Oxytocin and Social Decision Making in Schizophrenia

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Oxytocin nasal spray
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Schizophrenia group - 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 Capacity to provide informed consent absence of past or present psychiatric illnesses including substance abuse/dependence Exclusion criteria: General impaired intellectual functioning 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. Family history of schizophrenia or schizoaffective or schizophreniform disorder in a first-degree relative

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oxytocin<br>Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order | Drug: Oxytocin nasal spray<br>* Single-dose oxytocin will be administered intranasally<br>|
| Placebo Comparator: Placebo<br>Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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