NCT04177719

Neurobiological Effects of Oxytocin in Schizophrenia

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: National Institute of Mental Health and Neuro Sciences, India · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Oxytocin	oxytocin will be given intranasally. The order of administration will be counterbalanced
DRUG	Placebo	Saline placebo will be given intranasally. The order of administration will be counterbalanced

Timeline

• Start date: 2019-11-08
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2019-11-26
• Last updated: 2021-08-31

Locations

1 site across 1 country: India