Functional Magnetic Resonance Imaging of Patients Receiving Intravenous Ketamine for Treatment Resistant Bipolar Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Acute Response Changes in Subgenual Cingulate Functional Connectivity
研究概览
简要总结
This is a prospective open-label observational study of patients with treatment resistant bipolar depression referred for intravenous ketamine, with an interventional component of fMRI.
详细描述
This is a prospective open-label observational study of patients with treatment resistant bipolar depression referred for intravenous ketamine. All participants will receive an acute series of ketamine consisting of twice weekly infusions over three weeks. Non-responders will have their End of Study visits within 5 days of the last ketamine infusion. Responders (participants who achieve a greater than or equal to 50% decrease on their QIDS-SR-16 score from Baseline) will return for three weeks of continuation treatment (weekly ketamine) and then have their End of Study visit within 5 days of the last continuation treatment. All participants will undergo fMRI the prior to their first ketamine infusion, and after completion of their acute series.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Written informed consent before any study related procedures are performed
- •Males/females at least 18 years of age but no older than 75 years of age
- •Meet DSM-5 criteria for a current Major Depressive Episode and lifetime Bipolar I disorder or Bipolar II disorder as determined by both:
- •A. a clinician's diagnostic evaluation and B. confirmed with the MINI International Neuropsychiatric Interview (MINI 7.0.2)
- •A current depressive episode that has lasted a minimum of 4 weeks as determined by both:
- •A. a clinician's diagnostic evaluation and B. confirmed with the MINI International Neuropsychiatric Interview (MINI 7.0.2)
- •Meet all the following criteria on symptom rating scales at screening:
- •A. Montgomery Asberg Depression Rating Scale (MADRS) score ≥20 B. Young Mania Rating Scale (YMRS) score of ≤ 5 C. QIDS-SR-16 score of ≥ 11
- •Have had ≥ 2 adequate trials of mood stabilizers, antipsychotics (only those FDA approved for bipolar depression), or antidepressants or augmentation strategies during their lifetime. An adequate trial is defined as 4 weeks of medication at the minimum FDA approved dose.
- •In the opinion of the investigator, the patient is willing and able to comply with scheduled visits, treatment plan, and other trial procedures for the duration of the study.
排除标准
- •Meet DSM-5 criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, or pervasive developmental disorder
- •Meets any exclusion criteria for ketamine treatment (uncontrolled arterial hypertension, uncontrolled hyperthyroidism, severe ischemic heart disease or heart failure, severe liver or kidney disease, space occupying lesion in the brain or the spinal cord, and uncontrolled glaucoma)
- •The patient is pregnant or breast feeding
- •The patient has a severe medical illness or severe neurological disorder
- •The patient has a known ketamine allergy or is taking a medication that may significantly interact with ketamine (see Appendix)
- •Diagnosis of psychotic features during the current depressive episode or within the past 6 months
- •Was previously enrolled in the trial
- •Active moderate or severe substance use disorder within the last 3 months (no exclusion for tobacco use disorder of any severity)
- •Current episode of mania/hypomania or mixed episode according to MINI or study clinician
- •MRI contraindications
- •Severe head trauma
- •Claustrophobia incompatible with scanning
- •Cardiac pacemaker
- •Implanted cardiac defibrillator
- •Aneurysm brain clip
- •Inner ear implant
- •Prior history as a metal worker and/or certain metallic objects in the body -- must complete MRI screening form and be approved by MRI technologist before each scan
- •History of clinically significant vertigo middle ear disorder, or double vision
研究组 & 干预措施
Open-label Ketamine TRBD
Outpatients with treatment resistant bipolar depression referred by their clinical providers for intravenous ketamine treatment
干预措施: Ketamine (Drug)
Open-label Ketamine TRBD
Outpatients with treatment resistant bipolar depression referred by their clinical providers for intravenous ketamine treatment
干预措施: Functional magnetic resonance imaging (fMRI) (Other)
结局指标
主要结局
Acute Response Changes in Subgenual Cingulate Functional Connectivity
时间窗: Three weeks after treatment initiation
Seed-to-whole brain functional connectivity z-maps will be calculated from the left and right subgenual cingulate on the baseline and post-acute resting-state functional MRI (rs-fMRI) from each participant. After acute treatment, participants will be categorized as "responders" (≥50% decrease from baseline score of Quick Inventory of Depressive Symptomatology 16-item self-report, QIDS-SR-16) or "non-responders". Brain regions in responders that exhibit significantly different treatment-related change in functional connectivity compared to non-responders will be identified using general linear model methods.
次要结局
- Acute Response Baseline Structural Connectivity(Three weeks after treatment initiation)
- Sustained Response Changes in Subgenual Cingulate Functional Connectivity(Six weeks after treatment initiation)
- Suicidal Ideation Changes in Subgenual Cingulate Functional Connectivity(Six weeks after treatment initiation)
研究者
Brian Barnett
Staff Physician
The Cleveland Clinic