EUCTR2020-000784-23-DE进行中（未招募）1 期
The effects of esketamine and treatment expectation in acute major depressive disorder: a pharmacological fMRI-study (Expect)
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
- 176
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.a current depressive episode lasting at least four weeks
- •2.an initial score of at least 7 (corresponding to a mild degree of depression) on the Montgomery A°sberg Depression Rating Scale (MADRS)
- •3.Negative serum pregnancy test in women of childbearing potential.
- •4.Patients with reproductive potential must agree to maintain highly effective methods of contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study. If abstinence could not be practiced, a combination of hormonal contraceptive (oral, injectable, or implants) and a barrier method (condom, diaphragm with a vaginal spermicidal agent) has to be used.
- •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 176
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.psychotic symptoms (ascertained using SCID-5 Interview measured by module A-E)
- •2.acute suicidality (clinical assessment by study physician)
- •3.hypertension > 180/100 mmHg (according to resting blood pressure, as assessed by study physician using blood pressure measurement)
- •4.hyperthyroidism that has not been sufficiently treated (clinical history by study physician and current thyroid parameters will have to be within the following ranges: TSH 0,34-5,6 mU/l, fT3 3,2-6,9 pmol/l, fT4 7,5-21 pmol/l)
- •5.severe hepatic impairment (clinical history by study physician and current liver parameters will have to be within the following ranges: serum albumin < 2,8 g/dl serum bilirubin > 3,0mg/dl, prothrombin time < 40 % or INR > 2,3)
- •6.hypersensitivity to the active substance of esketamine or to any of the excipients listed in section 6.1 of the SmPC (clinical history by study physician)
- •7.unstable angina or myocardial infarction in the last 6 months (clinical history by study physician)
- •8.Myocardial failure (clinical history and physical examination by study physician)
- •9.Glaucoma or perforating eye injuries (clinical history by study physician)
- •10.patients will be excluded if they have any drug or alcohol dependency/abuse within the previous three months or if they are under acute influence of alcohol (clinical assessment by study physician and alcohol breath test)
- •11.any contraindications for MRI, i.e. non-removable medical devices (such as pacemakers, insulin pumps, implantable drug infusion pumps etc) or metal devices /foreign bodies (such as aneurysm clips, metal splinters in the eye , intrauterine devices etc) and pregnancy (clinical assessment by study physician and serum pregnancy test)
- •12.medical conditions likely to affect brain anatomy or physiology (clinical assessment by study physician)
- •13.age <18 or > 65 years
- •14.inability to provide written informed consent
- •15.Breastfeeding (clinical history by study physician)
- •16.simultaneous participation in other clinical trials if not permitted by the Principal Investigator
- •17.Patients for whom an elevated blood pressure or an increased intracranial pressure represents a serious risk will be excluded (clinical history and blood pressure measurement by study physician)
- •18.Patients with manifest ischemic heart diseases will be excluded (clinical history by study physician)
- •19.Increased intracranial pressure (clinical history by study physician)
- •20.Severe psychological disorders other than depression (Structured Clinical Interview for DSM-5 (SCID-5) measured by module A-E)
- •21.Concomitant therapy with Xanthin-derivates and ergometrin (clinical history by study physician)
- •22.Treatment with strong inhibitors or inducers of CYP3A4 (for example, but not exclusively, HIV protease inhibitors, Macrolide antibiotics, Azole antifungals, Carbamazepine, Phenobarbital; clinical history by study physician)
- •23.Diazepam treatment (clinical history by study physician)
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