Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia

NCT04190004 | Completed

• 1 other identifier: IEC/2017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

vasopressin

EXPERIMENTAL

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

Drug: Vasopressins

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Vasopressins DRUG

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

vasopressin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

National Institute of Mental Health and Neurosciecnes

Bangalore, Karnataka, 560029, India

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Vasopressins

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Model Details: 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

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 9, 2019
• Study Start: January 1, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: December 9, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)