Schizophrenia
Conditions
Brief summary
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.
Interventions
DRUGOxytocin
oxytocin will be given intranasally. The order of administration will be counterbalanced
DRUGPlacebo
Saline placebo will be given intranasally. The order of administration will be counterbalanced
Sponsors
National Institute of Mental Health and Neuro Sciences, India
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Schizophrenia group Inclusion Criteria: 1. Diagnosis of schizophrenia or schizoaffective disorder 2. Males between 18 and 45 years 3. capacity to provide informed consent
Exclusion criteria
1. current comorbid axis I diagnosis and no alcohol/substance abuse/dependence in the last 12 months (except nicotine) 2. Contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma 3. Contraindication to MRI like implants/claustrophobia 4. Past history of head injury resulting in loss of consciousness or neurosurgery 5. Concomitant severe medical conditions 6. On treatment with benzodiazepine medications for at least 8 weeks 7. Contraindication to Positron emission tomography Healthy volunteers Inclusion Criteria: 1. Males between 18 and 45 years 2. capacity to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PET | 90 minues | changes in \[18F\] flumazenil specific binding |
| fMRI changes | 90 minutes | changes in brain functional connectivity |
| MRS | 90 minutes | Changes in brain chemistry measured using MRS |
Countries
India
Contacts
Primary ContactNaren P Rao, MD
Outcome results
None listed