Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Vasopressins; Drug: Placebo

• Registration Number: NCT04190004
• Lead Sponsor: National Institute of Mental Health and Neuro Sciences, India

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-12
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-05
• Last Update Submitted: 2019-12-05
• Study First Posted: 2019-12-09
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
vasopressin	Vasopressins	All subjects will receive bot 40IU of vasopressin and saline placebo in counterbalanced design
Placebo	Placebo	All subjects will receive bot 40IU of vasopressin and saline placebo in counterbalanced design

Primary Outcome Measures

Name	Time	Method
Performance in Dictator game	60 minutes	Amount of money shared in dictator game
Performance in stag hunt game	60 minutes	Security level in stag hunt game

Trial Locations

Locations (1)

National Institute of Mental Health and Neurosciecnes; 🇮🇳 Bangalore, Karnataka, India