Major Depressive DisorderPhase 4SUSCANCT04832178
Sumor as Adjuvant Therapy in Treatment-resistant Major Depression
A Phase 4 study testing SUMOR in people with Major Depressive Disorder, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- SUMOR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2021to 1 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Careggi
Florence, 50100
Francesco Rotella, PhD, MD, +390557947478, francesco.rotella@unifi.it
Francesco Rotella, PhD, MD
About this study
Official title: Use of Sumor in the Antidepressant Therapy of Subjects With Major Depression: a Randomized Placebo-controlled Clinical Trial
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
- Being tested
- SUMOR, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUMORDietary 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
PlaceboOther
Placebo tablet will be identical in appearance to the experimental product (SUMOR).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| SUMOR | Experimental | Not described Receives: Dietary Supplement: SUMOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks
Secondary outcomes (4)
Hamilton Rating Scale for Depression (HAM-D)
The change in total HAM-D score between baseline and the intermediate 2-week and 4-week follow-ups were considered secondary outcomes measures.
Measured: Baseline, 2 weeks, and 4 weeks
Hamilton Anxiety Scale (HAM-A)
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.
Measured: Baseline, 2 weeks, 4 weeks and 8 weeks
SIDE
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.
Measured: Baseline, 2 weeks, 4 weeks and 8 weeks
Depressive symptoms remission
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
Measured: Baseline, 2 weeks, 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Jun 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Rotella, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Francesco Rotella, PhD, MD, Principal investigator, Azienda Ospedaliero-Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832178
- Sponsor's protocol ID
- 14976
- Acronym
- SUSCA
- Status last verified
- Jan 2024
- First submitted
- 2 Apr 2021
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Sumor in the Antidepressant Therapy of Subjects With Major Depression: a Randomized Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04832178
- Acronym / sponsor ID
- SUSCA / 14976
- Conditions
- Major Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo |
| SUMOR | Experimental | Dietary Supplement: SUMOR |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUMORSUMOR 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 | Dietary supplement | SUMOR |
| PlaceboPlacebo tablet will be identical in appearance to the experimental product (SUMOR). | Other | Placebo |
Primary outcome
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.
4 secondary outcomes
Hamilton Rating Scale for Depression (HAM-D)
Time frame: Baseline, 2 weeks, and 4 weeks
Hamilton Anxiety Scale (HAM-A)
Time frame: Baseline, 2 weeks, 4 weeks and 8 weeks
SIDE
Time frame: Baseline, 2 weeks, 4 weeks and 8 weeks
Depressive symptoms remission
Time frame: Baseline, 2 weeks, 4 weeks and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Rotella, PhD, MD principal investigator
Azienda Ospedaliero-Universitaria Careggi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SUMOR in people with Major Depressive Disorder, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valdo Ricca, MD (+390557947478, valdo.ricca@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression (HAM-D) (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.