TRD - 2: A Double-Blind, Placebo Controlled Study of 6(S)-5-MTHF Among SSRI-Resistant Outpatients With Major Depressive Disorder (MDD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 6
- 主要终点
- The 17-item Hamilton Depression Scale (HAM-D-17)
研究概览
简要总结
The purpose of the study is to test whether oral 6(S)-5-MTHF (Deplin) is safe and effective in relieving depression when it is added to standard kinds of antidepressants called serotonin reuptake inhibitors (SSRIs).
详细描述
The study consists of two phases, each lasting a total of four weeks (8 weeks total), with visits at the DCRP every 10 days. If the subject is eligible, they will be asked to return two weeks later for a baseline visit, when they will be randomly assigned, like a flip of a coin, to one of three treatment groups: a) drug/drug, b) placebo/drug, c) placebo/placebo (a placebo is a pill that looks like a study drug but contains no active medication). They will have a greater than 50% chance of receiving active medication (Deplin) at some point in the 8 week study.
Neither the subject nor the research staff will know which group the subject is in.
All subjects will be asked to take the study medication in the morning, in addition to their ongoing SSRI treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •18-65 years old
- •Meet criteria for current Major Depressive Disorder
- •Currently taking an SSRI
排除标准
- •Pregnant women
- •Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
- •Prior course of MTHF augmentation, or intolerance to MTHF at any dose
- •Substance use disorders active within the last six months, any bipolar disorder (current or past), any psychotic disorder (current or past)
- •Have failed more than 2 adequate antidepressant trials during the current Major Depressive Episode
研究组 & 干预措施
6(S)-5-MTHF(Deplin)
Participants will receive 15 mg/day of Deplin, a medical food, for 8 weeks.
The SPCD approach, is modified and conducted as follows:
The phase II dataset of interest is limited to patients treated with placebo during phase I who completed phase I, who did not experience a clinical response according to the HDRS-17 during phase I and entered phase II. Drug is compared to placebo in phase II for this patient subset alone.
The ITT/LOCF data comparing drug and placebo during phase I is combined with the data comparing drug and placebo according to the SPCD model for phase II (see steps 2 and 3 above), and analyzed using the statistical model as described in Fava et al, 2003
干预措施: 6(S)-5-MTHF(Deplin) (Other)
Placebo/Deplin
Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
The SPCD approach, is modified and conducted as follows:
The phase II dataset of interest is limited to patients treated with placebo during phase I who completed phase I, who did not experience a clinical response according to the HDRS-17 during phase I and entered phase II. Drug is compared to placebo in phase II for this patient subset alone.
The ITT/LOCF data comparing drug and placebo during phase I is combined with the data comparing drug and placebo according to the SPCD model for phase II (see steps 2 and 3 above), and analyzed using the statistical model as described in Fava et al, 2003
干预措施: 6(S)-5-MTHF(Deplin) (Other)
Placebo/Deplin
Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
The SPCD approach, is modified and conducted as follows:
The phase II dataset of interest is limited to patients treated with placebo during phase I who completed phase I, who did not experience a clinical response according to the HDRS-17 during phase I and entered phase II. Drug is compared to placebo in phase II for this patient subset alone.
The ITT/LOCF data comparing drug and placebo during phase I is combined with the data comparing drug and placebo according to the SPCD model for phase II (see steps 2 and 3 above), and analyzed using the statistical model as described in Fava et al, 2003
干预措施: Placebo (Other)
Placebo/Placebo
Participants will receive placebo for both phases of the study.
The SPCD approach, is modified and conducted as follows:
The phase II dataset of interest is limited to patients treated with placebo during phase I who completed phase I, who did not experience a clinical response according to the HDRS-17 during phase I and entered phase II. Drug is compared to placebo in phase II for this patient subset alone.
The ITT/LOCF data comparing drug and placebo during phase I is combined with the data comparing drug and placebo according to the SPCD model for phase II (see steps 2 and 3 above), and analyzed using the statistical model as described in Fava et al, 2003
干预措施: Placebo (Other)
结局指标
主要结局
The 17-item Hamilton Depression Scale (HAM-D-17)
时间窗: Baseline and Day 60
The HAM-D-17 is a multiple choice questionnaire that clinicians may use to rate the severity of a patient's major depression. Items are scored on a scale of zero to four and higher scores indicate greater impairment. This scale is scored by summing the scores on each item and scores can range from 0-68. When assessing changes in HAMD score, negative changes indicate improvement (i.e. the score has decreased) and positive scores indicate a worsening of symptoms (i.e. scores have increased).
次要结局
- The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)(Baseline and Day 60)
研究者
George I. Papakostas
Director of Treatment Resistant Depression Studies-DCRP
Massachusetts General Hospital