se of sodium nitroprusside and its effect on negative symptoms in treatment-resistant schizophrenia
Phase 3
- Conditions
- SchizophreniaF03.700.750
- Registration Number
- RBR-2zhgjw
- Lead Sponsor
- niversidade Federal de São Paulo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.