Schizophrenia Clinical Trial
Official title:
A Randomized Double-Blind, Placebo-Controlled, Proof of Concept Study of Intravenous Sodium Nitroprusside in Adults With Symptomatic Schizophrenia
The primary objective of this study is to investigate whether a single infusion of intravenous sodium nitroprusside (0.5 μg/kg/min for 4 hours) is superior to placebo (5% dextrose solution) at in treating positive and negative symptoms of schizophrenia
This is a phase II proof of concept (POC), multi-center, prospective, randomized,
placebo-controlled, Sequential Parallel Comparison Design (SPCD) study, in which a total of
60 subjects with schizophrenia will be enrolled.
The study will be conducted in two stages. The study treatment will be administered in a
double-blind fashion for all subjects throughout both stages of the study. A total of 60
subjects with schizophrenia will be randomized in a 1:1:1 ratio to drug-drug sequence [n=20;
i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at week 0 and week 2], placebo-drug
sequence [n=20; i.v. placebo at week 0 and i.v. sodium nitroprusside (0.5 μg/kg/min for 4
hours) at week 2], and placebo-placebo sequence [n=20; i.v. placebo at week 0 and again at
week 2]. The 4-week double-blind phase of treatment will be divided into two phases: Phase 1,
from week 0 to week 2, and Phase 2 from week 2 to week 4. At the end of Phase 1 (week 2), the
randomized subjects will be assessed and categorized into responders and non-responders,
based on 20% or more reduction from baseline in their PANSS total score as per the
evaluations at Randomization Visit (week 0). The data from the patients deemed placebo
non-responders in phase 1 who go on to either stay on placebo or to receive treatment with
sodium nitroprusside will be pooled with the data from Phase 1 from all subjects, according
to SPCD.
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