Status:
RECRUITING
Sumor as Adjuvant Therapy in Treatment-resistant Major Depression
Lead Sponsor:
Azienda Ospedaliero-Universitaria Careggi
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 molec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04832178
Start Date
June 1 2021
End Date
June 1 2024
Last Update
February 1 2024
Active Locations (1)
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1
Azienda Ospedaliero Universitaria Careggi
Florence, Italy, 50100