Exploring the mechanistic link between the oxytocinergic system and mindfulness training

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Psychological Phenomena [F02]

Trial duration

15 May 2025 → ongoing

Decision date (initial)

2025-03-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

KU Leuven

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To evaluate whether combinatory treatment approaches, pairing oxytocin administration to mindfulness-based training sessions can boost stress-regulatory effects in adults with heightened stress complaints, i.e., compared to administering each intervention as stand-alone. More specifically, change from baseline after oxytocin administration on behavioral measurements of psychological distress

Secondary objectives 2

1. Change from baseline after oxytocin administration on: • Other behavioral outcomes (e.g. depression and anxiety, sleep quality, social function, compassion, attachment, quality of life, negative thinking, mindfulness qualities)
2. The clinical trial also includes exploratory outcome measures examining treatment-mechanistic aspects of the oxytocin treatment: 1. Oxytocin and cortisol hormonal levels 2. Neurophysiological measurements of stress

Conditions and MedDRA coding

Psychological distress complaints

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. Must be between 18 and 50 years old at the time of signing the Informed Consent Form (ICF);
3. Self-report to currently experience mild to severe stress symptoms (as assessed using the stress subscale of DASS-21: 15-25: mild to moderate ; 26-34+: severe to extremely severe range)
4. Participants must have sufficient proficiency in Dutch to complete study tasks but do not need to be native speakers.

Exclusion criteria 12

1. Active use of psychotropic medication within 6 months prior to participation (including anti-depressants, anxiolytica, antipsychotica)
2. Significant hearing or vision impairments (that cannot be corrected) that would interfere with the assessments.
3. Known hypersensitivity to active substance or ingredients in the nasal sprays, including e.g. (history of) latex allergy.
4. Use of the following medicinal products during the nasal spray administration period: prostaglandins and their analogues, inhalation anesthetics, vasoconstrictors/sympathomimetic drugs, and caudal anesthesia
5. For women, being pregnant or breastfeeding, or planning to become pregnant.
6. Active engagement in psychological treatment within 6 months prior to participation (with psychologist or psychiatrist).
7. Has substantial experience with meditative practices (including but not limited to mindfulness, yoga, tai chi, or other similar practices) and meets any of the following criteria: a. Participant has participated in a multi-day meditation retreat or program during the past six months; b. Participant engages in meditative practices on a weekly basis or more frequently, for at least six consecutive weeks, within six month prior to the study.
8. Has used oxytocin chronically within the past five years, either independently or as part of a study.
9. Has a significant active medical condition including hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease which influence the metabolism of oxytocin (IMP).
10. Participants with a history of active epilepsy, defined as individuals experiencing seizures or requiring anticonvulsant therapy within the past 12 months, will be excluded from the study.
11. Has a known syndrome that interacts with the reproductive hormonal system (e.g. Prader-Willi or Angelman syndrome).
12. Participation in another clinical trial with IMP.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. self-perceived emotional stress socres using the self-report Perceived stress scale (PSS)

Secondary endpoints 1

1. Assessments of the following additional self-report questionnaires: Depression Anxiety Stress Scale (DASS-21), State adult Attachment Measure (SAAM), Self-Compassion Scale-Short Form (SCS-SF), Pittsburg Sleepquality index (PSQI), Quality of life (WHO-5), Perseverative Thinking Questionnaire (PTQ), Three Facet Mindfulness Questionnaire -SF (TFMQ-SF), Profile of Mood State (POMS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Kaat Alaerts

Public contact point

Organisation

UZ Leuven

Contact name

Kaat Alaerts

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications