Sodium Nitroprusside in Early Course Schizophrenia
Key facts
- Who runs it
- Beth Israel Deaconess Medical Center
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 1 person enrolled
- Started
- 14 Mar 2022
- Ended
- 1 Jul 2024
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Sodium Nitroprusside
- 5% Dextrose solution
- Record updated
- 30 December 2025
- Why it stopped
- Difficulty with recruiting subjects for the study
Who can take part
- Age
- 18 years to 40 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Any change of psychotropic medications within the previous 4 weeks
- Currently taking clozapine
- Having treatment with anti-inflammatory drugs, hormones or immunosuppressant agents in the 6 months before study entry
- Having history of retinal disease; myopia >4.0 diopters; symptomatic orthostatic hypotension
- Having unstable major medical (renal, hepatic, or cardiac) or neurologic illness
- Having significant inflammatory or immune conditions
- 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
- Having substance dependence or abuse within the past 6 months
- Being pregnancy/breast feeding
Where in United States
- Beth Israel Deaconess Medical CenterBoston, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Sodium Nitroprusside ArmTreatment being tested
Sodium Nitroprusside (0.5 μg/kg/min) for 4 hours
Treatment: Sodium Nitroprusside
- Placebo ArmPlacebo, for comparison
5% Dextrose (0.5 μg/kg/min) for 4 hours
Treatment: 5% Dextrose solution
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Proof of Mechanism Study Using a Retinal Biomarker to Predict Treatment Response With Intravenous Sodium Nitroprusside in Symptomatic Early Course Schizophrenia
- Record updated
- 30 December 2025