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TerminatedNCT04986072Updated Dec 30, 2025Results posted

Sodium Nitroprusside in Early Course Schizophrenia

A Phase 2 interventional study of Sodium Nitroprusside and 5% Dextrose solution in Schizophrenia and Schizoaffective Disorder, sponsored by Beth Israel Deaconess Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-12-30.

Sponsored by Beth Israel Deaconess Medical Center · Phase 2, Interventional, and Treatment

Why this study was terminated
Difficulty with recruiting subjects for the study
Phase
Phase 2
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
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Study 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.

Read the detailed description

The microvascular environment is the major interface of systemic factors affecting the brain, it is a logical focus for understanding the neurobiology of schizophrenia (SZ). However, our understanding of the immunological underpinnings of SZ and improved methodologies to detect microvascular disorder have led to increased research in this area. We have shown that inflammatory subtypes are found in psychosis and an increased pattern of peripheral inflammation (including C-Reactive Protein, CRP) is related with worse overall cognition. Retinal and cerebral microvessels are embryological related and can be utilized to measure the state of cerebral microvessels. Advances in retinal imaging, such as swept source optical coherence tomography angiography (SS-OCTA), provide greater microvascular clarity to visualize the retina non-invasively, in a more detailed, quicker and cost-effective manner. In a pilot study using SS-OCTA, we identified microvascular dysfunction associated with early-stages SZ. The pathophysiological mechanisms underlying these retinal microvascular changes are not entirely understood, but they have been associated with inflammation (including CRP), endothelial dysfunction, reactive oxygen species and hypoxia/ ischemia, which have also been consistently observed in SZ. Nitric oxide (NO) signaling is a potential mechanism for protecting the microvasculature against oxidative stress, inflammation and endothelial dysfunction and treatment with NOD have been shown to reduce oxidative stress/inflammation and to increase cerebral blood flow in cerebrovascular disorders. 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. In line with that there is a growing interest in the use of SNP in SZ. Preclinical and clinical evidence have shown that SNP may have an antipsychotic profile. Hallak et al (2013) demonstrated that a single infusion of SNP in patients with ECS was both safe and associated with immediate and longer-term clinical outcome. While three other studies demonstrated that SNP was well-tolerated in patient with multi-episode SZ, they were not able to replicate Hallak's finding, which was likely due to the disease heterogeneity, the inclusion of an older population with a longer duration or multi-episodes of illness, and the lack of treatment biomarkers. Further work is needed to determine whether the effect of SNP treatment is dependent on a patient's illness duration and whether a retinal biomarker for microvascular dysfunction/inflammation can predict treatment response to SNP. Thus, the principal goal in the field of SZ is to identify biomarker-based targets for early intervention, evidence of engaging this target by selective interventions and assessing therapeutic efficacy.

02

Conditions studied

  • Schizophrenia
  • Schizoaffective Disorder
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 1 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Sodium Nitroprusside Arm

    Sodium Nitroprusside (0.5 μg/kg/min) for 4 hours

    Drug: Sodium Nitroprusside

  • Placebo comparator
    Placebo Arm

    5% Dextrose (0.5 μg/kg/min) for 4 hours

    Drug: 5% Dextrose solution

Interventions

  • DrugSodium Nitroprusside

    Half of participants will receive Intravenous Sodium Nitroprusside (0.5 μg/kg/min) for 4 hours.

    Also known as: Active

  • Drug5% Dextrose solution

    Half of participants will receive intravenous 5% Dextrose solution for 4 hours.

    Also known as: Placebo

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What researchers measure

Primary outcomes

  1. Positive and Negative Syndrome Scale (PANSS)

    Comparing total, positive, and negative scores between SNP and Placebo

    Time frame: Measured at hour 2

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Results

Posted Dec 10, 2025
Limitations and caveats
Due to privacy concerns of single participant, data will not be shown for this outcome.

Participant flow

study terminated sue to low recruitment

Participant flow — Overall Study
MilestoneSodium Nitroprusside ArmPlacebo Arm
Started01
Completed01
Not completed00

Outcome measures

PrimaryPositive and Negative Syndrome Scale (PANSS)

Comparing total, positive, and negative scores between SNP and Placebo

Time frame:
Measured at hour 2

No measurements were reported for this outcome.

Adverse events

Collected over Adverse event data was collect up to 4 weeks after intervention. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sodium Nitroprusside Arm———
Placebo Arm0/1 (0%)0/1 (0%)0/1 (0%)

Baseline characteristics

Study Terminated due to low enrollment

Age, Customized
Age, Customized(Participants)Sodium Nitroprusside ArmPlacebo ArmTotal
Due to privacy concerns of single participant, data will not be shown for this outcome—NANA
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Sodium Nitroprusside ArmPlacebo ArmTotal
Due to privacy concerns of single participant, data will not be shown for this outcome—NANA
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Sodium Nitroprusside ArmPlacebo ArmTotal
Hispanic or Latino—00
Not Hispanic or Latino—00
Unknown or Not Reported—11
Region of Enrollment
Region of Enrollment(participants)Sodium Nitroprusside ArmPlacebo ArmTotal
United States—11
PANSS Total Score
PANSS Total Score(score on scale)Sodium Nitroprusside ArmPlacebo ArmTotal
Number—NA0
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Study locations

1 site
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 17, 2023
  • Informed consent form · Sep 17, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04986072
Lead sponsor
Beth Israel Deaconess Medical Center
Responsible party
Paulo Lizano (Assistant Professor, Beth Israel Deaconess Medical Center) — Principal investigator
First posted
Aug 2, 2021
Start date
Mar 14, 2022
Primary completion
Jun 1, 2024
Completion
Jul 1, 2024
Results posted
Dec 10, 2025
Last update
Dec 30, 2025

Study contacts

Paulo Lizano, MD, PhD
principal investigator · Beth Israel Deaconess Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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