Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia

University of Sao Paulo

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Glucose solution; Drug: Sodium nitroprusside

Study type: Interventional

Funder types: Other

Identifiers

NCT01548612

SNPSCZ001

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Sodium nitroprusside

Experimental group

Treatment:

Drug: Sodium nitroprusside

Placebo

Placebo Comparator group

Description:

Glucose solution 5%

Treatment:

Drug: Glucose solution