Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01548612
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : March 8, 2012
Information provided by (Responsible Party):
Jaime Eduardo Cecilio Hallak, University of Sao Paulo

February 13, 2012
March 8, 2012
March 8, 2012
February 2006
June 2009   (Final data collection date for primary outcome measure)
  • Change in BPRS score [ Time Frame: baseline and up to 4 weeks ]
    Brief Psychiatric Rating Scale
  • 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
Same as current
No Changes Posted
Cognitive assessment [ Time Frame: Baseline and after 12 h ]
FAS, 2-back, Stroop Color Word Test
Same as current
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Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia
Randomised Double Blind Placebo Controlled Study of Sodium Nitroprusside Added to Treatment as Usual in Patients With 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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Drug: Sodium nitroprusside
    Intravenous infusion of 0,5 mcg/kg/min for 240 minutes
  • Drug: Glucose solution
    Intravenous infusion of glucose solution 5% for 240 minutes
  • Experimental: Sodium nitroprusside
    Intervention: Drug: Sodium nitroprusside
  • Placebo Comparator: Placebo
    Glucose solution 5%
    Intervention: Drug: Glucose solution
Hallak JE, Maia-de-Oliveira JP, Abrao J, Evora PR, Zuardi AW, Crippa JA, Belmonte-de-Abreu P, Baker GB, Dursun SM. Rapid improvement of acute schizophrenia symptoms after intravenous sodium nitroprusside: a randomized, double-blind, placebo-controlled trial. JAMA Psychiatry. 2013 Jul;70(7):668-76. doi: 10.1001/jamapsychiatry.2013.1292.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2010
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Jaime Eduardo Cecilio Hallak, University of Sao Paulo
University of Sao Paulo
Not Provided
Principal Investigator: Jaime EC Hallak, Doctor Ribeirao Preto Medical School, University of Sao Paulo
University of Sao Paulo
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP