A Double-Blind, Placebo-Controlled Study of the Alternative Therapy S-Adenosyl-L-Methionine (SAMe) vs Escitalopram in Major Depressive Disorder (MDD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Hamilton Rating Scale for Depression (HAM-D)
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of s-adenosyl-l-methionine (SAMe) in treating major depression.
详细描述
SAMe is a substance that is naturally produced by the body and is also sold as an over-the-counter drug. Although SAMe has not yet been approved for treating depression, evidence suggests that it has antidepressant properties. This study will determine whether SAMe is safe and effective in treating major depression.
This study will last 24 weeks. Participants will be randomly assigned to receive either the antidepressant escitalopram, SAMe, or placebo for 12 weeks. Participants who respond to treatment at the end of 12 weeks will stay on their regimen for an additional 12 weeks. Participants who do not respond to treatment will enter an open treatment phase where they will receive SAMe and escitalopram for 12 more weeks. Depression scales and self-report questionnaires will be used to assess participants. All participants will receive 3 months of follow-up care, including free medication and clinic visits as necessary.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of major depression
- •Score of 25 or higher on the Inventory of Depressive Symptomatology (IDS-C) scale
- •Score of higher than 2 on the Clinical Global Impression Improvement (CGI) scale
- •Willing to use acceptable methods of contraception
排除标准
- •Suicidal or homicidal
- •Unstable illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
- •Any of the following mental conditions: organic mental disorders; schizophrenia; delusional disorder; psychotic disorders; bipolar disorder; recent bereavement; severe borderline or antisocial personality disorder; panic disorder; or obsessive compulsive disorder
- •Substance abuse, including alcohol abuse, within 6 months prior to study entry
- •Uncontrolled seizure disorder, or a seizure disorder controlled with psychotropic anticonvulsants
- •Psychotic features
- •Current use of other psychotropic drugs
- •Hypothyroidism
- •Have taken 6 weeks or more of either escitalopram or SAMe during the current depressive episode
- •Previous intolerance of SAMe or escitalopram
- •Investigational psychotropic drugs within 1 year prior to study entry
- •Have received two or more antidepressant therapies of adequate doses and duration and failed to respond
- •Have received depression-focused psychotherapy
- •Bleeding tissue disorder, low platelet counts, a history of GI bleeding, or use of medications that alter bleeding risk
- •Long-term aspirin use
- •Pregnancy
研究组 & 干预措施
S-adenosyl-l-methionine (SAMe)
A natural substance
干预措施: S-adenosyl-l-methionine (Drug)
2. Escitalopram
A selective serotonin reuptake inhibitor (SSRI)
干预措施: Escitalopram (Drug)
3. placebo
Sugar pill- contains no active ingredients
干预措施: Placebo (Drug)
结局指标
主要结局
Hamilton Rating Scale for Depression (HAM-D)
时间窗: baseline and 24 weeks
The change in total HAM-D score between baseline and endpoint was the primary outcomes measure. This measure is a clinician rated inventory of depressive symptoms. All items are scored on a scale of zero to four and the sum of the scores provides the total score for the measure. Scores can range from 0- 68. On this scale, higher scores indicate poorer outcomes.
次要结局
未报告次要终点
研究者
Maurizio Fava, MD
Director- Depression Clinical and Research Program
Massachusetts General Hospital