Circulating Oxytocin Changes in Response to the Oxytocin System Stimulator MDMA in Patients With ⦠(NCT04648137) | Clinical Trial Compass
CompletedNot Applicable
Circulating Oxytocin Changes in Response to the Oxytocin System Stimulator MDMA in Patients With Diabetes Insipidus and Healthy Controls
Switzerland30 participantsStarted 2021-02-05
Plain-language summary
This study is to evaluate oxytocin levels in response to MDMA administration as compared to placebo in patients with diabetes insipidus and healthy volunteers.
Who can participate
Age range18 Years ā 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria 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-
Exclusion Criteria:
* 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
What they're measuring
1
area under the concentration time curve in oxytocin level
Timeframe: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA