Neurobiological Effects of Oxytocin on Social Decision Making in Schizophrenia: A Pharmacological MRI Study
Overview
- Phase
- Not Applicable
- Intervention
- Oxytocin nasal spray
- Conditions
- Schizophrenia
- Sponsor
- National Institute of Mental Health and Neuro Sciences, India
- Enrollment
- 55
- Primary Endpoint
- fMRI changes with oxytocin while performing ultimatum game and at rest
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Dr Naren P Rao
Additional Professor of Psychiatry
National Institute of Mental Health and Neuro Sciences, India
Eligibility Criteria
Inclusion Criteria
- •Males between 18 and 45 years with at least 7 years of education
- •The DSM-IV diagnosis of Schizophrenia or schizoaffective or schizophreniform disorder
- •capacity to provide informed consent
Exclusion Criteria
- •Current comorbid DSM-IV axis I diagnosis
- •General impaired intellectual functioning
- •history of alcohol or substance abuse or dependence in the last 12 months
- •contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
- •past history of head injury resulting in loss of consciousness or neurosurgery
- •concomitant severe medical conditions
- •metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI.
- •Healthy volunteers:
- •Inclusion Criteria:
- •Males between 18 and 45 years with at-least 7 years education
Arms & Interventions
oxytocin
Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order
Intervention: Oxytocin nasal spray
Placebo
Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order
Intervention: Placebo
Outcomes
Primary Outcomes
fMRI changes with oxytocin while performing ultimatum game and at rest
Time Frame: 90 minutes
Changes in brain activity and functional connectivity