KCT0000995已完成未知
Y2216684 Compared to Placebo as Adjunctive Therapy to SSRI in the Prevention of Symptom Reemergence in Major Depressive Disorder
Eli Lilly Korea0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •[1] Meet criteria for primary MDD, as defined by DSM-IV-TR criteria, as determined by clinical assessment and confirmed by the MINI at Visit 1.
- •[2] Are adult male or female outpatients at least 18 years of age or older at the time of informed consent, who provide informed consent by signing the appropriate ICFs. Patients must be competent and able to give their own informed consent.
- •[3] Women of child-bearing potential may participate in the study. Females of childbearing potential must:
- •a) test negative for pregnancy at Visit 1 based on a serum pregnancy test, and
- •b) agree to use a reliable method of birth control (for example, use of oral contraceptives or Norplant®; a reliable barrier method of birth control [diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, intrauterine devices]; partner with vasectomy; or abstinence) during the study and for 1 month following the last dose of study drug.
- •Females of childbearing potential are those not surgically sterilized and between menarche and 1-year postmenopausal (2-years postmenopausal if <50 years of age).
- •Men participating agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
- •[4] Are being treated with 1 of the following SSRIs that have been approved for MDD treatment within the participating country: escitalopram, citalopram, sertraline, fluoxetine, paroxetine, and fluvoxamine; and have been treated with their SSRI for at least 8 weeks prior to Visit 2 and with at least the last 4 consecutive weeks at a stable optimized dose prior to Visit 2. The SSRI prescribed, including dose, should be consistent with labeling guidelines within the participating country.
- •[5] Meet criteria for partial response at Visit 1 and Visit 2, as defined by investigator’s opinion that the patient has experienced a minimally clinically meaningful improvement with the SSRI treatment.
排除标准
- •[1] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- •[2] Are Lilly employees (that is, employees, temporary contract workers, or designees responsible for the conduct of the study).
- •[3] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this.
- •[4] Have previously completed or withdrawn from this study or any other study investigating LY2216684.
- •[5] Have had or currently have any additional ongoing DSM-IV-TR Axis I condition other than MDD that was considered the primary diagnosis within 1 year of Visit 1.
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