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Completed

NCT Number: NCT04190004

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Mental Health and Neurosciecnes

Bangalore, Karnataka, 560029, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vasopressins

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Performance in Dictator game

    Time frame: 60 minutes

    Amount of money shared in dictator game

  2. Performance in stag hunt game

    Time frame: 60 minutes

    Security level in stag hunt game

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health and Neuro Sciences, India

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 9, 2019
Registry last updated
Dec 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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