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Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia

Primary Purpose

Schizophrenia

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Vasopressins

Placebo

About this trial

This is an interventional other trial for Schizophrenia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Institute of Mental Health and Neurosciecnes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

vasopressin

Placebo

Arm Description

All subjects will receive bot 40IU of vasopressin and saline placebo in counterbalanced design

Outcomes

Primary Outcome Measures

Performance in Dictator game

Amount of money shared in dictator game

Performance in stag hunt game

Security level in stag hunt game

Secondary Outcome Measures

Full Information

NCT ID

NCT04190004

First Posted

December 3, 2019

Last Updated

December 5, 2019

Sponsor

National Institute of Mental Health and Neuro Sciences, India

1. Study Identification

Unique Protocol Identification Number

NCT04190004

Brief Title

Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia

Official Title

Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

November 30, 2018 (Actual)

Study Completion Date

November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Institute of Mental Health and Neuro Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The study investigates the effect of 40IU of intranasal vasopressin on cooperative behavior in patients with schizophrenia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

After completion of clinical assessments all subjects will receive either 40 IU of vasopressin or saline in counterbalanced order on two separate days and perform the behavioral tasks

Masking

ParticipantInvestigator

Masking Description

Double

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vasopressin

Arm Type

Experimental

Arm Description

All subjects will receive bot 40IU of vasopressin and saline placebo in counterbalanced design

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

All subjects will receive bot 40IU of vasopressin and saline placebo in counterbalanced design

Intervention Type

Drug

Intervention Name(s)

Vasopressins

Intervention Description

40 International units of vasopressin or placebo will be given intra-nasally. The order of the administration will be counterbalanced

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

40 International units of vasopressin or placebo will be given intra-nasally. The order of the administration will be counterbalanced

Primary Outcome Measure Information:

Title

Performance in Dictator game

Description

Amount of money shared in dictator game

Time Frame

60 minutes

Title

Performance in stag hunt game

Description

Security level in stag hunt game

Time Frame

60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

National Institute of Mental Health and Neurosciecnes

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560029

Country

India

12. IPD Sharing Statement

Plan to Share IPD

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Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia

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