NCT01548612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 schizophrenia

Timeline
Completed

Started Feb 2006

Longer than P75 for phase_2 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

3.3 years

First QC Date

February 13, 2012

Last Update Submit

March 7, 2012

Conditions

Schizophrenia

Keywords

SchizophreniaNitric oxideSodium nitroprusside

Outcome Measures

Primary Outcomes (2)

  • Change in BPRS score

    Brief Psychiatric Rating Scale

    baseline and up to 4 weeks

  • Change in PANSS negative subscale score

    Positive and Negative Syndrome Scale

    Every hour for 4 hours, then at +12h, then daily for 7 days, then weekly for 4 weeks

Secondary Outcomes (1)

  • Cognitive assessment

    Baseline and after 12 h

Study Arms (2)

Sodium nitroprusside

EXPERIMENTAL
Drug: Sodium nitroprusside

Placebo

PLACEBO COMPARATOR

Glucose solution 5%

Drug: Glucose solution

Interventions

Sodium nitroprussideDRUG

Intravenous infusion of 0,5 mcg/kg/min for 240 minutes

Sodium nitroprusside
Glucose solutionDRUG

Intravenous infusion of glucose solution 5% for 240 minutes

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of schizophrenia
  • Patients in an acute psychotic episode requiring full hospitalization

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University General Hospital of the Ribeirao Preto Medical School

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 23699763DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Nitroprusside

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

FerricyanidesCyanidesAnionsIonsElectrolytesInorganic ChemicalsFerric CompoundsIron CompoundsHydrogen CyanideNitrogen Compounds

Study Officials

  • Jaime EC Hallak, Doctor

    Ribeirao Preto Medical School, University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2012

First Posted

March 8, 2012

Study Start

February 1, 2006

Primary Completion

June 1, 2009

Study Completion

December 1, 2010

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

BR(1)