Low-dose MDMA as a stimulation test for a possible oxytocin deficiency in patients with vasopressin deficiency and healthy controls

Switzerland (ICTRP)

ICTRP Studien-ID
NCT06789705 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
Plasma oxytocin changes in response to low-dose MDMA vs. placebo in patients with arginine vasopressin deficiency (central diabetes insipidus) and healthy controls – the OxyMAX Study (BASEC)

Wissenschaftlicher Titel
Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency (Central Diabetes Insipidus) and Healthy Controls - the OxyMAX Study (ICTRP)

Öffentlicher Titel
Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency and Healthy Controls (ICTRP)

Untersuchte Krankheit(en)
Central Diabetes Insipidus (ICTRP)

Untersuchte Intervention
Drug: MDMAOther: Placebo (ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). (ICTRP)

Ein-/Ausschlusskriterien
Inclusion criteria patients:

1. Adult patients with confirmed diagnosis of Arginine Vasopressin deficiency (central
diabetes insipidus)2 or with only anterior pituitary deficiency

Inclusion criteria healthy controls:

1. Adult healthy controls

2. Matched for age, sex, Body mass index, and oestrogen replacement/menopause/hormonal
contraceptives to patients

3. No medication, except hormonal contraception

Exclusion Criteria:

1. Participation in a trial with investigational drugs within 30 days

2. Illicit substance use (except for cannabis) more than 10 times in lifetime or any
time within the previous two months

3. Consumption of alcoholic beverages >15 drinks/week

4. Tobacco smoking >10 cigarettes/day

5. Cardiovascular disease (coronary artery disease, heart failure Left ventricular
ejection fraction <40%, stroke in the last 3 months, atrial fibrillation/flatter,
Wolff-Parkinson-White-Syndrome)

6. Uncontrolled arterial hypertension (>140/90 mmHg) or hypotension (<85mmHg)

7. Current or previous major psychiatric disorder (e.g., major depression,
schizophrenia spectrum disorder)

8. Psychotic disorder in first-degree relatives

9. Regular intake of selective serotonin reuptake inhibitors or Monoamine oxidase
inhibitors

10. Pregnancy and breastfeeding

11. Diagnosed Chronic Kidney Disease > grade III (glomerular filtration rate < 30ml/min)

12. Diagnosed liver cirrhosis or alanine aminotransferase (ALAT) or aspartate
aminotransferase (ASAT) levels 2.5 times above the normal range (ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte
Area under the concentration-time curve in plasma oxytocin level (ICTRP)

Peak change in oxytocin plasma level;Time course of plasma oxytocin levels;Time course of plasma MDMA concentration;Subjective/emotional effects assessed on numeric analogue scales (NASs);Recognition of emotions and body expressions in the Emotion from Body expression and Emotion from Face (EmBody/EmFace) task;Recognition of emotions and body expressions in the face emotion recognition task (FERT);Anxiety level with the State-Trait Anxiety Inventory (STAI-S);Anxiety level with the State-Trait Anxiety Inventory (STAI-T);Number of complaints;Number of adverse effects;Time course of plasma copeptin;Time course of plasma Adrenocorticotropic hormone (ACTH);Time course of plasma cortisol;Time course of plasma prolactin;Time course of plasma neurophysin I;Alexithymia level using the Toronto-Alexithymia-Scale 20 (TAS-20);Depression level using the Beck-Depressions-Inventory II (BDI-II);General physical & mental health using the posterior-pituitary quality of life questionnaire (PP-QoL);General physical & mental health using the Patient-Reported Outcomes Measurement Information System (PROMIS);Autistic traits level using the Autism-Spectrum Quotient Test (AQ);Eating disturbances level using the Three-Factor Eating Questionnaire-Revised 18 Item (TFEQ-R18);Resting energy expenditure (REE) in kcal per 24 hours, time course of plasma glucose, insulin and c-peptide, subjective saturation effects assessed on a 10-point NAS.;Time course of plasma glucose;Time course of plasma insulin;Time course of plasma c-peptide;Subjective saturation effects;Assessments of clinical variable blood pressure;Assessments of clinical variable heart rate;Assessments of clinical variable body temperature;Assessments of laboratory variable plasma sodium;Assessments of laboratory variable potassium (ICTRP)

Registrierungsdatum
nicht verfügbar

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
nicht verfügbar

Weitere Kontakte
Mirjam Christ-Crain, Prof.;Mirjam Christ-Crain, Prof.;Mirjam Christ-Crain, Prof., Mirjam.Christ-Crain@usb.ch, +41 61 265 25 25;+41 61 265 25 25, University Hospital, Basel, Switzerland, (ICTRP)

Sekundäre IDs
2024-01105, kt24ChristCrain3 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06789705 (ICTRP)