Oxytocin for Psychological distress

Inclusion criteria

• {"criterion_text":"- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures"}
• {"criterion_text":"- Must be between 18 and 50 years old at the time of signing the Informed Consent Form (ICF);"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Participants must have sufficient proficiency in Dutch to complete study tasks but do not need to be native speakers."}

Exclusion criteria

• {"criterion_text":"- Active use of psychotropic medication within 6 months prior to participation (including anti-depressants, anxiolytica, antipsychotica)"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Has a known syndrome that interacts with the reproductive hormonal system (e.g. Prader-Willi or Angelman syndrome)."}
• {"criterion_text":"- Participation in another clinical trial with IMP."}
• {"criterion_text":"- Significant hearing or vision impairments (that cannot be corrected) that would interfere with the assessments."}
• {"criterion_text":"- Known hypersensitivity to active substance or ingredients in the nasal sprays, including e.g. (history of) latex allergy."}
• {"criterion_text":"- Use of the following medicinal products during the nasal spray administration period: prostaglandins and their analogues, inhalation anesthetics, vasoconstrictors/sympathomimetic drugs, and caudal anesthesia"}
• {"criterion_text":"- For women, being pregnant or breastfeeding, or planning to become pregnant."}
• {"criterion_text":"- Active engagement in psychological treatment within 6 months prior to participation (with psychologist or psychiatrist)."}
• {"criterion_text":"- 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.\tParticipant has participated in a multi-day meditation retreat or program during the past six months; b.\tParticipant engages in meditative practices on a weekly basis or more frequently, for at least six consecutive weeks, within six month prior to the study."}
• {"criterion_text":"- Has used oxytocin chronically within the past five years, either independently or as part of a study."}
• {"criterion_text":"- 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)."}

Primary endpoints

• {"endpoint_text":"- self-perceived emotional stress socres using the self-report Perceived stress scale (PSS)","definition_or_measurement_approach":"Change from baseline after oxytocin administration measured using the self-report Perceived Stress Scale (PSS)."}

Secondary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Change from baseline after oxytocin administration measured by the listed self-report questionnaires (DASS-21, SAAM, SCS-SF, PSQI, WHO-5, PTQ, TFMQ-SF, POMS)."}

Other endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Exploratory/mechanistic measures: quantification of oxytocin and cortisol hormonal levels; neurophysiological measurements of stress (methods not further specified in the available metadata)."}

Belgium

Earliest CTIS Part Ii Submission Date

04-03-2025

Latest Decision Or Authorization Date

05-02-2026

Processing Time Days

338

Number Of Sites

1

Number Of Participants

140

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium