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Circulating Oxytocin Changes in Response to the Oxytocin System Stimulator MDMA in Patients With Diabetes Insipidus and Healthy Controls (OxyMA)

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ClinicalTrials.gov Identifier: NCT04648137
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE November 23, 2020
First Posted Date  ICMJE December 1, 2020
Last Update Posted Date February 9, 2021
Actual Study Start Date  ICMJE February 5, 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
area under the concentration time curve in oxytocin level [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2020)
  • Peak change in oxytocin (OT) plasma level [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Peak change in OT plasma level
  • Time course of plasma OT levels [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Time course of plasma OT levels
  • Time course of plasma MDMA concentration [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Time course of plasma MDMA concentration
  • Time course of cortisol levels [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Time course of cortisol levels
  • Time course of prolactin levels [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Time course of prolactin levels
  • Time course of copeptin levels [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Time course of copeptin levels
  • Time course of adrenocorticotropic hormone (ACTH) levels [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Time course of ACTH levels
  • Subjective/emotional effects [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Subjective/emotional effects assessed on a 10-point visual analog scale (e.g., feelings of anxiety, pleasure, fear, 0 = better outcome,10 = worst outcome)
  • Recognition of negative emotions in the face emotion recognition task (FERT) [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Recognition of negative emotions in the face emotion recognition task (FERT)
  • Empathy in the multifaceted empathy task (MET) [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Empathy in the multifaceted empathy task (MET)
  • Anxiety level with the State-Trait Anxiety Inventory (STAI) [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Anxiety level with the State-Trait Anxiety Inventory (STAI)
  • Level of Alexithymia using the Toronto-Alexithymia-Scale 20 (TAS-20) [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    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
  • Level of depression using the Beck-Depressions-Inventory II (BDI-II) [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    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.
  • Level of general physical & mental health using the short form health survey (SF-36) [ Time Frame: 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); 36-item, patient-reported survey of patient health; the higher the score, the more favourable the health state.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
  • Peak change in oxytocin (OT) plasma level [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Peak change in OT plasma level
  • Time course of plasma OT levels [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Time course of plasma OT levels
  • Time course of plasma MDMA concentration [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Time course of plasma MDMA concentration
  • Time course of cortisol levels [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Time course of cortisol levels
  • Time course of prolactin levels [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Time course of prolactin levels
  • Time course of copeptin levels [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Time course of copeptin levels
  • Time course of adrenocorticotropic hormone (ACTH) levels [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Time course of ACTH levels
  • Subjective/emotional effects [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Subjective/emotional effects assessed on a 10-point visual analog scale (e.g., feelings of anxiety, pleasure, fear, 0-10)
  • Recognition of negative emotions in the face emotion recognition task (FERT) [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Recognition of negative emotions in the face emotion recognition task (FERT)
  • Empathy in the multifaceted empathy task (MET) [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Empathy in the multifaceted empathy task (MET)
  • Anxiety level with the State-Trait Anxiety Inventory (STAI) [ Time Frame: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA ]
    Anxiety level with the State-Trait Anxiety Inventory (STAI)
  • Level of Alexithymia using the Toronto-Alexithymia-Scale 20 (TAS-20) [ Time Frame: 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 depression using the Beck-Depressions-Inventory II (BDI-II) [ Time Frame: 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 general physical & mental health using the short form health survey (SF-36) [ Time Frame: 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Circulating Oxytocin Changes in Response to the Oxytocin System Stimulator MDMA in Patients With Diabetes Insipidus and Healthy Controls
Official Title  ICMJE Circulating Oxytocin Changes in Response to the Oxytocin System Stimulator MDMA in Patients With Diabetes Insipidus and Healthy Controls
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Diabetes Insipidus
Intervention  ICMJE
  • Diagnostic Test: study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy)
    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.
  • Diagnostic Test: Control intervention: Placebo
    Identical placebo (only mannitol) capsules
Study Arms  ICMJE
  • Experimental: Patients with central diabetes insipidus
    Interventions:
    • Diagnostic Test: study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy)
    • Diagnostic Test: Control intervention: Placebo
  • Experimental: Healthy volunteers
    Interventions:
    • Diagnostic Test: study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy)
    • Diagnostic Test: Control intervention: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 23, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mirjam Christ-Crain, Prof. Dr. med. +41 61 265 25 25 Mirjam.Christ-Crain@usb.ch
Contact: Cihan Atila, Dr. cihan.atila@usb.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04648137
Other Study ID Numbers  ICMJE 2020-02147; me20ChristCrain4
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mirjam Christ-Crain, Prof. Dr. med. Endocrinology, Diabetes and Metabolism, University Hospital Basel
PRS Account University Hospital, Basel, Switzerland
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP