Oxytocin and Social Decision Making in Schizophrenia

National Institute of Mental Health and Neuro Sciences, India

Status: Completed

Conditions: Schizophrenia

Treatments: Drug: Oxytocin nasal spray; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04176835

00861

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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55 participants in 2 patient groups, including a placebo group

oxytocin

Experimental group

Description:

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

Treatment:

Drug: Oxytocin nasal spray

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo