Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Sodium nitroprusside; Drug: Glucose solution

• Registration Number: NCT01548612
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2009-06
• Study Completion: 2010-12
• Study First Submitted: 2012-02-13
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-07
• Last Update Submitted: 2012-03-07
• Study First Posted: 2012-03-08
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium nitroprusside	Sodium nitroprusside	-
Placebo	Glucose solution	Glucose solution 5%

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Cognitive assessment	Baseline and after 12 h	FAS, 2-back, Stroop Color Word Test

Trial Locations

Locations (1)

University General Hospital of the Ribeirao Preto Medical School; 🇧🇷 Ribeirao Preto, SP, Brazil