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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 University of Sao Paulo:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Cognitive assessment [ Time Frame: Baseline and after 12 h ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Sao Paulo

Additional 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
Study First Received: February 13, 2012
Last Updated: March 7, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo:
Schizophrenia
Nitric oxide
Sodium nitroprusside

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Nitroprusside
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 22, 2014