Intranasal Insulin for Treating Posttraumatic Stress Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in PTSD Symptoms on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) From Pre- to Post-Intervention
研究概览
简要总结
To evaluate if intranasal insulin is effective in reducing PTSD symptoms.
详细描述
The current proposal aims to study the pharmacotherapeutic effects of intranasal insulin on PTSD symptoms and inhibition of amygdala hyperactivation in subjects with PTSD.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 21-65 years old
- •Current PTSD
- •Able to provide written informed consent
排除标准
- •Unstable medical condition, clinically determined by a physician
- •Diabetes requiring insulin or oral hypoglycemic agents
- •Moderate-severe traumatic brain injury
- •Current psychotic disorder, bipolar disorder, cognitive disorder in the past 12 months
- •Current substance use disorders (except alcohol, tobacco, or cannabis) in the past 3 months
- •Changes in doses of psychotropic medications in the past 4 weeks
- •Initiation of individual therapy or counseling in the past 4 weeks
- •Imminent suicidal or homicidal risk
- •Contraindication to Insulin
- •History of claustrophobia
- •Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI safety screening questionnaire
研究组 & 干预措施
Intranasal insulin
Subjects in this arm will receive 40 IU of intranasal insulin twice a day (80 IU per day).
干预措施: Intranasal insulin (Drug)
Placebo
Subjects in this arm will receive placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in PTSD Symptoms on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) From Pre- to Post-Intervention
时间窗: 1 week
The five-point CAPS-5 consists of 20 PTSD symptoms rated on a 0-4 scale (total range: 0-80) as follows: (1) 5 Intrusion symptoms (0-20), (2) 2 Avoidance symptoms (0-8), (3) 7 Cognitions and mood symptoms (0-28), and (4) 6 Arousal and reactivity symptoms (0-24). Higher scores represent a worse outcome (i.e., more PTSD symptoms). Findings are reported as change scores. For the medication group: CAPS score changes = CAPS score after taking medication for 1 week - CAPS score just before taking medication. For the placebo group: CAPS score changes = CAPS score after taking placebo for 1 week - CAPS score just before taking placebo. A negative value indicates a reduction in symptom severity.
次要结局
未报告次要终点
研究者
Gihyun Yoon, MD
Principal Investigator
VA Connecticut Healthcare System