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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
Awards & highlights
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 belowSelect...
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:Select...
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.
Select...
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
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 • NCT009452566%
Redness at biopsy site
6%
Back Pain
6%
Cellulitis
100%
80%
60%
40%
20%
0%
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
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.
The past and future of novel, non-dopamine-2 receptor therapeutics for schizophrenia: A critical and comprehensive review.
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
852 Previous Clinical Trials
12,930,632 Total Patients Enrolled
22 Trials studying Schizophrenia
2,270 Patients Enrolled for Schizophrenia
Paulo Lizano, MD, PhDPrincipal InvestigatorBeth Israel Deaconess Medical Center
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on medications that affect Sodium Nitroprusside.I do not have any unstable major illnesses like kidney, liver, heart, or brain conditions.I have a significant immune or inflammatory condition.I have used antipsychotic medications for up to 2 years.I haven't changed my mental health medications in the last 4 weeks.I am currently taking clozapine.I was diagnosed with Schizophrenia or schizoaffective disorder less than 5 years ago.I understand the study and agree to participate.I have a history of eye disease, severe nearsightedness, or dizziness when standing up.My schizophrenia symptoms are severe, scoring over 65 on PANSS.I haven't taken anti-inflammatory drugs, hormones, or immunosuppressants in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Arm
- Group 2: Sodium Nitroprusside Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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