EUCTR2017-000990-35-IT进行中（未招募）1 期
EFFECTS OF ANTIDEPRESSANT TREATMENT WITH AGOMELATINE ON PATIENTS AFFECTED BY DEPRESSION AND EPILEPSY. A DOUBLE BLIND RANDOMIZED STUDY WITH ACTIVE CONTROL (ESCITALOPRAM) WITH PARALLEL GROUPS. - DeprEpil
DIP. MEDICINA DEI SISTEMI UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATA0 个研究点目标入组 208 人开始时间: 2020年1月14日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 208
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
入选标准
- •1.Definite diagnosis of epilepsy and antiepileptic medication for more than 6 months;
- •2.Age 40-75;
- •3.Beck Depression Inventory –II score >14
- •4.No previous utilization of any antidepressant agent;
- •5.Able to co-operate and understand written and oral information;
- •6.Signed written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 134
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 88
排除标准
- •1.Patients with hypersensitivity to the Agomelatine and/or Escitalopram;
- •2.Psychiatric disorders other than depression;
- •3.Participation in other clinical trials within the last six months prior to inclusion in the present study;
- •4.Unable to take part in the study as a whole;
- •5.Use of drugs interfering with CNS other than AEDs;
- •6.History of pseudoseizures, status epilepticus during the previous year;
- •7.Alterations of blood tests that might interfere with the participation and/or completion of the study by the patient;
- •8.Patients with hepatic injury, or with transaminases levels three times the upper limit of normal (ULN), or hepatic risk factors such as obesity/overweight/non-alcoholic fatty liver disease, diabetes, substantial alcohol intake or concomitant medicinal products associated with risk of hepatic injury.
- •9.Concomitant treatment based on strong CYP1A2 inhibitors;
- •10.Women of childbearing potential who are not using effective contraception;
- •11.Women with suspected or confirmed pregnancy and breastfeeding;
- •12.Concomitant hormonal therapy;
- •13.QTc interval>450 msec.
研究者
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