Oxytocin and Social Decision Making in Schizophrenia

NCT04176835 | Completed

• 1 other identifier: 00861
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• fMRI changes with oxytocin while performing ultimatum game and at rest

  Changes in brain activity and functional connectivity

  90 minutes

Study Arms (2)

oxytocin

EXPERIMENTAL

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

Drug: Oxytocin nasal spray

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Oxytocin nasal spray DRUG

Single-dose oxytocin will be administered intranasally

oxytocin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor of Psychiatry

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 25, 2019
• Study Start: April 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share