Circulating Oxytocin Changes in Response to the Oxytocin System Stimulator MDMA in Patients With Diabetes Insipidus and Healthy Controls
Condition: Diabetes Insipidus
MeSH terms: Diabetes Insipidus; Diabetes Mellitus
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy); Control intervention: Placebo
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): 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.; Identical placebo (only mannitol) capsules
Intervention MeSH terms: N-Methyl-3,4-methylenedioxyamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 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.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: central diabetes insipidus; oxytocin levels; 3,4-methylenedioxymethamphetamine (MDMA); hypothalamic-pituitary axis; hypopituitarism; vasopressin