Neurobiological Effects of Oxytocin in Schizophrenia

Not Applicable

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: Oxytocin

• Registration Number: NCT04177719
• Lead Sponsor: National Institute of Mental Health and Neuro Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-08
• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-26
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-08-31
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced
Oxytocin	Oxytocin	Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Institute of Mental Health and Neurosciecnes; 🇮🇳 Bangalore, Karnataka, India