Oxytocin and Social Decision Making in Schizophrenia

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Placebo; Drug: Oxytocin nasal spray

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oxytocin; Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order	Drug: Oxytocin nasal spray; Single-dose oxytocin will be administered intranasally
Placebo Comparator: Placebo; Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fMRI changes with oxytocin while performing ultimatum game and at rest	Changes in brain activity and functional connectivity	90 minutes

Collaborators and Investigators

• Sponsor: National Institute of Mental Health and Neuro Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 00861

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No