EUCTR2014-005239-15-DE进行中（未招募）1 期
Effects of mineralocorticoid receptor stimulation on cognitive bias and social cognition in patients with major depression and healthy controls: what’s the role of NMDA receptors?
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
- 232
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 adults aged 18 to 65,
- •ability to provide written informed consent
- •Only for patients: Diagnosis major depression according to DSM-5 & 18 points or more in the 17-item Hamilton Depression Rating Scale (Hamilton, 1960),
- •effective contraception in women (defined as Pearl index <1), or reliable abstinence
- •from any heterosexual relationships in women of childbearing potential, or postmenopausal status (amenorrhea for at least 12 months without alternative reason).
- •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 232
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •taking psychotropic drugs (eg, antidepressants) within the last 5 days,
- •substance abuse or dependence (except nicotine) within the last 6 months,
- •presence of other psychiatric disorders (current or past psychosis, schizoaffective or bipolar disorder)
- •presence of a neurodegenerative disease,
- •existence of a current or past organic brain damage (pervasive developmental disorder, mental retardation, epilepsy, head injury with loss of consciousness)
- •presence of acute suicidality,
- •Treatment with fluoxetine or an injectable antipsychotic within the last 30 days.
- •presence of an endocrine disorder or taking a medication with neuroendocrine effects (eg insulin dependent diabetes mellitus, taking steroids)
- •existence of current pregnancy or lactation,
- •non-agreement to save and transmit pseudonymised study data within the clinical Trial
- •presence of cardiovascular problems (cardiac insufficiency)
- •hypokalemia (potassium deficiency)
- •people who are accommodated in an psychiatric institution based on an official or judicial decision
- •people who are dependent on the investigator, sponsor or study centre
- •known drug intolerance
- •People whose laboratory test results do not meet the following eligibility limits: AST and ALT < 2 x upper limit of normal, Kreatinin < 1,5 x lower limit of normal
- •People whose systolic blood pressure is outside 90 and 140 mmHg, People whose diastolic blood pressure is outside 50 and 90 mmHg, and People whose heart rate is outside 50 and 90 beats per minute
- •dysfunctions of the heart (except : AV block 1st degree)
- •Participation in any drug - interventional clinical trial within the last month or during the study period
研究者
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