Sumor as Adjuvant Therapy in Treatment-resistant Major Depression
- Conditions
- Major Depressive Disorder
- Interventions
- Other: PlaceboDietary Supplement: SUMOR
- Registration Number
- NCT04832178
- Lead Sponsor
- Azienda Ospedaliero-Universitaria Careggi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 102
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - SUMOR SUMOR -
- Primary Outcome Measures
Name Time Method Hamilton Rating Scale for Depression (HAM-D) 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
Name Time Method Depressive symptoms remission 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
Hamilton Rating Scale for Depression (HAM-D) 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.
Hamilton Anxiety Scale (HAM-A) 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.
SIDE 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.
Trial Locations
- Locations (1)
Azienda Ospedaliero Universitaria Careggi
🇮🇹Florence, Italy