Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Randomised Double Blind Placebo Controlled Study of Sodium Nitroprusside Added to Treatment as Usual in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548612
• Other study ID #: SNPSCZ001
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2012
• Last updated: March 7, 2012
• Start date: February 2006
• Est. completion date: December 2010

Study information

• Verified date: March 2012
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

In spite of the numerous studies on schizophrenia, its etiology and physiopathology remain unknown. Evidence suggests a possible implication of nitric oxide (NO) in schizophrenia. NO is a gas with unique chemistry and influences the release of neurotransmitters, learning, memory and neurodevelopment. Recent studies that investigated the role of NO in patients with schizophrenia found evidence that points to a disruption in NO-mediated neurotransmission in schizophrenia. Accordingly, we believe that the administration of sodium nitroprusside, an NO donor, will ameliorate schizophrenia symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of schizophrenia

• Patients in an acute psychotic episode requiring full hospitalization

Exclusion Criteria:

• Significant medical conditions (heart, kidney, liver, thyroid or neurological diseases, hypovitaminosis B12, hyponatremia)

• Pregnancy

• Breastfeeding

• Previous hypersensitivity to sodium nitroprusside

• DSM-IV diagnosis of drug abuse or dependence

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Sodium nitroprusside
Intravenous infusion of 0,5 mcg/kg/min for 240 minutes
• Glucose solution
Intravenous infusion of glucose solution 5% for 240 minutes

Locations

Country	Name	City	State
Brazil	University General Hospital of the Ribeirao Preto Medical School	Ribeirao Preto	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BPRS score	Brief Psychiatric Rating Scale	baseline and up to 4 weeks	No
Primary	Change in PANSS negative subscale score	Positive and Negative Syndrome Scale	Every hour for 4 hours, then at +12h, then daily for 7 days, then weekly for 4 weeks	No
Secondary	Cognitive assessment	FAS, 2-back, Stroop Color Word Test	Baseline and after 12 h	No