Oxytocin and Social Decision Making in Schizophrenia

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Schizophrenia group -

Inclusion criteria

Males between 18 and 45 years with at least 7 years of education
The DSM-IV diagnosis of Schizophrenia or schizoaffective or schizophreniform disorder
capacity to provide informed consent

Exclusion criteria

Current comorbid DSM-IV axis I diagnosis
General impaired intellectual functioning
history of alcohol or substance abuse or dependence in the last 12 months
contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
past history of head injury resulting in loss of consciousness or neurosurgery
concomitant severe medical conditions
metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI.

Healthy volunteers:

Inclusion criteria

Males between 18 and 45 years with at-least 7 years education
Capacity to provide informed consent
absence of past or present psychiatric illnesses including substance abuse/dependence

Exclusion criteria

General impaired intellectual functioning
contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
past history of head injury resulting in loss of consciousness or neurosurgery
concomitant severe medical conditions
metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI.
Family history of schizophrenia or schizoaffective or schizophreniform disorder in a first-degree relative

Treatment and study plan

Oxytocin nasal spray

Drug

Single-dose oxytocin will be administered intranasally

Placebo

Drug

Primary outcomes

fMRI changes with oxytocin while performing ultimatum game and at rest

Time frame: 90 minutes

Changes in brain activity and functional connectivity

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health and Neuro Sciences, India

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Nov 25, 2019
Registry last updated: Sep 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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