Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia

March 7, 2012 updated by: Jaime Eduardo Cecilio Hallak, University of Sao Paulo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Ribeirao Preto, SP, Brazil, 14048-900
        • University General Hospital of the Ribeirao Preto Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BPRS score
Time Frame: baseline and up to 4 weeks
Brief Psychiatric Rating Scale
baseline and up to 4 weeks
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
Every hour for 4 hours, then at +12h, then daily for 7 days, then weekly for 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive assessment
Time Frame: Baseline and after 12 h
FAS, 2-back, Stroop Color Word Test
Baseline and after 12 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Jaime EC Hallak, Doctor, Ribeirão Preto Medical School, University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 13, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (Estimate)

March 8, 2012

Study Record Updates

Last Update Posted (Estimate)

March 8, 2012

Last Update Submitted That Met QC Criteria

March 7, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNPSCZ001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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