

• 1 other identifier: 14976
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Hamilton Rating Scale for Depression (HAM-D)

  Baseline, 2 weeks, and 4 weeks

• Hamilton Anxiety Scale (HAM-A)

  Baseline, 2 weeks, 4 weeks and 8 weeks

• SIDE

  Baseline, 2 weeks, 4 weeks and 8 weeks

• Depressive symptoms remission

  Baseline, 2 weeks, 4 weeks and 8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Other: Placebo

SUMOR

EXPERIMENTAL

Dietary Supplement: SUMOR

Interventions

SUMOR 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

SUMOR

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Careggi

Florence, 50100, Italy

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Francesco Rotella, PhD, MD

  Azienda Ospedaliero-Universitaria Careggi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valdo Ricca, MD

CONTACT

+390557947478; valdo.ricca@unifi.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dirigente Medico 1° livello - Psichiatra

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 5, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)