Oxytocin and Social Decision Making in Schizophrenia

Neurobiological Effects of Oxytocin on Social Decision Making in Schizophrenia: A Pharmacological MRI Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04176835

Enrollment

Registered

2019-11-25

Start date

2016-04-30

Completion date

2019-09-30

Last updated

2022-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Brief summary

schizophrenia patients and healthy volunteers will be included. Subjects who meet the inclusion and exclusion criteria for the study will be recruited. After completion of clinical assessments and neuropsychological assessments, all subjects will undergo two fMRI scans. In one scan subjects will receive a single dose of intranasal oxytocin and in another scan, they will receive intranasal saline. The order of administration of oxytocin or saline will be counterbalanced so that they are not administered in the same order to all subjects. Subjects will be blind to the drug administered.

Interventions

DRUGOxytocin nasal spray

Single-dose oxytocin will be administered intranasally

DRUGPlacebo

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

Schizophrenia group - Inclusion Criteria: 1. Males between 18 and 45 years with at least 7 years of education 2. The DSM-IV diagnosis of Schizophrenia or schizoaffective or schizophreniform disorder 3. capacity to provide informed consent

Exclusion criteria

1. Current comorbid DSM-IV axis I diagnosis 2. General impaired intellectual functioning 3. history of alcohol or substance abuse or dependence in the last 12 months 4. contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma 5. past history of head injury resulting in loss of consciousness or neurosurgery 6. concomitant severe medical conditions 7. metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI. Healthy volunteers: Inclusion Criteria: 1. Males between 18 and 45 years with at-least 7 years education 2. Capacity to provide informed consent 3. absence of past or present psychiatric illnesses including substance abuse/dependence

Design outcomes

Primary

Measure	Time frame	Description
fMRI changes with oxytocin while performing ultimatum game and at rest	90 minutes	Changes in brain activity and functional connectivity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026