A Pilot Study of Betahistine Dihydrochloride in the Treatment of Major Depression With Atypical Features
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Maximum Tolerable Dose of Betahistine Dihydrochloride in mg
研究概览
简要总结
The purpose of this study is to determine a dose of the investigational drug betahistine dihydrochloride that is both well tolerated and potentially effective in treating the symptoms of atypical depression. Atypical depression is characterized by the ability of the person's mood to improve temporarily in response to positive events, as well as features such as increased appetite, increased sleep and severe fatigue.
详细描述
All patients will start taking 50 mg of betahistine dihydrochloride on treatment day 1 (after baseline visit). Starting on day 4, the daily dose will be increased by adding a 50 mg dose. If tolerated, the daily dose will be titrated to 200 mg. At the end of week 3, the dose will be titrated to 300 mg.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have signed written informed consent
- •Be male and/or female outpatients 18 65 years of age, inclusive
- •For women: must be surgically sterile, 2 years postmenopausal, or, if they have childbearing potential, using a medically accepted method of birth control and agree to continue use of this method for at least 30 days after the last dose of study drug (i.e., barrier method with spermicide, steroidal contraceptive or intrauterine device [IUD])
- •Meet DSM IV1 criteria for major depressive episode (unipolar), with atypical features
- •Have a score of 20 or greater on the Hamilton Depression Rating, 28-item version (HAM-D-28)
- •Have a complete medical and psychiatric history, physical examination, laboratory evaluation, and ECG before study entry.
- •Have baseline laboratory values and ECG that are normal, or abnormalities that are clinically insignificant
排除标准
- •Have significant and/or unstable gastrointestinal, neurological, endocrine, cardiovascular, pulmonary, renal, hepatic, immunological or hematological disease; organic brain disease; or cancer as determined by history, physical, ECG, and laboratory examination
- •Have a history of peptic ulcer disease
- •Have a history of severe asthma
- •Have a current diagnosis of pheochromocytoma
- •Are pregnant, intending to become pregnant, nursing, at risk for pregnancy, or not practicing medically acceptable birth control. (A blood pregnancy test will be performed at the screening visit)
- •Meet criteria for DSM IV1 psychoactive substance abuse or dependence in the past month
- •Have a history of a psychotic disorder
- •Use any medications that, in the judgment of the investigator, might have psychotropic effects, or interact unfavorably with betahistine dihydrochloride including centrally acting antihistaminic agents
- •Have a history of hypersensitivity to betahistine dihydrochloride
- •Exhibit, or suggestion that they may display, behavior that will not be conducive to the study procedures
- •Are at significant risk of suicide as indicated by a score of 3 or greater on item number 11 on the HAM-D 28
- •Have received any investigational product within 28 days of Screening
- •Have used any antidepressant within 7 days of Screening (14 days for MAOIs; 21 days for fluoxetine)
研究组 & 干预措施
Arm 1: Betahistine dihydrochloride
Oral betahistine dihydrochloride; daily dose 50-300 mg
干预措施: betahistine dihydrochloride (Drug)
结局指标
主要结局
Maximum Tolerable Dose of Betahistine Dihydrochloride in mg
时间窗: 7 weeks
The highest betahistine dose that is well tolerated when patients are titrated from 50 mg to a maximum 300 mg of daily divided doses.
次要结局
未报告次要终点
研究者
Erik Nelson
Adjunct Associate Professor
University of Cincinnati