EUCTR2018-001212-30-DE进行中（未招募）1 期
A trial to study effects of a single dose Citalopram on emotion processing in female patients with Borderline Personality Disorder and the associated modulation of fMRI BOLD signals
Central Institute of Mental Health, represented by commercial and administrative Director0 个研究点目标入组 30 人开始时间: 2018年7月23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
- 30
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
- •?Healthy, female, aged 18-45 years
- •?Diagnosis of Borderline Personality Disorder according to DSM-IV
- •?Use of adequate contraception
- •?Fluent German speaker and capable of completing the fMRI and behavioural tasks
- •?Signed written informed consent prior to the first study related procedure
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •?A history of alcohol or substance dependence within last 12 months prior to Visit 1
- •?A positive urine drug screen at Visit 1 (one re-test permitted within 1-3 days)
- •?A positive alcohol breath test at Visit 1
- •?A positive pregnancy test at visit 1
- •?Currently pregnant or trying to get pregnant or currently breast feeding
- •?Consumption of large amounts of caffeinated drinks (> 8 cups of standard caffeinated drinks or > 6 cups of stronger coffee or other drinks containing methylxanthines such as coca cola or Red Bull per day)
- •? Blood pressure outside normotensive range (systolic: 90 - 150 mm Hg, diastolic: 60 - 90 mm Hg ) at Visit 1
- •? Heart rate = 50 beats per minute at Screening
- •? Abnormal ECG, including QTcF > 470 ms (women) based on the Fridericia correction where QTcF = QT/RR0.33
- •? Left-handed
- •? Smoking = 20 cigarettes per day
- •? BMI (weight [kg]/height [m]²) outside range of 18 to 35 kg/m²
- •? Relevant history, or presence upon clinical examination of cardiac, ophthalmologic, pulmonary, endocrine (diabetes), blood disease, gastro-intestinal, hepatic or renal disease or other condition which in the opinion of the Investigator could interfere with the test procedures
- •?History of cancer, except for basal cell or Stage 1 squamous cell carcinoma of skin which is in remission for at least 5 years prior to study Visit 1
- •?Meeting the diagnostic criteria for a psychotic disorder or schizophrenia, as determined by the SCID-I at Visit 1
- •?Current or history of significant neurological condition (such as stroke, traumatic brain injury, space occupying lesions, multiple sclerosis, Parkinson’s disease, vascular dementia, transient ischemic attack)
- •?A history of positive HIV test
- •?Medical history of cranial surgery
- •?Significant visual impairment including colour blindness, or history of ocular treatment including corrective laser eye surgery, or ongoing condition, which might interfere with the performance of the behavioural tasks or fMRI tasks
- •?Treatment with psychotropic medication within 28 days prior to Visit 1 (except medication received will not interfere with the study procedures or compromise safety in opinion of investigator)
- •?Treatment with experimental drug and / or experimental medical device within 30 days of randomisation or within a period less than 5 times the drug’s half-life, whichever is longer
- •?Known hypersensitivity to Citalopram or any of their excipients.
- •?History of severe drug allergy or hypersensitivity
- •?Unable or unwilling to comply with study procedures, including study prohibitions and restrictions
- •?History of claustrophobia or inability to tolerate scanner environment
- •?Fulfilling any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants)
- •?Clinically relevant structural brain abnormality as determined by prior MRI scan
- •?Planned medical treatment within the study period that might interfere with the study procedures.
- •?Staff member
研究者
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