Schizophrenia
Conditions
Interventions
Isosorbide mononitrate 50mg orally for four weeks. The 15 patients starting the medication will, after four weeks, use placebo (identical tablet, without the medication inside, orally) for another fou
One day before starting the tablets, after four weeks and at the end of the eighth week.
Drug
Sponsors
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
Instituto Nacional de Ciência e Tecnologia Translacional em Medicina
Eligibility
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Patients of both sexes, age between 18 and 50 years, diagnosis of schizophrenia, in outpatient antipsychotic treatment without modifications in the last month and with symptoms present in the positive or negative dimensions.
Exclusion criteria
Exclusion criteria: Presence of relevant medical condition, such as cardiovascular diseases, severe hypertension, renal failure, liver disease, hypothyroidism, hyponatremia, B12 hypovitaminosis, previous intracranial hypertension, epilepsy, pregnancy, breastfeeding). This also includes patients who have signs and symptoms suggestive of hypotension such as blurred vision, dizziness, pallor, and cold extremities. History of hypersensitivity to organic nitrates. Diagnosis of substance use disorder according to DSM criteria, except nicotine. Patients with severe psychiatric comorbidities and who are the focus of clinical care in the recruitment period, such as major depressive episode and obsessive compulsive disorder. Patients with clinical criteria for integral hospitalization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reductions in PANSS(positive and negative symptoms scale), CGI (clinical global impression) and increases in MCCB (matrics cognitive consensual battery) scores; verified by the application of each scale; from the observation of the variation of 1 point in the PANSS negative or positive and CGI and by a statistically significant increase, any value, in the MCCB. We will analyze the primary outcomes weekly until the trial end. | — |
Secondary
| Measure | Time frame |
|---|---|
| Modifications in functional MRI (magnetic resonance imaging) patterns, verified by the analysis of the cerebral functioning maps between the groups and over time, as evidenced by differences in relation to the baseline. We will analyze the secondary outcomes twice; at the end of the first month and at the end of the second month. | — |
Countries
Brazil
Contacts
Public ContactTiago Guimaraes
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
Outcome results
None listed