Sodium Nitroprusside in Early Course Schizophrenia (NCT04986072) | Clinical Trial Compass
TerminatedPhase 2
Sodium Nitroprusside in Early Course Schizophrenia
Stopped: Difficulty with recruiting subjects for the study
United States1 participantsStarted 2022-03-14
Plain-language summary
Peripheral inflammation and microvascular dysfunction are central to the pathophysiology of schizophrenia (SZ). Retinal imaging allows for the accurate quantitative assessment of the condition of retinal microvessels, and early studies implicate microvascular dysfunction in SZ, but the specific pathophysiological mechanisms underlying greater length, density, capillary network and diameter are not yet entirely understood. Anti-inflammatory drug trials in SZ suggest that Early Course Schizophrenia (ECS) individuals with elevated peripheral inflammation show the greatest benefit to adjunctive anti inflammatory treatments. Also, there is a growing interest in the use of Sodium Nitroprusside (SNP) in SZ but further studies are needed as results are inconsistent. This study will determine the effectiveness of SNP on psychosis symptoms, cognition, and retinal measures in symptomatic ECS.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Having a DSM-V diagnosis of Schizophrenia or schizoaffective disorder with \<5 years from the onset of psychosis
* Having up to 2 years of lifetime exposure to antipsychotics
* Having total score of \>65 on the Positive and Negative Syndrome Scale (PANSS) with a score of \>4 on 1 or more PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, or unusual thought content)
* Having English proficiency
* Being competent and willing to give informed consent
Exclusion Criteria:
* Having substance dependence or abuse within the past 6 months
* Having history of retinal disease; myopia \>4.0 diopters; symptomatic orthostatic hypotension
* Any change of psychotropic medications within the previous 4 weeks
* Currently taking clozapine
* Having prior history of intolerance to Sodium Nitroprusside
* Having treatment with medications that may interfere with the metabolism or excretion or effects of Sodium Nitroprusside
* Being pregnancy/breast feeding
* Having unstable major medical (renal, hepatic, or cardiac) or neurologic illness
* Having significant inflammatory or immune conditions
* Having treatment with anti-inflammatory drugs, hormones or immunosuppressant agents in the 6 months before study entry.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.