How does oxytocin affect brain functioning in people at high risk of developing psychosis?

Not Applicable

Completed

• Conditions: Schizophrenia, schizotypal and delusional disorders; Mental and Behavioural Disorders

• Registration Number: ISRCTN48799530
• Lead Sponsor: King's College London

Brief Summary

2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32655132/ Intranasal oxytocin increases heart-rate variability in men at clinical high risk for psychosis: a proof-of-concept study (added 15/03/2023) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30626906/ Oxytocin modulates hippocampal perfusion (added 15/03/2023) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32572020/ Oxytocin on brain activation during inferring others’ beliefs and social emotions (added 15/03/2023) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30928180/ Oxytocin on glutamate and other metabolites (added 15/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-10-17
• Study Start: 2023-03-17
• Last Update Posted: 17 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Among the new referrals to the OASIS service, South London and Maudsley NHS Foundation Trust, we will enroll those meeting inclusion criteria for a UHR state for psychosis (as defined on the CAARMS revised version questionnaire).

Exclusion Criteria

1. Personal history of psychotic illness (i.e. schizophrenia, schizoaffective disorder or related psychosis)
2. Aged below 18 years old
3. Aged over 35 years old
4. Significant cognitive deficit (IQ<60 as measured by the shortened WAIS)
5. Significant history of drug or alcohol misuse or dependence
6. Severe neurological and medical conditions
7. Evidence of hyponatremia in participant's recent blood test
8. Rejection of informed consent
9. Pregnancy (apply to women of childbearing age)
10. Breastfeeding (applies to women of childbearing age)
11. Non-use of contraceptive methods (apply to women of childbearing age).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Regional brain response to oxytocin versus placebo challenge in subjects at ultra-high risk (UHR) for psychosis measured using MRI, which includes fMRI tasks of social cognition and other neuroimaging readouts (arterial spin labelling, resting-state fMRI, and MR-spectroscopy), during the challenge

Secondary Outcome Measures

Name	Time	Method
The are no secondary outcome measures