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Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Sodium nitroprusside
Glucose solution
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Nitric oxide, Sodium nitroprusside

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University General Hospital of the Ribeirao Preto Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sodium nitroprusside

Placebo

Arm Description

Glucose solution 5%

Outcomes

Primary Outcome Measures

Change in BPRS score
Brief Psychiatric Rating Scale
Change in PANSS negative subscale score
Positive and Negative Syndrome Scale

Secondary Outcome Measures

Cognitive assessment
FAS, 2-back, Stroop Color Word Test

Full Information

First Posted
February 13, 2012
Last Updated
March 7, 2012
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01548612
Brief Title
Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia
Official Title
Randomised Double Blind Placebo Controlled Study of Sodium Nitroprusside Added to Treatment as Usual in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Nitric oxide, Sodium nitroprusside

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium nitroprusside
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Glucose solution 5%
Intervention Type
Drug
Intervention Name(s)
Sodium nitroprusside
Intervention Description
Intravenous infusion of 0,5 mcg/kg/min for 240 minutes
Intervention Type
Drug
Intervention Name(s)
Glucose solution
Intervention Description
Intravenous infusion of glucose solution 5% for 240 minutes
Primary Outcome Measure Information:
Title
Change in BPRS score
Description
Brief Psychiatric Rating Scale
Time Frame
baseline and up to 4 weeks
Title
Change in PANSS negative subscale score
Description
Positive and Negative Syndrome Scale
Time Frame
Every hour for 4 hours, then at +12h, then daily for 7 days, then weekly for 4 weeks
Secondary Outcome Measure Information:
Title
Cognitive assessment
Description
FAS, 2-back, Stroop Color Word Test
Time Frame
Baseline and after 12 h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime EC Hallak, Doctor
Organizational Affiliation
Ribeirao Preto Medical School, University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University General Hospital of the Ribeirao Preto Medical School
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14048-900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
23699763
Citation
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.
Results Reference
derived

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Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia

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