Use of Sumor in the Antidepressant Therapy of Subjects With Major Depression: a Randomized Placebo-controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Hamilton Rating Scale for Depression (HAM-D)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Hamilton Rating Scale for Depression (HAM-D)
时间窗: 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.
次要结局
- Depressive symptoms remission(Baseline, 2 weeks, 4 weeks and 8 weeks)
- Hamilton Rating Scale for Depression (HAM-D)(Baseline, 2 weeks, and 4 weeks)
- Hamilton Anxiety Scale (HAM-A)(Baseline, 2 weeks, 4 weeks and 8 weeks)
- SIDE(Baseline, 2 weeks, 4 weeks and 8 weeks)
研究者
Francesco Rotella
Dirigente Medico 1° livello - Psichiatra
Azienda Ospedaliero-Universitaria Careggi