Informazioni generali
  • Categoria della malattia Malattie endocrinologiche (non cancro) (BASEC)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Basilea
    (BASEC)
  • Responsabile dello studio Mirjam Christ-Crain mirjam.christ-crain@usb.ch (BASEC)
  • Fonte dati BASEC: Importato da 29.07.2026 ICTRP: N/A
  • Ultimo aggiornamento 29.07.2026 09:15
HumRes67779 | SNCTP000006777 | BASEC2025-02452

MDMA as a Stimulation Test for Possible Oxytocin Deficiency in Adults with Autism Spectrum Disorder and Healthy Controls

  • Categoria della malattia Malattie endocrinologiche (non cancro) (BASEC)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Basilea
    (BASEC)
  • Responsabile dello studio Mirjam Christ-Crain mirjam.christ-crain@usb.ch (BASEC)
  • Fonte dati BASEC: Importato da 29.07.2026 ICTRP: N/A
  • Ultimo aggiornamento 29.07.2026 09:15

Descrizione riassuntiva dello studio

Oxytocin is a hormone produced in the brain and released into the bloodstream by the pituitary gland. It is involved in important psychosocial aspects and has a positive influence on mother-child relationships or partnership relationships, as well as on feelings such as love, trust, and relaxation. Among laypeople, the hormone is also referred to as the cuddle or love hormone. Changes in the oxytocin system have been studied for many years in connection with autism spectrum disorder, as some affected individuals exhibit peculiarities in social perception and interaction. There is scientific evidence that in some adult individuals with autism spectrum disorder, the release or effect of oxytocin may be altered. However, individual measurements of hormone levels in the blood are not sufficient to reliably assess the function of the oxytocin system. A new approach is to test how well the oxytocin system responds to a targeted stimulus. Such a response is called a "stimulation test." The substance MDMA (3,4-methylenedioxymethamphetamine) is known to trigger a strong, short-term increase in oxytocin levels. This effect has been confirmed multiple times in healthy individuals. With this study, we aim to find out how strongly the oxytocin system of adult individuals with autism spectrum disorder responds to MDMA compared to healthy controls. This will help us better understand whether a portion of adult individuals with autism spectrum disorder may have impaired oxytocin release.

(BASEC)

Intervento studiato

MDMA (3,4-methylenedioxymethamphetamine, 100mg) as a stimulation test.

(BASEC)

Malattie studiate

Autism Spectrum Disorder

(BASEC)

Criteri di partecipazione

Inclusion Criteria – Patients
• Adults (18–65 years) with a confirmed diagnosis of autism spectrum disorder according to DSM-5, validated by ADOS and/or ADI-R.

Inclusion Criteria – Healthy Controls
• Healthy participants,
• matched by age, gender, BMI, and ovarian hormone status (menopause/estrogen therapy/hormonal contraceptives),
• no medication except hormonal contraception,
• Autism Spectrum Quotient <32.

(BASEC)


Criteri di esclusione

• Illegal substances (except cannabis) >10 times in life or use in the last 2 months.
• Alcohol >15 standard drinks/week.
• Smoking >10 cigarettes/day.
• Cardiovascular diseases (CAD, heart failure LVEF <40%, stroke <3 months, atrial fibrillation/flutter, WPW syndrome).
• Uncontrolled hypertension (>140/90 mmHg) or hypotension (systole <85 mmHg).
• Current or former severe psychiatric illness (e.g., depression, schizophrenia).
• Psychotic illness in first-degree relatives.
• Pregnancy or breastfeeding.
• Chronic kidney insufficiency stage >III (GFR <30 ml/min).
• Liver cirrhosis or ALAT/ASAT >2.5× above normal.
• Confirmed epilepsy.

(BASEC)

Luogo dello studio

Basilea

(BASEC)

non disponibile

Sponsor

Mirjam Christ-Crain (University Hospital Basel)

(BASEC)

Contatto per ulteriori informazioni sullo studio

Persona di contatto in Svizzera

Mirjam Christ-Crain

+4161 265 25 25

mirjam.christ-crain@usb.ch

Universitätsspital Basel Dept. für Endokrinologie Petersgraben 4 4031 Basel

(BASEC)

Informazioni scientifiche

non disponibile

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione d'etica svizzera nord-ovest/centrale EKNZ

(BASEC)

Data di approvazione del comitato etico

02.02.2026

(BASEC)


ID di studio ICTRP
non disponibile

Titolo ufficiale (approvato dal comitato etico)
Circulating Oxytocin Changes in Response to MDMA vs. Placebo in Adult Patients with Autism Spectrum Disorder and Matched Healthy Controls – A Randomized Placebo-Controlled Cross-Over Trial – The OxySPECTRUM Study (BASEC)

Titolo accademico
non disponibile

Titolo pubblico
non disponibile

Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
non disponibile

Criteri di inclusione/esclusione
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non disponibile

Endpoint primari e secondari
non disponibile

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Data di registrazione
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Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
non disponibile

Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

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