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
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia
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
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
No
Learn more about this trial
Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia
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