Neurobiological Effects of Oxytocin in Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04177719
• Other study ID #: 00908
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2019
• Est. completion date: April 2022

Study information

• Verified date: August 2021
• Source: National Institute of Mental Health and Neuro Sciences, India
• Contact: Naren P Rao, MD
• Phone: 08026995879
• Email: narenrao[@]nimhans.ac.in
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Oxytocin
oxytocin will be given intranasally. The order of administration will be counterbalanced
• Placebo
Saline placebo will be given intranasally. The order of administration will be counterbalanced

Locations

Country	Name	City	State
India	National Institute of Mental Health and Neurosciecnes	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health and Neuro Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET	changes in [18F] flumazenil specific binding	90 minues
Primary	fMRI changes	changes in brain functional connectivity	90 minutes
Primary	MRS	Changes in brain chemistry measured using MRS	90 minutes