Oxytocin and Social Decision Making in Schizophrenia

NCT ID: NCT04176835

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-09-30

Brief 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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

oxytocin

Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order

Group Type: EXPERIMENTAL

Oxytocin nasal spray

Intervention Type: DRUG

Single-dose oxytocin will be administered intranasally

Placebo

Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Oxytocin nasal spray

Single-dose oxytocin will be administered intranasally

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

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. 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:

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health and Neuro Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Dr Naren P Rao

Additional Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

00861

Identifier Type: -

Identifier Source: org_study_id