Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Quick Inventory of Depressive Symptomatology - Clinician Version (QIDS-C)
研究概览
简要总结
The study is a 6-week, proof-of-concept, open trial of vortioxetine for 20 patients with major depressive disorder.
详细描述
The U.S. Food and Drug Administration approved vortioxetine to treat major depressive disorder in 2013. Researchers believe vortioxetine may improve pattern separation and pattern completion (i.e., a neurological function) in people with major depressive disorder; thus, this research study aims to determine how vortioxetine increases a person's ability to think. The current study is an open label trial, therefore, all participants will receive vortioxetine. Furthermore, participants receive the vortioxetine at no cost. It will take participants 6 weeks to complete this study. Participants are asked to come to the Mass General Hospital campus for 1 screening visit which includes a full psychiatric evaluation, and 5 additional study visits. During study visits, participants will meet with a clinician and then complete computer based cognitive tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Meets Diagnostic and Statistical Manual of Mental Disorders (Versions 4 and 5) criteria for and Major Depressive Disorder.
- •Hamilton Depression Rating Scale-17 score greater than
- •Men and women between ages >=18 and 65.
排除标准
- •Meets Diagnostic and Statistical Manual of Mental Disorders (versions 4 and 5) criteria for schizophrenia, schizoaffective disorder, obsessive compulsive disorder.
- •Unable to follow instructions or otherwise unable to participate in the trial.
- •Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, partner with vasectomy)
- •Patients who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk.
- •Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease.
- •History of seizure disorder.
- •The following Diagnostic and Statistical Manual of Mental Disorders (Version 4) diagnoses (any current or past history, except substance abuse disorders):
- •Organic mental disorders, schizoaffective disorder, delusional disorder, psychotic disorders not elsewhere classified.
- •History of multiple adverse drug reactions or allergy to the study drugs.
- •Patients with mood congruent or mood incongruent psychotic features
- •Current use of other psychotropic drugs.
- •Clinical or laboratory evidence of hypothyroidism.
- •Patients who have failed to respond during the course of their current major depressive episode to at least one adequate antidepressant trial, defined as six weeks or more of treatment with citalopram 40 mg/day (or its antidepressant equivalent)
- •Patients who have had electroconvulsive therapy within the 6 months preceding baseline.
- •Concomitant use of serotonergic agents
- •Meets Diagnostic and Statistical Manual of Mental Disorders (versions 4 and 5) criteria for bipolar disorder
研究组 & 干预措施
Study Phase
During this phase participants receive open label vortioxetine for 6 weeks. Participants come to the Depression Clinical & Research Program at the Massachusetts General Hospital for visits once a week. During these visits the participants meet with clinicians and complete cognitive tasks.
干预措施: Vortioxetine (Drug)
结局指标
主要结局
Quick Inventory of Depressive Symptomatology - Clinician Version (QIDS-C)
时间窗: 6 weeks
This scale is designed to assess the severity of depressive symptoms. The minimum score is a 0 (zero) and the maximum score is a 27, and a higher score means a worse outcome.
次要结局
- Digital Symbol Substitution Test(6 weeks)
- Rey Auditory Verbal Learning Test(6 weeks)
研究者
Andrew A. Nierenberg, MD
Director, Bipolar Clinic and Research Program; Associate Director, Depression Clinical and Research Program; Director, Clinical Research Support Office, Clinical Research Program
Massachusetts General Hospital