Oxytocin and Social Decision Making in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Neurobiological Effects of Oxytocin on Social Decision Making in Schizophrenia: A Pharmacological MRI Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04176835
• Other study ID #: 00861
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: September 2019

Study information

• Verified date: September 2022
• Source: National Institute of Mental Health and Neuro Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Oxytocin nasal spray
Single-dose oxytocin will be administered intranasally
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

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