NCT01768767撤回2 期
Novel Approach of Combined Lithium-Ketamine Therapy in Bipolar Depression: To Preserve Efficacy and Minimize Adverse Effects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
This study is looking at the safety and efficacy of combined ketamine and lithium therapy for treating patients with bipolar depression who are taking a mood stabilizer that is not working for them.
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
- •Male or female between the ages of 18-65 years. Females will be included if they are not pregnant and agreed to utilize a medically accepted birth control method (to include oral, injectable, or implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy) or if post-menopausal for at least 1 year, or surgically sterile.
- •Able to provide written informed consent according to Yale HIC guidelines.
- •Bipolar Disorder in Major Depressive Episode (296.5x or 296.89), as determined by the Structured Clinical Interview for DSM-IV (SCID) patient edition 80
- •Montgomery Asberg Depression Rating Scale (MADRS) score of 18 or higher.
- •Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR16) score of 19 or higher.
- •Be able to understand and speak English.
排除标准
- •Patients with a history of DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder or currently exhibiting psychotic features associated with their depression.
- •Patients with current hypomanic and/or manic symptoms meeting DSM-IV-TR criteria of mixed episode are excluded.
- •DSM IV-TR Axis I disorders are excluded if they are considered primary disorders.
- •Dementia or suspicion thereof, is also exclusionary.
- •Serious suicide or homicide risk, as assessed by evaluating clinician; A serious suicide risk will be considered an inability to control suicide attempts, imminent risk of suicide in the investigator's judgment, or a history of serious suicidal behavior, which is defined using the Columbia-Suicide Severity Rating Scale (C-SSRS) as either (1) one or more actual suicide attempts in the 3 years before study entry with the lethality rated at 3 or higher, or (2) one or more interrupted suicide attempts with a potential lethality judged to result in serious injury or death.
- •Substance abuse or dependence during the 3 months prior to screening.
- •History of serious medical or neurological illness.
- •Signs of major medical or neurological illness on examination or as a result of a 12 lead ECG screening or laboratory studies.
- •Abnormality on physical examination. A subject with a clinical abnormality may be included only if the study physician considers the abnormality will not introduce additional risk factors and will not interfere with the study procedure.
- •Positive urine drug screen.
- •Pregnant or lactating women or a positive urine pregnancy test; for women of childbearing potential.
- •Subjects who test positive for HIV or viral hepatitis (hepatitis B and/or C) will be excluded as a means to (1) protect the subjects and research staff from the increased risks of blood borne pathogen transmission during placebo/ketamine infusions and (2) to minimize the factors which might influence the biochemical responses and affect the study outcome. This test will take place at the screening visit. Subjects will be invited back to the Yale Depression Research Program, either for their next study visit or for a HIV/Hep debriefing session. HIV results will be given in a face to face meeting no matter what the results are.
- •Patients requiring excluded medications (see Table 3 for details).
- •History indicating learning disability or mental retardation.
- •Known sensitivity to ketamine or lithium.
- •Resting blood pressure lower than 90/60 or higher than 150/90,or resting heart rate lower than 50/min or higher than 100/min.
研究组 & 干预措施
Ketamine/Lithium
Experimental
Participant will receive ketamine/lithium
干预措施: Ketamine/Lithium (Drug)
Ketamine
Active Comparator
Participant will receive ketamine
干预措施: Ketamine (Drug)
Placebo
Placebo Comparator
Participant will receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: 4 Hours to 2 weeks
次要结局
- Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR)(4 hours to 2 weeks)
- Clinical Global Impressions Scale (CGI)(4 hours to 2 weeks)
研究者
相似试验
已完成
2 期
Ketamine Plus Lithium in Treatment-Resistant DepressionDepressionNCT01880593Icahn School of Medicine at Mount Sinai34
已完成
不适用
Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain ConditionsChronic PainNCT05103319University Hospital, Basel, Switzerland319
终止
4 期
Ketamine-assisted Therapy for Advanced GI CancerPancreatic Ductal AdenocarcinomaPain, AcuteGastrointestinal CancersDemoralizationNCT06077487Brian Anderson, MD1
终止
2 期
KAP for Depression in Abstinent Opioid UsersOpioid Use Disorder, Severe, in Sustained RemissionOpioid Use Disorder, Severe, in Early RemissionMajor Depressive DisorderNCT05193318Medical University of South Carolina5
已完成
3 期
Ketamine Versus Co-administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency DepartmentProcedural Sedation and AnalgesiaNCT01387139University of Colorado, Denver183