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Sodium Nitroprusside for Schizophrenia

Phase 2

Recruiting

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at hour 5

Awards & highlights

Study Summary

This trial will determine the effectiveness of the drug Sodium Nitroprusside on psychosis symptoms, cognition, and retinal measures in symptomatic Early Course Schizophrenia patients.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Positive and Negative Syndrome Scale (PANSS)

Secondary outcome measures

Brief Assessment of Cognition in Schizophrenia (BACS)

Inflammatory Markers

SS-OCTA Retinal Imaging

Side effects data

From 2009 Phase 1 trial • 62 Patients • NCT00945256

Back Pain

Redness at biopsy site

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

~220

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

837 Previous Clinical Trials

13,010,240 Total Patients Enrolled

21 Trials studying Schizophrenia

1,970 Patients Enrolled for Schizophrenia

Paulo Lizano, MD, PhDPrincipal InvestigatorBeth Israel Deaconess Medical Center

1 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

Sodium Nitroprusside Clinical Trial Eligibility Overview. Trial Name: NCT04986072 — Phase 2

Schizophrenia Research Study Groups: Placebo Arm, Sodium Nitroprusside Arm

Schizophrenia Clinical Trial 2023: Sodium Nitroprusside Highlights & Side Effects. Trial Name: NCT04986072 — Phase 2

Sodium Nitroprusside 2023 Treatment Timeline for Medical Study. Trial Name: NCT04986072 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people who are under 40 years old take part in this research?

"The age limit for patients participating in this study is 18-40 years old."

Answered by AI

Are there any health hazards associated with Sodium Nitroprusside?

"Sodium Nitroprusside received a score of 2 on our team's 1-to-3 scale. This is because, while there is data attesting to its safety, there is currently no known efficacy for this medication."

Answered by AI

Are there precedent studies that suggest Sodium Nitroprusside is effective?

"There are currently 15 active trials researching the effects of Sodium Nitroprusside. Of these, 2 are in Phase 3. Some of the trial locations for Sodium Nitroprusside include Salt Lake City, Utah as well as 222 other sites."

Answered by AI

What medical conditions respond well to Sodium Nitroprusside?

"Sodium Nitroprusside is commonly used to treat dehydration, but it can also be helpful for managing diarrhea, surgical procedures, and fluid therapy."

Answered by AI

Might I be eligible to take part in this experiment?

"This study is looking for 32 individuals aged 18-40 that have been diagnosed with schizophrenia according to the DSM-V. To be eligible, participants cannot have had more than 5 years of exposure to antipsychotics and must have a total score of >65 on the Positive and Negative Syndrome Scale (PANSS). A score of >4 on at least one PANSS item related to delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, or unusual thought content is also required."

Answered by AI

How many individuals are being given this medication as part of the trial?

"Yes, the trial is still open and looking for patients. According to information on clinicaltrials.gov, the study was first posted on 3/14/2022 and was last updated on 4/7/2022. They are hoping to enroll 32 patients at a single site."

Answered by AI

Are new patients still being accepted into this clinical trial?

"Yes, this trial is still open to patients as of today. According to the listing on clinicaltrials.gov, the study was first posted on March 14th, 2020 and edited April 7th, 2020."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sodium Nitroprusside in Early Course Schizophrenia

Paulo Lizano 2022. "Sodium Nitroprusside in Early Course Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04986072.

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