EUCTR2012-004062-17-GR进行中（未招募）1 期
Efficacy of add-on pregabalin in the treatment of Generalized Anxiety Disorder comorbid with Major Depressive Disorder: a double-blind placebo-controlled study.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Generalized Anxiety Disorder (GAD) according to DSM-IV-TR diagnostic criteria
- •2. Major Depressive episode (MD) according to DSM-IV-TR diagnostic criteria
- •3. Patients already receiving esitalopram.
- •4. Male or female patients, aged between 18-65 years of age
- •5. Signed and dated patients’ informed consent received from patients who are able to understand and comply with study requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any other comorbid condition
- •2. Abuse of alcohol or other substances at screening (excepting dependence being in total remission; excepting dependence on caffeine or nicotine), according to DSM-IV criteria
- •3. Abuse of substances such as opiates, amphetamines, barbiturates, cocaine, cannabis, hallucinogens for a duration of four weeks before screening day, according to DSM-IV criteria
- •4. Any DSM-IV-TR-defined psychic disorder that may affect the interpretation of results
- •5. Female patients of reproductive age who do not apply any reliable contraceptive method and do not have a negative human chorionic gonadotropin (HCG) value at screening
- •6. Patients who are in severe danger of suicide, or represent a danger to themselves and others in the investigator’s judgment
- •7. Known hypersensitivity or lack of responsiveness to the trial drugs in the investigator’s judgment.
研究者
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