A Pilot Double-Blind Randomized Placebo-Controlled Crossover Study to Investigate Rapid Antidepressant Effects of Leucine
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in QIDS-SR From Baseline at 14 Days
研究概览
简要总结
This randomized double-blind placebo-controlled crossover study seeks to evaluate the antidepressant effect of L-leucine, an essential amino acid, in patients with Major Depressive Disorder (MDD).
详细描述
This is a pilot phase II clinical trial of L-leucine to test its efficacy in reducing depressive symptoms in MDD patients, especially those who exhibit increased inflammation. The determination of increased inflammation will be done post-hoc. During the screening visit, all study participants will provide demographic information and complete self-report assessments and clinician evaluations and examinations. Blood and urine tests will also be performed. All participants who meet eligibility criteria and are willing to proceed with the study will enter this 6-week study after being randomized to two-week course of either L-leucine or placebo. In this cross-over study, participants will be crossed over to the second treatment after 2 weeks of washout. The study period will last 42 days (6 weeks) from the baseline visit. Both L-leucine and placebo will be provided as an effervescent mixture powder. Investigators hypothesize that MDD subjects will have greater reduction in depression severity on leucine as compared to placebo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current primary diagnosis of nonpsychotic major depressive disorder.
- •Stable antidepressant dose of no more than one antidepressant medication for 4 weeks and no anticipated changes during the study period.
- •Stable doses of all concomitant medications for over 6 weeks.
- •No more than two failed antidepressant trials of adequate dose and duration, as defined by ATRQ, in the current episode.
排除标准
- •Psychiatric co-morbidity posing safety risk.
- •Pregnant or breastfeeding or plan to become pregnant over the ensuing 2 months following study entry or are sexually active and not using adequate contraception
- •Exclusionary psychiatric conditions (such as substance dependence in the last 6 months, substance abuse in the last 2 months, or lifetime history of psychotic disorders.
- •Unstable or terminal general medical condition (GMC).
- •Concomitant medications that interact with L-leucine (e.g. sildenafil).
- •Vagus nerve stimulation, ECT, or rTMS, or other somatic antidepressant treatment during current episode
- •Inadequately controlled hypothyroidism.
- •Therapy that is depression specific, such as CBT or Interpersonal Psychotherapy of Depression.
- •Hypersensitivity to L-leucine
- •Have Maple Syrup Urine Disease.
研究组 & 干预措施
L-leucine
4 gm L-leucine by mouth twice daily for two weeks
干预措施: L-Leucine (Drug)
Maltodextrin
4 gm maltodextrin by mouth twice daily for two weeks
干预措施: Maltodextrin (Other)
结局指标
主要结局
Change in QIDS-SR From Baseline at 14 Days
时间窗: Baseline to 14 days
The Quick Inventory of Depressive Symptomatology, self-report (QIDS-SR), self-report is a 16-item measure of depression severity that includes the 9 criterion symptoms for MDD. Items are scored on a 4-point Likert scale, ranging from 0 to 3 (total score range, 0-27). Totals scores of ≤ 5 indicate no depression; 6-10 indicates mild depression; 11-15 indicates moderate depression; 16-20 indicates severe depression; and ≥ 21 indicates very severe depression. For purposes of this report, severe and very severe categories were combined as "severe to very severe" depression (≥ 16). The QIDS-A self-report has demonstrated acceptable psychometric properties.
次要结局
- Percentage of MDD Patients With 50% or Greater Reduction in Depression Severity After 14 Days of LEU and PBO Treatments.(Baseline to 14 days)
- Percentage of MDD Patients With QIDS-SR Score Less Than or Equal to 5 at 14 Days of LEU and PBO Treatments.(14 days)
- Rates of Adverse Effects After 3 Days, 7 Days and 14 Days of LEU and PBO Treatments.(Baseline to 3 days, 7 days, and 14 days)
- Change in Fatigue Symptoms From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured With Multidimensional Fatigue Inventory.(Baseline to 3 days, 7 days, and 14 days)
- Change in Psychosocial Function From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured Using Work and Social Adjustment Scale.(Baseline to 3 days, 7 days, and 14 days)
- Change in Anhedonia From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured Using Snaith-Hamilton Pleasure Scale (SHAPS)(Baseline to 3 days, 7 days, and 14 days)
研究者
Madhukar H. Trivedi, MD
MD
University of Texas Southwestern Medical Center