Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia

National Institute of Mental Health and Neuro Sciences, India

Status: Completed

Conditions: Schizophrenia

Treatments: Drug: Vasopressins; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04190004

IEC/2017

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

vasopressin

Experimental group

Description:

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

Treatment:

Drug: Vasopressins

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo