Clinical trial NCT04177719: Neurobiological Effects of Oxytocin in Schizophrenia
Official title: Understanding the Neurobiological Effects of Oxytocin on Social Trust Deficits in Schizophrenia: A Multimodal Imaging - Genetics Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Lead sponsor: National Institute of Mental Health and Neuro Sciences, India
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


Eligibility 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

Exclusion Criteria:

1. Lifetime diagnosis of psychiatric illness including substance dependence
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
8. Family history of schizophrenia, schizoaffective or schizophreniform disorder in family member

Primary outcomes:
measure: PET
timeFrame: 90 minues
measure: fMRI changes
timeFrame: 90 minutes
measure: MRS
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: National Institute of Mental Health and Neurosciecnes
state: Karnataka
Study officials:
References: