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This study is to evaluate oxytocin levels in response to MDMA administration as compared to placebo in patients with diabetes insipidus and healthy volunteers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with central diabetes insipidus | Experimental |
| |
| Healthy volunteers | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy) | Diagnostic Test | single administration of MDMA (100mg): 3,4-methylenedioxymethamphetamine (MDMA, ecstasy) will be prepared as gelatin capsules with mannitol as the filler. MDMA will be administered in a single absolute dose of 100 mg corresponding to a medium high dose of (mean ± SD) 1.3 ± 0.3 mg/kg body weight. |
| Measure | Description | Time Frame |
|---|---|---|
| area under the concentration time curve in oxytocin level | 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. | from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA |
| Measure | Description | Time Frame |
|---|---|---|
| Peak change in oxytocin (OT) plasma level | Peak change in OT plasma level | from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA |
| Time course of plasma OT levels |
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Inclusion Criteria diabetes insipidus:
Inclusion criteria healthy volunteers:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mirjam Christ-Crain, Prof. Dr. med. | Endocrinology, Diabetes and Metabolism, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel, Endocrinology, Diabetes and Metabolism | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37192642 | Derived | Atila C, Holze F, Murugesu R, Rommers N, Hutter N, Varghese N, Sailer CO, Eckert A, Heinrichs M, Liechti ME, Christ-Crain M. Oxytocin in response to MDMA provocation test in patients with arginine vasopressin deficiency (central diabetes insipidus): a single-centre, case-control study with nested, randomised, double-blind, placebo-controlled crossover trial. Lancet Diabetes Endocrinol. 2023 Jul;11(7):454-464. doi: 10.1016/S2213-8587(23)00120-1. Epub 2023 May 13. |
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Randomized, double-blind, placebo-controlled, cross-over (MDMA versus placebo, within subject comparison) study in patients with central diabetes insipidus versus healthy controls (between-subject comparison). Participants will be randomized to receive either first placebo or first MDMA, respectively.
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| Control intervention: Placebo | Diagnostic Test | Identical placebo (only mannitol) capsules |
|
Time course of plasma OT levels
| from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA |
| Time course of plasma MDMA concentration | Time course of plasma MDMA concentration | from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA |
| Time course of cortisol levels | Time course of cortisol levels | from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA |
| Time course of prolactin levels | Time course of prolactin levels | from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA |
| Time course of copeptin levels | Time course of copeptin levels | from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA |
| Time course of adrenocorticotropic hormone (ACTH) levels | Time course of ACTH levels | from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA |
| Subjective/emotional effects | Subjective/emotional effects assessed on a 10-point visual analog scale (e.g., feelings of anxiety, pleasure, fear, 0 = better outcome,10 = worst outcome) | from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA |
| Recognition of negative emotions in the face emotion recognition task (FERT) | Recognition of negative emotions in the face emotion recognition task (FERT) | from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA |
| Empathy in the multifaceted empathy task (MET) | 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) | Anxiety level with the State-Trait Anxiety Inventory (STAI) | from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA |
| Level of Alexithymia using the Toronto-Alexithymia-Scale 20 (TAS-20) | Level of Alexithymia using the Toronto-Alexithymia-Scale 20 (TAS-20); total scores can range from 20-100, with higher scores indicating greater impairment/challenges | from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA |
| Level of depression using the Beck-Depressions-Inventory II (BDI-II) | Level of depression using the Beck-Depressions-Inventory II (BDI-II); 21-question multiple-choice self-report inventory. Higher total scores indicate more severe depressive symptoms. | 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) | Level of general physical & mental health using the short form health survey (SF-36); 36-item, patient-reported survey of patient health; the higher the score, the more favourable the health state. | from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA |
| ID | Term |
|---|---|
| D003919 | Diabetes Insipidus |
| D020790 | Diabetes Insipidus, Neurogenic |
| D007018 | Hypopituitarism |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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