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Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jaime Eduardo Cecilio Hallak, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01548612
First received: February 13, 2012
Last updated: March 7, 2012
Last verified: March 2012

February 13, 2012
March 7, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Positive and Negative Syndrome Scale
Same as current
Complete list of historical versions of study NCT01548612 on ClinicalTrials.gov Archive Site
Cognitive assessment [ Time Frame: Baseline and after 12 h ] [ Designated as safety issue: No ]
FAS, 2-back, Stroop Color Word Test
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01548612
SNPSCZ001
Yes
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