Circulating Oxytocin Changes in Response to the Oxytocin System Stimulator MDMA in Patients With Diabetes Insipidus and Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- area under the concentration time curve in oxytocin level
研究概览
简要总结
This study is to evaluate oxytocin levels in response to MDMA administration as compared to placebo in patients with diabetes insipidus and healthy volunteers.
详细描述
Disruption of the hypothalamic-pituitary axis due to congenital abnormalities, tumors or head trauma may cause anterior and/or posterior pituitary deficiency also known as partial or panhypopituitarism. Patients with hypopituitarism, especially those with panhypopituitarism (i.e., anterior and posterior insufficiency) often report residual symptoms and lower quality of life despite adequate substitution treatment of deficient pituitary hormones. A recent study identified a potential oxytocin deficient state in men with combined anterior and posterior deficiency. Due to the close proximity of vasopressin and oxytocin, disruption of the vasopressin system leading to diabetes insipidus could as well disturb the oxytocin system leading to low oxytocin levels. It is therefore possible that the increased psychopathology and reduced quality of life as observed in patients with central diabetes insipidus is caused by an oxytocin deficiency. Several studies documented marked acute increases in circulating oxytocin levels in response to 3,4-methylenedioxymethamphetamine (MDMA) administration as compared to placebo in healthy volunteers.
MDMA could therefore be useful as a provocation test to detect an oxytocin deficiency in patients with central diabetes insipidus. This study is to investigate if oxytocin provocation following a single dose administration of MDMA is reduced in patients with central diabetes insipidus as compared to healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diabetes insipidus:
- •Confirmed diagnosis of central diabetes insipidus
- •Inclusion criteria healthy volunteers:
- •Matched for age, sex, BMI and estrogen replacement/menopause/hormonal contraceptives to patients with central diabetes insipidus
- •No medication, except hormonal contraception-
排除标准
- •Familial central diabetes insipidus
- •Participation in a trial with investigational drugs within 30 days
- •Illicit substance use (with the exception of cannabis) more than 10 times in lifetime or any time within the previous two months
- •Consumption of alcoholic beverages >15 drinks/week
- •Tobacco smoking >10 cigarettes/day
- •Cardiovascular disease (coronary artery disease, heart failure, left ventricular ejection fraction ( LVEF) <40%, stroke in the last 3 months, atrial fibrillation/flatter, Wolff-Parkinson-White syndrome (WPW)-Syndrome)
- •Uncontrolled arterial hypertension (>140/90 mmHg) or hypotension (syst blood pressure <85mmHg)
- •Current or previous major psychiatric disorder (e.g., major depression, schizophrenia spectrum disorder)
- •Psychotic disorder in first-degree relatives
- •Regular intake of selective serotonin reuptake inhibitor (SSRI), monoamine oxidase (MAO)-Inhibitors
- •Pregnancy and breastfeeding
- •Diagnosed chronic kidney disease (CKD) > grade III (GRF < 30ml/min)
- •Diagnosed liver cirrhosis or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range
研究组 & 干预措施
Healthy volunteers
干预措施: study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy) (Diagnostic Test)
Healthy volunteers
干预措施: Control intervention: Placebo (Diagnostic Test)
Patients with central diabetes insipidus
干预措施: study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy) (Diagnostic Test)
Patients with central diabetes insipidus
干预措施: Control intervention: Placebo (Diagnostic Test)
结局指标
主要结局
area under the concentration time curve in oxytocin level
时间窗: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA
area under the concentration time curve in oxytocin level from baseline oxytocin measurement (before intake) to 6 hours after a single administration of MDMA (100mg) as compared to placebo in the same subjects between patients with central diabetes insipidus and healthy volunteers.
次要结局
- Time course of plasma OT levels(from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA)
- Level of depression using the Beck-Depressions-Inventory II (BDI-II)(from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA)
- Time course of prolactin levels(from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA)
- Empathy in the multifaceted empathy task (MET)(from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA)
- Anxiety level with the State-Trait Anxiety Inventory (STAI)(from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA)
- Level of general physical & mental health using the short form health survey (SF-36)(from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA)
- Subjective/emotional effects(from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA)
- Peak change in oxytocin (OT) plasma level(from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA)
- Time course of copeptin levels(from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA)
- Recognition of negative emotions in the face emotion recognition task (FERT)(from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA)
- Time course of plasma MDMA concentration(from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA)
- Time course of cortisol levels(from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA)
- Time course of adrenocorticotropic hormone (ACTH) levels(from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA)
- Level of Alexithymia using the Toronto-Alexithymia-Scale 20 (TAS-20)(from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA)