Schizophrenia, schizotypal and delusional disorders Mental and Behavioural Disorders
Conditions
Interventions
This is a randomised, double-blind, 40 IU intranasal oxytocin versus placebo single-dose challenge with a crossover design (1-week washout). Oxytocin administration will follow international guideline
Sponsors
King's College London
South London and Maudsley NHS Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The are no secondary outcome measures | — |
Countries
England, United Kingdom
Outcome results
None listed