Sodium Nitroprusside in Early Course Schizophrenia

NCT04986072 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: ALK3831-A309
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizoaffective Disorder; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Syndrome Scale (PANSS)

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

  Measured at hour 2

Study Arms (2)

Sodium Nitroprusside Arm

EXPERIMENTAL

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

Drug: Sodium Nitroprusside

Placebo Arm

PLACEBO COMPARATOR

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

Drug: 5% Dextrose solution

Interventions

5% Dextrose solution DRUG

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

Also known as: Placebo

Placebo Arm

Sodium Nitroprusside DRUG

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

Also known as: Active

Sodium Nitroprusside Arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Nitroprusside; Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ferricyanides; Cyanides; Anions; Ions; Electrolytes; Inorganic Chemicals; Ferric Compounds; Iron Compounds; Hydrogen Cyanide; Nitrogen Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Due to privacy concerns of single participant, data will not be shown for this outcome.

Results Point of Contact

• Title: Dr. Paulo Lizano MD, PhD
• Organization: University of Rochester Medical Center

lizanopl@gmail.com

(201) 776-6708

Study Officials

• Paulo Lizano, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 2, 2021
• Study Start: March 14, 2022
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 30, 2025
• Results First Posted: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)