Neurobiological Effects of Oxytocin in Schizophrenia

Study Overview
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Brief Summary
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22 male patients with schizophrenia and 22 male healthy volunteers will be included in the study. 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 multi-modal imaging sessions. In one scan they will receive intranasal oxytocin and in another scan will receive intranasal saline as control. The order of administration of the medication will be counterbalanced and subjects will be blind to the medication administered. Using the simultaneous PET-MRI scanner, PET and fMRI data will be collected simultaneously. Blood will be collected for analysis of oxytocin receptor gene polymorphism and its potential effect on brain activity.

Official Title
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Understanding the Neurobiological Effects of Oxytocin on Social Trust Deficits in Schizophrenia: A Multimodal Imaging - Genetics Study

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Schizophrenia group Inclusion Criteria: Diagnosis of schizophrenia or schizoaffective disorder Males between 18 and 45 years capacity to provide informed consent Exclusion Criteria: current comorbid axis I diagnosis and no alcohol/substance abuse/dependence in the last 12 months (except nicotine) Contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma Contraindication to MRI like implants/claustrophobia Past history of head injury resulting in loss of consciousness or neurosurgery Concomitant severe medical conditions On treatment with benzodiazepine medications for at least 8 weeks Contraindication to Positron emission tomography Healthy volunteers Inclusion Criteria: Males between 18 and 45 years capacity to provide informed consent Exclusion Criteria: Lifetime diagnosis of psychiatric illness including substance dependence contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma contraindication to MRI like implants/claustrophobia past history of head injury resulting in loss of consciousness or neurosurgery concomitant severe medical conditions on treatment with benzodiazepine medications for at least 8 weeks contraindication to Positron emission tomography Family history of schizophrenia, schizoaffective or schizophreniform disorder in family member

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: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin<br>Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced | Drug: Oxytocin<br>* oxytocin will be given intranasally. The order of administration will be counterbalanced<br>|
| Placebo Comparator: Placebo<br>Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced | Drug: Placebo<br>* Saline placebo will be given intranasally. The order of administration will be counterbalanced<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET | changes in [18F] flumazenil specific binding | 90 minues | 
| fMRI changes | changes in brain functional connectivity | 90 minutes | 
| MRS | Changes in brain chemistry measured using MRS | 90 minutes |