Use of sodium nitroprusside and its effect on negative symptoms in treatment-resistant schizophrenia

Use of sodium nitroprusside in repeated doses, in potentiation of typical and atypical antipsychotics, and its effect on negative symptoms in treatment-resistant schizophrenia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-2zhgjw

Enrollment

Unknown

Registered

2019-03-01

Start date

2018-05-20

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Schizophrenia

Interventions

Intervention group: 10 subjects that will receive Sodium nitroprusside, that will be used in controlled continuous intravenous infusion at a dose of 0.5 ?g / kg / min, diluted 5% glucose solution for

Drug

Z45.1

D27.505.696.277.950.040

Eligibility

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Male or female gender; diagnosis of schizophrenia and antipsychotic treatment; be of legal age and be between the ages of 18 and 60; refractory population, ie patients who have used at least two typical or atypical antipsychotics, for at least 6 weeks each of the antipsychotics.

Exclusion criteria

Exclusion criteria: Relevant medical condition (cardiovascular diseases, neurological diseases, renal failure, liver disease, hypothyroidism, hyponatremia, hypovitaminosis B12, pregnancy, breastfeeding); history of hypersensitivity and / or allergy to sodium nitroprusside; diagnosis of substance abuse or dependence according to DSM-IV-TR criteria.

Design outcomes

Primary

Measure	Time frame
It is expected that with this medication intervention there will be a reduction in the negative symptomatology and respective clinical improvement of the patient, verified by a reduction in the total score of the BPRS and PANSS scales in 20%, specifically reduction of 20% in the negative sub-scale of PANSS. In addition, it will be verified whether this reduction will be statistically significant compared to the control group.	—

Measure

Time frame

It is expected that with this medication intervention there will be a reduction in the negative symptomatology and respective clinical improvement of the patient, verified by a reduction in the total score of the BPRS and PANSS scales in 20%, specifically reduction of 20% in the negative sub-scale of PANSS. In addition, it will be verified whether this reduction will be statistically significant compared to the control group.

—

Secondary

Measure	Time frame
To assess the tolerability of repeated administration of sodium nitroprusside in patients with treatment-resistant schizophrenia by assessing clinical parameters such as blood pressure, heart rate, and oxygen saturation, as well as assessing side effects through the UKU side effects scale to demonstrate that sodium nitroprusside is a safe and well tolerated medication and that the parameters have remained within an acceptable and non-clinically significant range.	—

Measure

Time frame

To assess the tolerability of repeated administration of sodium nitroprusside in patients with treatment-resistant schizophrenia by assessing clinical parameters such as blood pressure, heart rate, and oxygen saturation, as well as assessing side effects through the UKU side effects scale to demonstrate that sodium nitroprusside is a safe and well tolerated medication and that the parameters have remained within an acceptable and non-clinically significant range.

—

Countries

Brazil

Contacts

Public ContactMarcel Nunes

Instituto Bairral de Psiquiatria

marcelnunes59@yahoo.com.br+55(019)984102222

Outcome results

None listed

Source: REBEC (via WHO ICTRP)