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Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01548612
First Posted: March 8, 2012
Last Update Posted: March 8, 2012
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.
Information provided by (Responsible Party):
Jaime Eduardo Cecilio Hallak, University of Sao Paulo
  Purpose
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.

Condition Intervention Phase
Schizophrenia Drug: Sodium nitroprusside Drug: Glucose solution Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomised Double Blind Placebo Controlled Study of Sodium Nitroprusside Added to Treatment as Usual in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Jaime Eduardo Cecilio Hallak, University of Sao Paulo:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Cognitive assessment [ Time Frame: Baseline and after 12 h ]
    FAS, 2-back, Stroop Color Word Test


Enrollment: 20
Study Start Date: February 2006
Study Completion Date: December 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium nitroprusside Drug: Sodium nitroprusside
Intravenous infusion of 0,5 mcg/kg/min for 240 minutes
Placebo Comparator: Placebo
Glucose solution 5%
Drug: Glucose solution
Intravenous infusion of glucose solution 5% for 240 minutes

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548612


Locations
Brazil
University General Hospital of the Ribeirao Preto Medical School
Ribeirao Preto, SP, Brazil, 14048-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Jaime EC Hallak, Doctor Ribeirao Preto Medical School, University of Sao Paulo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jaime Eduardo Cecilio Hallak, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01548612     History of Changes
Other Study ID Numbers: SNPSCZ001
First Submitted: February 13, 2012
First Posted: March 8, 2012
Last Update Posted: March 8, 2012
Last Verified: March 2012

Keywords provided by Jaime Eduardo Cecilio Hallak, University of Sao Paulo:
Schizophrenia
Nitric oxide
Sodium nitroprusside

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Pharmaceutical Solutions
Nitroprusside
Antihypertensive Agents
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action