Effect of Intranasal Vasopressin on Cooperative Behavior... | NCT04190004

Studies
Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia

NCT04190004

Sponsor

National Institute of Mental Health and Neuro Sciences, India

Status

Completed

Last Update Posted

Dec 9, 2019Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Schizophrenia

Interventions

Vasopressins
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

Dec 2019

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

Jan 1, 2018Actual

Primary Completion Date

Nov 30, 2018Actual

Completion Date

Nov 30, 2018Actual

First Submitted Date

Dec 3, 2019

First Submission Date that Met QC Criteria

Dec 5, 2019

First Posted Date

Dec 9, 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

Dec 5, 2019

Last Update Posted Date

Dec 9, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Naren P Rao, Additional Professor, National Institute of Mental Health and Neuro Sciences, IndiaPrincipal Investigator

Lead Sponsor

National Institute of Mental Health and Neuro Sciences, IndiaOTHER

Collaborators

Not provided

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

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vasopressin	Experimental	All subjects will receive bot 40IU of vasopressin and saline placebo in counterbalanced design	Drug: Vasopressins
Placebo	Placebo Comparator	All subjects will receive bot 40IU of vasopressin and saline placebo in counterbalanced design	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vasopressins	Drug	40 International units of vasopressin or placebo will be given intra-nasally. The order of the administration will be counterbalanced	vasopressin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Performance in Dictator game	Amount of money shared in dictator game	60 minutes
Performance in stag hunt game	Security level in stag hunt game	60 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-45 years
Diagnosed as Schizophrenia or Schizophreniform disorder as per DSM IV TR
At least 7 years of formal education
MOCA score >24

Exclusion Criteria:

Diagnoses of SIADH, Diabetes Insipidus
Substance dependence in the past 12 months, excluding nicotine dependence
Current comorbid axis 1 psychiatric disorder
Hypersensitivity or previous allergy to Vasopressin
Serious medical or neurological illness which may interfere with assessment and administration of vasopressin
Hypertension
Impaired renal functions based on serum creatinine above 1.5
Electrolyte imbalance
Receiving ECT or has received ECT in the past 8 weeks
Clinical history of mental retardation
Pregnancy • Lactation
Risk of harm to self or others
Any significant nasal pathology which may hinder the intranasal absorption of the drug
Hearing or visual impairment that significantly affects the comprehension and execution of the study

Accepts Healthy Volunteers

Sex

All

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Mental Health and Neurosciecnes		Bangalore	Karnataka	560029	India

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014667	Vasopressins

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided