Neurobiological Effects of Oxytocin in Schizophrenia - Imaging Study

Study Overview
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Brief Summary
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To investigate whether 24IU oxytocin can result in changes in functional brain connectivity in patients with schizophrenia and healthy individuals using functional magnetic resonance imaging (fMRI). The study will also examine the effect of oxytocin receptor gene polymorphism on the functional connectivity

Official Title
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Neurobiological Effects of Oxytocin on Metacognitive Deficits in Schizophrenia: A Pharmacological - Imaging Genetics Study

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion and Exclusion Criteria: Schizophrenia subjects: Inclusion criteria 1) Males between 18 and 50 years 2) Diagnosis of DSM-IV schizophrenia, schizoaffective or schizophreniform disorder 3) capacity to provide informed consent, as evaluated by the MacArthur Competence Assessment Tool for Clinical Research Exclusion criteria General impairment in intellectual functioning History of alcohol or substance dependence in the last 12 months (with the exception of nicotine) 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 50 years Capacity to provide informed consent Exclusion criteria 1) Life-time diagnosis of psychiatric illnesses including substance abuse 2) General impairment in intellectual functioning 3) Past history of head injury resulting in loss of consciousness or neurosurgery 4) Concomitant severe medical or neurological conditions 5) Metal implants or paramagnetic objects or claustrophobia 6) Family history of schizophrenia, schizoaffective or schizophreniform disorder in family member (sibling, parent or offspring) 7) Contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Intervention Model: Single Group Assignment
Interventional Model Description: After completion of clinical and cognitive assessments, all subjects will undergo a baseline fMRI scan. Later subjects will receive24IU oxytocin and saline placebo in counterbalanced order on two separate days and undergo repeat fMRI scans.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: oxytocin<br>All subjects will receive both oxytocin and placebo in a counterbalanced design | Drug: oxytocin<br>* 24 International units of oxytocin or palcebo 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 |
| --- | --- | --- |
| fMRI changes with oxytocin | changes in functional brain connectivity | Upto 90 minutes after administration |