NCT01158547已完成不适用
A Pilot Placebo Controlled, Double-Blind, Randomized Parallel Group Study to Evaluate the Efficacy of Treatment With CLR3001 in Depression
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Clera Inc.
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Efficacy using Hamilton Rating Scale for Depression
研究概览
简要总结
The purpose of this study is to assess the ability of CLR3001 to reverse depressive symptoms relatively quickly in adult patients with major depressive disorder (MDD).
详细描述
CLR3001 is thought to work by helping the body's natural responses overcome depression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 out-subjects 18-65 years.
- •Single episode or recurrent MDD (to a maximum of 5 prior episodes).
- •No current therapy for depression as per washout instructions.
- •Able to provide written informed consent.
- •Meet criteria for MDD with current MDE through MINI questionnaire.
- •Meet criteria for MDD with current MDE, as defined by DSM-IV TR.
- •HAMD-17 score ≥ 14 at screening (visit 1) and baseline (Visit 2; Randomization).
- •Able to understand and complete questionnaires, and communicate with the investigator and study coordinator.
- •Judged to be reliable to keep all appointments and procedures required by the protocol.
- •Female subjects of childbearing potential (who are not at least 2 years postmenopausal or surgically sterile or totally abstinent) must be using a reliable, medically acceptable form of contraception and must agree to continue such use throughout the duration of the study. Reliable forms of contraception include oral, implanted, transdermal or injected contraceptives, intrauterine devices, and adequate double barrier methods including use of spermicide. Partner's vasectomy is also an acceptable contraceptive regimen.
排除标准
- •Investigators and immediate family members.
- •Treatment within the last 90 days with a drug that had not received regulatory approval at the time of study entry.
- •Persons who had previously withdrawn from this study or previous study investigating CLR
- •A primary diagnosis of Panic Disorder, Social Anxiety Disorder, Obsessive-Compulsive Disorder within the past year.
- •The presence of an Axis II disorder, which, in the opinion of the investigator, would interfere with compliance in the study.
- •History of active substance dependence within the last half-year, excluding nicotine and coffee, or active substance abuse that may interfere with the outcome of the study.
- •Acute suicidal ideation or risk, ≥3 on HAMD-17 suicide item.
- •Fall in HAMD-17 score greater than 20% between Visit 1 and Visit
- •Serious concomitant diseases such as cancer, serious metabolic (e.g. Insulin dependent diabetes), renal, cardiac, thyroid, immunological, neurological or other significant disease or laboratory abnormality (hematology, blood chemistry, ECG), or treatment for medical conditions which may interact with CLR
- •Women who are pregnant or breast-feeding, or men or women who plan to
- •Infirmities or living in an area limiting participation in the study or compliance with study procedures.
结局指标
主要结局
Efficacy using Hamilton Rating Scale for Depression
时间窗: Weeks 2 to 7
次要结局
未报告次要终点
研究者
研究点 (1)
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