Neurobiological Effects of Oxytocin in Schizophrenia | NCT04177719

Studies
Neurobiological Effects of Oxytocin in Schizophrenia

NCT04177719

Sponsor

National Institute of Mental Health and Neuro Sciences, India

Status

Unknown status

Last Update Posted

Aug 31, 2021Actual

Enrollment

44Estimated

Phase

Not Applicable

Conditions

Schizophrenia

Interventions

Oxytocin
Placebo

Countries

India

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

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 8, 2019Actual

Primary Completion Date

Apr 2022Estimated

Completion Date

Apr 2022Estimated

First Submitted Date

Nov 22, 2019

First Submission Date that Met QC Criteria

Nov 22, 2019

First Posted Date

Nov 26, 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

Aug 30, 2021

Last Update Posted Date

Aug 31, 2021Actual

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

22 male patients with schizophrenia and 22 male healthy volunteers will be included in the study. 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 multi-modal imaging sessions. In one scan they will receive intranasal oxytocin and in another scan will receive intranasal saline as control. The order of administration of the medication will be counterbalanced and subjects will be blind to the medication administered. Using the simultaneous PET-MRI scanner, PET and fMRI data will be collected simultaneously. Blood will be collected for analysis of oxytocin receptor gene polymorphism and its potential effect on brain activity.

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

44Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxytocin	Experimental	Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced	Drug: Oxytocin
Placebo	Placebo Comparator	Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxytocin	Drug	oxytocin will be given intranasally. The order of administration will be counterbalanced	Oxytocin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PET	changes in [18F] flumazenil specific binding	90 minues
fMRI changes	changes in brain functional connectivity	90 minutes
MRS	Changes in brain chemistry measured using MRS	90 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Schizophrenia group

Inclusion Criteria:

Diagnosis of schizophrenia or schizoaffective disorder
Males between 18 and 45 years
capacity to provide informed consent

Exclusion Criteria:

current comorbid axis I diagnosis and no alcohol/substance abuse/dependence in the last 12 months (except nicotine)
Contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
Contraindication to MRI like implants/claustrophobia
Past history of head injury resulting in loss of consciousness or neurosurgery
Concomitant severe medical conditions
On treatment with benzodiazepine medications for at least 8 weeks
Contraindication to Positron emission tomography

Healthy volunteers

Inclusion Criteria:

Males between 18 and 45 years
capacity to provide informed consent

Exclusion Criteria:

Lifetime diagnosis of psychiatric illness including substance dependence
contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
contraindication to MRI like implants/claustrophobia
past history of head injury resulting in loss of consciousness or neurosurgery
concomitant severe medical conditions
on treatment with benzodiazepine medications for at least 8 weeks
contraindication to Positron emission tomography
Family history of schizophrenia, schizoaffective or schizophreniform disorder in family member

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

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones