Orexin Antagonism to Target Mechanisms of Suicide Risk: A Proof-of-Concept Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Implicit Association Tests (IATs)
研究概览
简要总结
The goal of this proof-of-concept clinical trial is to evaluate the initial safety, feasibility, and tolerability of the orexin mixed antagonist suvorexant in a sample of veteran adults with Major Depressive Disorder and elevated suicide risk. The main question it aims to answer is: Is Suvorexant safe, feasible, and tolerable for participants?
Participants will:
- Take Surovexant every day for four weeks (10mg in the first two weeks and 20mg in the second two weeks)
- Visit the medical center at the beginning of the study (week 1), after taking Suvorexant for two weeks (week 3) and following the full Suvorexant dose (week 5) for in-person assessments.
- Fill out self-report assessments (remotely) at week 2 (after one week of Suvorexant) and week 4 (after three weeks of Surovexant)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age (up to 70 years)
- •Primary diagnosis of Major Depressive Disorder as determined by the study psychiatrist and confirmed by the Mini-International Neuropsychiatric Interview (MINI)
- •Lifetime suicide attempt history and suicidal ideation at baseline as determined by a score ≥2 on the Columbia-Suicide Severity Rating Scale (C-SSRS)
排除标准
- •Clinically significant medical or neurological condition
- •Current use of strong CYP3A live enzymes or moderate CYP3A inhibitors or strong CYP3A inducers
- •Current use of digoxin
- •Currently pregnant, not using contraception, nursing, or trying to become pregnant
- •Active substance use disorder in the last six months, disorder, or current or past psychotic disorder, bipolar disorder, or obsessive-compulsive disorder
- •Severe traumatic brain injury
- •Imminent suicidal or homicidal risk
- •Free of unstable medical conditions or any contraindication to suvorexant (per FDA prescribing label) as determined by patient interview and review of available medical records.
研究组 & 干预措施
Suvorexant group
Veteran patients with Major Depressive Disorder and elevated risk of suicide will receive the FDA-approved drug Suvorexant (brand name: Belsomra), a mixed Orexin antagonist, for four weeks. Participants will take 10mg of Surovexant nightly for the first two weeks and 20mg of Surovexant nightly for the second two weeks.
干预措施: Suvorexant (dual orexin receptor antagonist) (Drug)
结局指标
主要结局
Implicit Association Tests (IATs)
时间窗: Weeks 1, 3, and 5
Implicit Association Tests ( IATs) use reaction time (RT) to capture automatic, implicit processes to gauge implicit self-identification with a construct of interest. Participants classify stimuli presented in the center of the screen into categories. The category labels are located on the left and right of the screen and participants classify stimuli by selecting keys corresponding to the left or right. RTs are measured as participants complete this task thereby gauging implicit mental associations. This study uses two variations of the IAT, a suicide-related IAT and a Escape-Me IAT to determine the extent to which participants associate suicide-related and escape-related constructs with the self.
次要结局
- Buss-Perry Aggression Questionnaire(Weeks 1, 2, 3, 4, and 5)
- Overt Aggression Scale Modified(Weeks 1, 2, 3, 4, and 5)
- Point Subtraction Aggression Paradigm(Weeks 1, 3, and 5)
- Barratt Impulsiveness Scale(Weeks 1, 2, 3, 4, and 5)
- Beck Scale for Suicidal Ideation(Weeks 1, 2, 3, 4, and 5)
- Columbia Suicide Severity Rating Scale(Weeks 1, 2, 3, 4, and 5)
- Gradual-Onset Continuous Performance Task(Weeks 1, 3, 5)
- Emotional Gradual Onset Continuous Performance Task(Weeks 1, 3, and 5)
研究者
Marianne Goodman
Psychiatrist; VISN 2 MIRECC Director
Bronx Veterans Medical Research Foundation, Inc