Using Sumor to help treat major depression that doesn't respond to standard medications
Use of Sumor in the Antidepressant Therapy of Subjects With Major Depression: a Randomized Placebo-controlled Clinical Trial
This study is testing if a food supplement called Sumor can help adults with major depression who haven't improved with regular medications feel better when taken with their usual antidepressant.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria Careggi Academic / other |
| Locations | 1 site (Florence) |
| Trial ID | NCT04832178 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Sumor, a food supplement containing key coenzymes and vitamins, as an adjuvant therapy for patients with treatment-resistant Major Depressive Disorder. Participants will receive either Sumor in combination with an SSRI antidepressant or a placebo alongside their SSRI treatment. The study aims to determine if this combination can improve depressive symptoms compared to a placebo. The trial is designed for adults aged 18 to 65 who have not responded adequately to standard SSRI therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 diagnosed with Major Depressive Disorder who have not responded to SSRI treatment.
Not a fit: Patients with bipolar disorder, schizophrenia, or those currently taking other antidepressants or mood stabilizers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for patients suffering from treatment-resistant depression.
How similar studies have performed: There are currently no published studies on the efficacy of this specific combination of ingredients for treating depression, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Florence
- Azienda Ospedaliero Universitaria Careggi — Florence, Italy (Recruiting)
Study contacts
- Principal investigator: Francesco Rotella, PhD, MD — Azienda Ospedaliero-Universitaria Careggi
- Study coordinator: Valdo Ricca, MD
- Email: valdo.ricca@unifi.it
- Phone: +390557947478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.