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Completed

NCT Number: NCT01548612

Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia

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.

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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

Phase 2

Primary location

University General Hospital of the Ribeirao Preto Medical School

Ribeirão Preto, São Paulo, 14048-900, Brazil

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Sodium Nitroprusside

Drug

Intravenous infusion of 0,5 mcg/kg/min for 240 minutes

Glucose solution

Drug

Intravenous infusion of glucose solution 5% for 240 minutes

Primary outcomes

  1. Change in BPRS score

    Time frame: baseline and up to 4 weeks

    Brief Psychiatric Rating Scale

  2. Change in PANSS negative subscale score

    Time frame: Every hour for 4 hours, then at +12h, then daily for 7 days, then weekly for 4 weeks

    Positive and Negative Syndrome Scale

Secondary outcomes

  1. Cognitive assessment

    Time frame: Baseline and after 12 h

    FAS, 2-back, Stroop Color Word Test

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Mar 8, 2012
Registry last updated
Mar 8, 2012

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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