Repeated Sub-anesthetic Ketamine to Enhance Prolonged Exposure Therapy in Post-traumatic Stress Disorder: A Proof-of-concept Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Severity of Post-traumatic Stress Disorder (PTSD) Symptoms
研究概览
简要总结
This study aims at investigating the effectiveness of the drug, Ketamine, in combination with Prolonged Exposure (PE) therapy for people suffering from PTSD. Participation in the study includes Ketamine infusions, which occur once a week for three weeks. PE therapy sessions will be scheduled one day after each infusion, and may continue up to 12 weeks. After completely therapy, there will be two monthly follow-up assessment visits.
详细描述
Study location: Minneapolis VA Medical Center
The study is an open-label interventional study designed to inform and strengthen the feasibility of protocol implementation on sub-anesthetic doses of intravenous Ketamine as augmenting strategy of standardized, manually-driven Prolonged Exposure therapy in PTSD.
Timeline: Eligible individuals can expect their participation to last up to 5 months. Compensation will be given for participation per session that is attended. Potential participants will be provided with information about the study and asked a series of questions to determine if they meet basic inclusion/exclusion criteria (e.g., indicators of current PTSD). They will be informed that the treatment involves multiple infusions of sedatives at subanesthetic doses followed by PE therapy. Those interested will be scheduled for an in-person, baseline session.
Voluntary informed consent will be obtained in accordance with local IRB approvals. During the baseline, all assessments, computer tasks, and information on treatment will be explained. Participants will also undergo a urine toxicology analysis during this session. Ketamine infusions and PE therapy appointments will be scheduled within two weeks of the baseline.
The day of the infusion, patients will arrive in the morning after an overnight fast of at least 8 hours. An IV will be placed in the non-dominant arm for medication administration. Vitals will be recorded throughout the entire medication treatment. Subjects will then receive IV infusion of 0.5mg/Kg of ketamine hydrochloride solution over 40 minutes. The dose of ketamine will be calculated by ideal body weight. Any altered sensory or dissociative effects will be measured before and after each infusion. Vitals will be monitored for another hour, until all side-effects have subsided. Participants are required not to drive or use heavy machinery until the following morning.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic (minimum of three months) PTSD (Clinician-Administered PTSD Scale for DSM-5 -CAPS-5 score>33).
- •Voluntarily eligible to participate in PE.
- •Severity of PTSD symptoms defined by PCL-5>
- •Psychotropic medications on stable doses (no dosing adjustments/changes for ≥4 weeks; ≥6 weeks for fluoxetine) prior to prior to beginning of the study.
排除标准
- •Unwillingness/unable to sign informed consent.
- •Previous or current participation in trauma-exposed therapy and/or ketamine treatment.
- •Evidence of mental retardation, pervasive developmental disorder and/or moderate/severe cognitive impairment (MMSE scores ≤27).
- •Any unstable medical or non-psychiatric CNS condition.
- •Lifetime history of psychosis-related disorder, bipolar disorder I or II disorder, or any condition other than PTSD judged to be the primary presenting psychiatric diagnosis.
- •Moderate to severe traumatic brain injury (mental status change or loss of consciousness>30 min; Glasgow Coma Scale <13; post-traumatic amnesia>24hours; visible lesion on CT/MRI brain scan).
- •Active alcohol/illicit substance use disorder within 6 months of initial assessment; presence of illicit drugs by positive urine toxicology.
- •For women: pregnancy (confirmed by lab test), initiation of female hormonal treatments within 3 months of screening, or inability/ unwillingness to use a medically accepted contraceptive method during the study.
- •Imminent risk of suicidal/homicidal ideation and/or behavior with intent and/or plan
研究组 & 干预措施
Ketamine and PE
ketamine treatment followed by a standardized prolonged exposure session for the first 3 weeks; then, weekly prolonged exposure as usual.
干预措施: ketamine-enhanced prolonged exposure (Drug)
结局指标
主要结局
Change in Severity of Post-traumatic Stress Disorder (PTSD) Symptoms
时间窗: 10 weeks
The overall severity of PTSD symptoms would be measured by the mean change in the Past Month (current) total scores on the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (CAPS-5) from baseline to post-treatment (10 weeks). The CAPS-5 is a structured interview with higher values representing worse outcomes. The CAPS-5 total symptom severity score ranges from 0 to 80 and it is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms.
次要结局
- Change in PTSD Symptoms for DSM-5(10 weeks)
- Change in Severity of Depressive Symptoms(10 weeks)
研究者
Paulo Shiroma
Clinical Investigator
Minneapolis Veterans Affairs Medical Center