Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia

• Sponsor: National Institute of Mental Health and Neuro Sciences, India (Other)
• Overall Status: Completed
• CT.gov ID: NCT04190004
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.9
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Vasopressins; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: 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 tasksAfter 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
• Masking: Double (Participant, Investigator)
• Masking Description: Double
• Primary Purpose: Other
• Official Title: Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Nov 30, 2018
• Actual Study Completion Date: Nov 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Performance in Dictator game [60 minutes]

   Amount of money shared in dictator game

2. Performance in stag hunt game [60 minutes]

   Security level in stag hunt game

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Mental Health and Neurosciecnes	Bangalore	Karnataka	India	560029

Sponsors and Collaborators

• National Institute of Mental Health and Neuro Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Naren P Rao, Additional Professor, National Institute of Mental Health and Neuro Sciences, India
• ClinicalTrials.gov Identifier: NCT04190004
• Other Study ID Numbers: IEC/2017
• First Posted: Dec 9, 2019
• Last Update Posted: Dec 9, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Schizophrenia; Vasopressins; Arginine Vasopressin

Study Results

No Results Posted as of Dec 9, 2019