Schizophrenia Clinical Trial
Official title:
Neurobiological Effects of Oxytocin on Social Decision Making in Schizophrenia: A Pharmacological MRI Study
NCT number | NCT04176835 |
Other study ID # | 00861 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | September 2019 |
Verified date | September 2022 |
Source | National Institute of Mental Health and Neuro Sciences, India |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | September 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility | Schizophrenia group - Inclusion Criteria: 1. Males between 18 and 45 years with at least 7 years of education 2. The DSM-IV diagnosis of Schizophrenia or schizoaffective or schizophreniform disorder 3. capacity to provide informed consent Exclusion Criteria: 1. Current comorbid DSM-IV axis I diagnosis 2. General impaired intellectual functioning 3. history of alcohol or substance abuse or dependence in the last 12 months 4. contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma 5. past history of head injury resulting in loss of consciousness or neurosurgery 6. concomitant severe medical conditions 7. metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI. Healthy volunteers: Inclusion Criteria: 1. Males between 18 and 45 years with at-least 7 years education 2. Capacity to provide informed consent 3. absence of past or present psychiatric illnesses including substance abuse/dependence Exclusion criteria: 1. General impaired intellectual functioning 2. contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma 3. past history of head injury resulting in loss of consciousness or neurosurgery 4. concomitant severe medical conditions 5. metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI. 6. Family history of schizophrenia or schizoaffective or schizophreniform disorder in a first-degree relative |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Institute of Mental Health and Neuro Sciences, India |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fMRI changes with oxytocin while performing ultimatum game and at rest | Changes in brain activity and functional connectivity | 90 minutes |
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