EUCTR2013-003370-27-DE进行中（未招募）1 期
Functional MRI (fMRI) after challenge and treatment with antidepressants and their relation to the clinical course, to the Hypothalamus-Hypophysis-Adrenocortical Axis and the colon microbiome - fMRI, HPA-axis and gut microbiome during treatment with antidepressants
Rainer Rupprecht, Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg am Bezirksklinikum0 个研究点目标入组 80 人开始时间: 2014年7月24日最近更新:
适应症
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
- 80
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
- •Male and female in-patients in the age between 18 and 65 years
- •Major depressive disorder
- •Admission on a voluntary basis independent of our study
- •Written informed consent for trial participation after the scope and nature of the investigation have been explained to the patients before starting trial-related activities.
- •Indication for antidepressant therapy independent of the clinical trial.
- •primary unipolar depression (ICD-10: F32, F33) or bipolar depression (ICD-10: F31.3-5), current episode of depressed state for at least 2 weeks prior to baseline
- •Physically healthy
- •Right handedness (assessed by the Edinburgh Handedness Inventory (Oldfield, 1971))
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Schizophrenia, substance dependence as define by ICD-10 or any other psychiatric primary diagnosis (according to the ICD-10 criteria)
- •major somatic or neurological disorder
- •abnormalities in the laboratory screening at baseline (e.g. hypo- or hyperthyroid state, elevated liver enzymes, blood cell dyscrasias)
- •lacking ability to give informed consent
- •have been admitted to the clinic involuntarily during their present episode
- •pregnancy or breast-feeding
- •in case of the inclusion of premenomausal female patients insufficient contraception leads to exclusion from the study
- •contraindications to magnetic resonance imaging patient with heart pacemaker or implanted metal in the scull
- •or concurrent medication, which could alter emotional processing
- •known history of alcohol or drug abuse during 6 month prior to the screening
- •being at clinically risk of suicidal behavior (HAM-D Item 3 > 2 or clinical impression)
- •involuntary admission to the hospital
- •known allergies or hypersensitivity reactions or other contraindications for escitalopram, agomelatin or mirtazapine
- •being treated with psychotropic medication < 3weeks before study (5weeks in case of fluoxetine pretreatment)
- •Unusual diets leading to malnutrition
- •Pretreatment with antibiotics or corticosteriods
研究者
相似试验
已完成
不适用
Functional MRI assessment of primary and secondary brain tumour response to radiation therapy: A pilot studyACTRN12616000863437Dr Eng-Siew Koh39
已完成
1 期
A functional MRI study focusing on the association between adenosine triphosphate and empathyDepressive symptomsJPRN-UMIN000036676Aichi Medical University School of Medicine40
已完成
不适用
sing functional magnetic resonance imaging to investigate the efficacy of menthol in chemotherapy induced peripheral neuropathy (CIPN)Chemotherapy Induced Peripheral Neuropathy (CIPN)CancerISRCTN69917256Academic and Clinical Centre Office for Research and Development (ACCORD) (UK)32
已完成
不适用
The study of functional magnetic resonance imaging for the evaluation of the neural basis of the symptoms and state of mental illness.healthy volunteer schizophrenia mood disorders neurotic disorders disorders of psychological development behavioural and emotional disordersJPRN-UMIN000010716ippon Medical School180
招募中
1 期
Clinical efficacy evaluation and RS-fMRI related mechanism of acupuncture at Xingan Yuyuan point in the treatment of insomnia of heart type caused by liver fireinsomniaITMCTR2200006819Yueyang Hospital of Integrated Traditional Chinese and Western Medicin, Shanghai University of Traditional Chinese Medicine