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

• ClinicalTrials.gov Identifier: NCT04832178
• Recruitment Status: Recruiting
• First Posted: April 5, 2021
• Last Update Posted: October 22, 2021
• Sponsor: Azienda Ospedaliero-Universitaria Careggi
• Information provided by (Responsible Party): Francesco Rotella, Azienda Ospedaliero-Universitaria Careggi

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder	Dietary Supplement: SUMOR; Other: Placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Use of Sumor in the Antidepressant Therapy of Subjects With Major Depression: a Randomized Placebo-controlled Clinical Trial
• Actual Study Start Date: June 1, 2021
• Estimated Primary Completion Date: June 1, 2023
• Estimated Study Completion Date: June 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo tablet will be identical in appearance to the experimental product (SUMOR).
Experimental: SUMOR	Dietary Supplement: 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

Outcome Measures

Primary Outcome Measures :

1. Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: Baseline and 8 weeks ]
   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.

Secondary Outcome Measures :

1. Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: Baseline, 2 weeks, and 4 weeks ]
   The change in total HAM-D score between baseline and the intermediate 2-week and 4-week follow-ups were considered secondary outcomes measures.
2. Hamilton Anxiety Scale (HAM-A) [ Time Frame: Baseline, 2 weeks, 4 weeks and 8 weeks ]
   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.
3. SIDE [ Time Frame: Baseline, 2 weeks, 4 weeks and 8 weeks ]
   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.
4. Depressive symptoms remission [ Time Frame: Baseline, 2 weeks, 4 weeks and 8 weeks ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Valdo Ricca, MD; +390557947478; valdo.ricca@unifi.it

Locations

Italy

Azienda Ospedaliero Universitaria Careggi; Recruiting

Florence, Italy, 50100

Contact: Francesco Rotella, PhD, MD +390557947478 francesco.rotella@unifi.it

Principal Investigator: Francesco Rotella, PhD, MD

Sub-Investigator: Emanuele Cassioli, MD

Sub-Investigator: Daniele Busatta, MD

Sponsors and Collaborators

Azienda Ospedaliero-Universitaria Careggi

Investigators

• Principal Investigator: Francesco Rotella, PhD, MD; Azienda Ospedaliero-Universitaria Careggi

More Information

• Responsible Party: Francesco Rotella, Dirigente Medico 1° livello - Psichiatra, Azienda Ospedaliero-Universitaria Careggi
• ClinicalTrials.gov Identifier: NCT04832178
• Other Study ID Numbers: 14976
• First Posted: April 5, 2021
• Last Update Posted: October 22, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depressive Disorder; Depressive Disorder, Major; Mood Disorders; Mental Disorders