Clinical and Imaging Biomarker Trial of Uridine for Veterans With Suicidal Ideation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change From Baseline in Beck Scale for Suicide Ideation (BSSI)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study of the investigational drug uridine as a treatment for suicidal ideation in veterans.
The investigators hypothesize that the administration of a naturally occurring dietary supplement, uridine, will rapidly reduce suicidal ideation in veterans. The purpose of this study is to determine whether 4 weeks of uridine supplementation is an effective treatment for suicidal ideation in veterans, when compared to a group taking a placebo.
详细描述
Veteran suicides, attempts and suicidal ideation (SI) remain an urgent concern for the Veterans Health Administration (VHA). Research indicates that approximately half of veteran suicides take place within 1 month of the decedent's final VHA encounter, with one quarter occurring within 1 week. This provides a temporal window of opportunity to intervene, and necessitates development of a rapid-acting treatment for veterans with SI. Uridine shares similar brain mechanisms and neural effects with ketamine and lithium, treatments commonly used to reduce suicidal ideation. This study will test the novel intervention uridine as a rapid-acting oral treatment for veterans with suicidal ideation. The purpose of this study is to investigate whether uridine can decrease suicidal ideation in veterans when taken daily for 4 weeks.
In addition to treatment with the investigational drug versus placebo, the study includes a translational neuroimaging component: magnetic resonance spectroscopy (1H-MRS) brain scans are performed at baseline, and then repeated following 1 week of treatment with uridine or placebo. The scans do not use radiation, and are performed on a 3 Tesla MRI system that is approved for clinical use. The scans allow researchers to measure the concentrations of several chemicals in the brain that are may be involved in suicidal ideation.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be able to Provide Informed Consent.
- •Must be a Veteran of the U.S. Armed Forces.
- •Columbia-Suicide Severity Rating Scale Indicates Current Suicidal Ideation
- •Beck Scale for Suicide Ideation Score > 3 (i.e. "Greater Than or Equal to 4").
- •History of > 1 Suicide Attempt or Hospitalization to Prevent Suicide in Past 12 Months; or Functionally Impairing Suicidal Ideation Not Due to a DSM Axis II Diagnosis, in the Past 12 Months.
- •Females and Males Ages 18-55 Inclusive.
- •Willing and Able to Identify an Alternative Contact Person, e.g. Family Member, Friend or Neighbor.
排除标准
- •Schizophrenia or Other Psychotic Disorder.
- •Active Substance Use Disorder Requiring Stabilization (N.B. Does Not Include Nicotine).
- •Unstable Medical Condition(s).
- •Pregnancy or Breastfeeding.
- •Contraindication to MRI (e.g. Ferrometallic Implant or Claustrophobic Anxiety).
- •Concurrent Enrollment in Another Clinical Trial.
- •Significant Risk of Protocol Non-Adherence (e.g. resides > 50 miles from the hospital, and has no automobile or alternate transportation).
研究组 & 干预措施
Uridine
Subjects randomized to this study arm will receive uridine 2000 mg daily by mouth for 4 weeks
干预措施: Uridine (Drug)
Placebo
Subjects randomized to this arm of the study will receive placebo 2000 mg daily by mouth for 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Beck Scale for Suicide Ideation (BSSI)
时间窗: 4 weeks
The hypothesis is that 4 weeks of uridine 2000 mg daily will decrease the probability and severity of suicidal ideation measured with the BSSI compared with placebo. The BSSI is a 19 item measure on a 0-2 point scale for a range of 0-38, with higher scores indicating higher suicidal ideation or worse outcomes.
Change From Baseline in Brain Gamma-Aminobutyric Acid (GABA)/NAA Levels, Measured With Proton-1 Magnetic Resonance Spectroscopy (1H-MRS) Neuroimaging
时间窗: 1 week
The hypothesis is that Brain Gamma-Aminobutyric Acid (GABA)/NAA levels will show a greater increase after 1 week, in uridine-treated vs. placebo-treated veterans with suicidal ideation. Proton-1 Magnetic Resonance Spectroscopy (1H-MRS) is a safe and non-invasive method for in-vivo measurement of brain chemistry relevant to mental health, including the neurotransmitters, glutamate, glutamine, and GABA.
Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: 4 weeks
The hypothesis is that 4 weeks of uridine 2000 mg daily will decrease the probability and severity of suicidal ideation measured with the C-SSRS, compared with placebo. Scores range from 0 to 25 with higher scores representing more severe suicidal ideation.
次要结局
- Change From Baseline in Brain Total Choline/N-acetylaspartate (NAA) Levels, Measured With Proton-1 Magnetic Resonance Spectroscopy (1H-MRS) Neuroimaging(1 week)