Oxytocin and Social Decision Making in Schizophrenia | NCT04176835

Studies
Oxytocin and Social Decision Making in Schizophrenia

NCT04176835

Sponsor

National Institute of Mental Health and Neuro Sciences, India

Status

Completed

Last Update Posted

Sep 29, 2022Actual

Enrollment

55Actual

Phase

Not Applicable

Conditions

Schizophrenia

Interventions

Oxytocin nasal spray
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016Actual

Primary Completion Date

Sep 2019Actual

Completion Date

Sep 2019Actual

First Submitted Date

Nov 22, 2019

First Submission Date that Met QC Criteria

Nov 22, 2019

First Posted Date

Nov 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2022

Last Update Posted Date

Sep 29, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Oxytocin nasal spray	Drug	Single-dose oxytocin will be administered intranasally	oxytocin

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders