Proof of Mechanism Study Using a Retinal Biomarker to Predict Treatment Response With Intravenous Sodium Nitroprusside in Symptomatic Early Course Schizophrenia

ALK3831-A309

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.

2022-03-14

2024-12-21

2024-12-22

Recruiting

Early phase I

32

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: * 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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2023-05-15