An Open-Label Clinical Trial of Simultaneous Administration of Oral Aspirin and Ketamine as Adjunct to Oral Antidepressant Therapy in Treatment-Resistant Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS).
研究概览
简要总结
The purpose of this study is to assess the effects of simultaneous administration of oral aspirin and oral ketamine as a therapeutic for those with Treatment Resistant Depression.
详细描述
The objective of the study is to evaluate the effect of simultaneous administration of oral aspirin and oral ketamine, formulated for partial release in the oral cavity and partially swallowed, as an adjunct to the oral antidepressant on depressive symptoms in patients suffering from Treatment Resistant Depression (TRD) in outpatient Psychiatric Clinic. Investigators will evaluate the effects of simultaneous administration of oral aspirin and oral ketamine, on depressive symptoms.
This is a prospective open-label, proof of concept clinical trial of simultaneous administration of proprietary formulations of oral aspirin and ketamine in medically stable adult patients with a diagnosis of Treatment Resistant Depression. All eligible participants will commit to three visits. The first two visits are in-person at the clinic for administration of oral ketamine and oral aspirin. Participants will be under observation for at least two hours. Study participant's vital signs will be monitored, periodically. The last visit will be conducted remotely.
Adult patients 18 years of age and older, with a diagnosis of TRD presenting to the psychiatric clinic will be screened for enrollment by study team.
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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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with Treatment Resistant Depression with Montgomery-Asberg Depression Rating Scale score >22 upon presentation to the clinic
- •Treatment Resistant Depression is defined as Major Depressive Disorder that does not cease after at least 6 week trial of another class of antidepressants
- •Unipolar Depression
排除标准
- •Adult patients with recent or current suicidal ideation with an intent to act, homicidal ideations with an intent to act
- •History of Bipolar Disorder, Obsessive Compulsive Disorder, antisocial personality disorder, borderline personality disorder, and congestive cardiac failure
- •Uncontrolled hypertension (BP >140 mm Hg systolic and/or >90 mm Hg diastolic on two separate readings at the time of screening) or on 2 medications for hypertension
- •Patients with unstable vital signs (systolic blood pressure <90 or>160 mm Hg, pulse rate <50 or >150 beats/min, and respiration rate <10 or >30 breaths/min),
- •History of Gastrointestinal hemorrhage, renal and hepatic insufficiency
- •Allergy to Ketamine or Aspirin
- •Active Substance Abuse Disorder
- •Active psychosis
- •Active Peptic Ulcer Disease
- •Lithium Therapy
- •Swallowing difficulty
- •Consumption of Aspirin or NSAID's within 6 hours of arrival to the site
- •Previous participation in this study; a patient may not re-enroll in another study while in this study
- •Pregnant or breastfeeding
研究组 & 干预措施
Intervention Group
All individuals 18 years old or older who have Major Depressive Disorder and have failed to achieve response or remission to at least one proven antidepressant trial with minimum affective dose for a duration of at least 6 weeks.
干预措施: VTS-K (Drug)
结局指标
主要结局
Change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS).
时间窗: 7 Days
Montgomery-Asberg Depression Rating Scale has a range from 0 to 60, where the lower score indicates the better health status. Change in mean total Montgomery Asberg Depression Rating Scale (MADRS) score from the baseline (pre-dose day 1 ) and on day 7
次要结局
- Clinician-Administered Dissociative States Scale (CADSS)(4 Days)
- Maximal sedative effects using Modified Observer's Assessment of Alertness and Sedation ( MOAA/S)(4 Days)
- A change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) from the baseline (pre-dose on day 1 and 4) and 2 hours post-medication administration(4 Days)
- Side Effect Rating Scale for Dissociative Anesthetics (SERSDA)(4 Days)
研究者
Theresa Jacob, PhD, MPH
Director of Research
Maimonides Medical Center