Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sodium nitroprusside

Group Type EXPERIMENTAL

Sodium nitroprusside

Intervention Type DRUG

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

Placebo

Glucose solution 5%

Group Type PLACEBO_COMPARATOR

Glucose solution

Intervention Type DRUG

Intravenous infusion of glucose solution 5% for 240 minutes

Interventions

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Sodium nitroprusside

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

Intervention Type DRUG

Glucose solution

Intravenous infusion of glucose solution 5% for 240 minutes

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No