NK1 Antagonists for Pathological Aggression: A Protocol for Harmful, Impulsive, and Self-/Aggressive Behavior (AHIMSA-1) Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Modified Overt Aggression Scale
研究概览
简要总结
Neurokinin (NK) -1 antagonist will be administered to study patients in a double-blind placebo trial. Patients receive assessments including Anger Disorder Scale (ADS) and Modified Overt Aggression Scale (MOAS) and perform computerized study tasks during MRI before the trial begins. Patients receive either one week of the drug or one week of placebo and perform the same tasks and assessments. Then patients receive another week of the alternate pill, followed by another round of tasks during MRI and assessments.
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
- •are outpatients between 18 and 65 years old inclusive
- •meet diagnostic criteria for either Intermittent Explosive Disorder or the adult-modified criteria for Disruptive Mood Dysregulation Disorder (Appendix A)
- •have maintained a stable regimen of psychotropic medications (antidepressants, antipsychotics, anticonvulsants, and anxiolytics) for at least 4 weeks prior to study enrolment and throughout the duration of the treatment phase of the study
- •If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
- •Have capacity with respect to medical decision-making and consent to participate
- •pass the TMS Assessment Safety Survey (TASS) MRI safety questionnaire
排除标准
- •have a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or other primary psychotic disorder
- •meet criteria for a current manic episode or hypomanic episode
- •have a diagnosis of dementia or other neurodegenerative illness affecting the central nervous system
- •have a history of substance dependence or abuse within the last 3 months
- •are pregnant or currently nursing*
- •*Patients will be tested before and after the study with a urine pregnancy test.
- •are taking contraindicated or interacting medications from product monograph of aprepitant
- •have an implanted intracranial device or pacemaker
- •have a diagnosis of severe hepatic insufficiency
研究组 & 干预措施
Active/Placebo crossover
NK1 Antagonist 7 days followed by placebo 7 days.
干预措施: NK1 Antagonist (Drug)
Active/Placebo crossover
NK1 Antagonist 7 days followed by placebo 7 days.
干预措施: Placebo Oral Capsule (Drug)
Placebo/Active Crossover
Placebo for 7 days followed by NK1 Antagonist 7 days.
干预措施: NK1 Antagonist (Drug)
Placebo/Active Crossover
Placebo for 7 days followed by NK1 Antagonist 7 days.
干预措施: Placebo Oral Capsule (Drug)
结局指标
主要结局
Change in Modified Overt Aggression Scale
时间窗: 1 week
次要结局
- Change in Ball passing task(1 week)
- Change in Point Subtraction Aggression Task (PSAT)(1 week)
- Change in Anger Disorders Scale (ADS)(1 week)
- Change in Buss-Perry Aggression Questionniare (BPAQ)(1 week)
- Change in State-Trait Anger Expression Inventory(1 week)
研究者
Gary Chaimowitz
Local Primary Investigator, Head of Forensics
St. Joseph's Healthcare Hamilton