Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia

Randomised Double Blind Placebo Controlled Study of Sodium Nitroprusside Added to Treatment as Usual in Patients With Schizophrenia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01548612

Enrollment

Registered

2012-03-08

Start date

2006-02-28

Completion date

2010-12-31

Last updated

2012-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, Nitric oxide, Sodium nitroprusside

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.

Interventions

DRUGSodium nitroprusside

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

DRUGGlucose solution

Intravenous infusion of glucose solution 5% for 240 minutes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change in BPRS score	baseline and up to 4 weeks	Brief Psychiatric Rating Scale
Change in PANSS negative subscale score	Every hour for 4 hours, then at +12h, then daily for 7 days, then weekly for 4 weeks	Positive and Negative Syndrome Scale

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026