Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Vasopressins; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560029
      • National Institute of Mental Health and Neurosciecnes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vasopressin; All subjects will receive bot 40IU of vasopressin and saline placebo in counterbalanced design	Drug: Vasopressins; 40 International units of vasopressin or placebo will be given intra-nasally. The order of the administration will be counterbalanced
Placebo Comparator: Placebo; All subjects will receive bot 40IU of vasopressin and saline placebo in counterbalanced design	Drug: Placebo; 40 International units of vasopressin or placebo will be given intra-nasally. The order of the administration will be counterbalanced

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: National Institute of Mental Health and Neuro Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): December 9, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Vasoconstrictor Agents; Antidiuretic Agents; Vasopressins; Arginine Vasopressin
• Other Study ID Numbers: IEC/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No