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Clinical Trials/NCT04190004
NCT04190004CompletedNot Applicable

Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia

National Institute of Mental Health and Neuro Sciences, India1 site in 1 country30 target enrollmentStarted: January 1, 2018Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Performance in Dictator game
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Masking Description

Double

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

vasopressin

Experimental

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

Intervention: Vasopressins (Drug)

Placebo

Placebo Comparator

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

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Performance in Dictator game

Time Frame: 60 minutes

Amount of money shared in dictator game

Performance in stag hunt game

Time Frame: 60 minutes

Security level in stag hunt game

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
National Institute of Mental Health and Neuro Sciences, India
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Naren P Rao

Additional Professor

National Institute of Mental Health and Neuro Sciences, India

Study Sites (1)

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