What side effects are associated with this type of intervention?

Common treatments for schizophrenia, such as antipsychotic medications, often have side effects including extrapyramidal symptoms (EPS), metabolic syndrome, weight gain, and sedation. Specific to treatments with vasodilation and anti-inflammatory effects, such as Sodium Nitroprusside (SNP), potential side effects may include hypotension, dizziness, and headaches. Anti-inflammatory agents like aspirin, while generally well-tolerated, can cause gastrointestinal issues and increased bleeding risk. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, including both first-generation (e.g., haloperidol) and second-generation antipsychotics (e.g., clozapine, risperidone, olanzapine). While these drugs primarily target dopamine receptors to alleviate psychotic symptoms, there is growing interest in adjunctive treatments with anti-inflammatory properties. For instance, studies have explored the use of anti-inflammatory agents like omega-3 fatty acids and other medications that may reduce peripheral inflammation. Sodium Nitroprusside (SNP), known for its vasodilatory and potential anti-inflammatory effects, is currently being studied for its efficacy in early course schizophrenia, although it has not yet received FDA approval for this indication.

What other types of research exist?

Promising novel alternatives to Sodium Nitroprusside (SNP) for schizophrenia patients include phenylcyanoguanidine derivatives, such as N-(3-chloro-5-cyanophenyl)-N'-cyano-N"-tert-pentylguanidine (5s), which exhibits strong smooth muscle relaxation and antihypertensive effects. Another potential alternative is Vanidil, a nonvolatile organic solid nitrate with antiangina properties and the ability to inhibit coronary vasospasm.

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Sodium Nitroprusside for Schizophrenia

Phase 2

Waitlist Available

Led By Paulo Lizano, MD, PhD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Having unstable major medical (renal, hepatic, or cardiac) or neurologic illness

Having significant inflammatory or immune conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at hour 5

Summary

This trial is testing Sodium Nitroprusside (SNP), a medication that widens blood vessels, on patients with early-stage schizophrenia who have high inflammation. The goal is to see if it can reduce inflammation and improve brain blood flow, potentially helping with schizophrenia symptoms. Sodium nitroprusside (SNP) has been reported to rapidly reduce psychotic symptoms and improve cognitive functions in patients with schizophrenia.

Who is the study for?

This trial is for English-speaking individuals diagnosed with Schizophrenia or schizoaffective disorder within the last 5 years, who have experienced psychosis and are not extensively treated with antipsychotics. They must be able to consent and score above a threshold on a symptom scale. Excluded are those on clozapine, certain other medications, pregnant/breastfeeding women, people with major illnesses or retinal disease, recent substance abuse, or medication changes.

What is being tested?

The study tests Sodium Nitroprusside's effectiveness against schizophrenia symptoms compared to a standard solution (5% Dextrose). It aims to see if this drug can improve psychosis symptoms, cognitive functions, and specific eye vessel conditions in patients at an early stage of their illness.

What are the potential side effects?

Sodium Nitroprusside may cause low blood pressure when standing up (orthostatic hypotension), potential allergic reactions in some individuals intolerant to it previously. Other side effects could include issues related to its anti-inflammatory properties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have used antipsychotic medications for up to 2 years.

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My schizophrenia symptoms are severe, scoring over 65 on PANSS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unstable major illnesses like kidney, liver, heart, or brain conditions.

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I have a significant immune or inflammatory condition.

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I haven't changed my mental health medications in the last 4 weeks.

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I am currently taking clozapine.

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I have a history of eye disease, severe nearsightedness, or dizziness when standing up.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at hour 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at hour 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at hour 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Positive and Negative Syndrome Scale (PANSS)

Secondary study objectives

Brief Assessment of Cognition in Schizophrenia (BACS)

Inflammatory Markers

SS-OCTA Retinal Imaging

Side effects data

From 2009 Phase 1 trial • 62 Patients • NCT00945256

Redness at biopsy site

Back Pain

Cellulitis

100%

80%

60%

40%

20%

Study treatment Arm

Elderly Sodium Nitroprusside

Elderly Sodium Nitroprusside and Amino Acid Drink

Young Aerobic Exercise

Elderly Aerobic Exercise

Young Sodium Nitroprusside

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Sodium Nitroprusside ArmExperimental Treatment1 Intervention

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

Group II: Placebo ArmPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sodium Nitroprusside

2018

Completed Phase 1

~240

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for schizophrenia primarily involve antipsychotic medications that target dopamine D2 receptors to reduce psychotic symptoms by modulating dopamine activity in the brain. Some treatments also affect serotonin receptors, which can help with both positive and negative symptoms. The importance of these mechanisms lies in their ability to alleviate symptoms such as hallucinations, delusions, and disorganized thinking, thereby improving patients' quality of life. Sodium Nitroprusside (SNP) is being studied for its vasodilatory and potential anti-inflammatory effects, which may address underlying microvascular dysfunction and inflammation in schizophrenia. This could offer a novel approach to treatment by targeting different aspects of the disease's pathophysiology, potentially leading to better outcomes for patients.

The past and future of novel, non-dopamine-2 receptor therapeutics for schizophrenia: A critical and comprehensive review.