Intravenous Sodium Nitroprusside in Adults With Symptomatic Schizophrenia



Status:Recruiting
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:3/12/2016
Start Date:August 2015
End Date:January 2017
Contact:Donald Goff, MD
Email:Donald.Goff@nyumc.org
Phone:646-754-4843

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A Randomized Double-Blind, Placebo-Controlled, Proof of Concept Study of Intravenous Sodium Nitroprusside in Adults With Symptomatic Schizophrenia

This is a Phase II or Proof of Concept (POC), randomized, double-blind, placebo-controlled,
multi-center study using a Sequential Parallel Comparison Design (SPCD) to demonstrate the
efficacy and safety of sodium nitroprusside (0.5 μg/kg/min for 4 hours) in treating the
positive and negative symptoms of subjects with schizophrenia.


Inclusion Criteria:

- Male or female

- Ages 18-60

- Schizophrenia, any subtype

- Treated with any antipsychotic for at least 8 weeks, with a stable dose for at least
4 weeks

- Sufficient proficiency in English to complete assessments

Exclusion Criteria:

- Any history of renal insufficiency, heart failure, cardiac arrhythmia, or myocardial
infarction

- Low blood pressure with any of the following symptoms: lightheaded or dizzy upon
standing up, blurry vision, weakness, fainting, confusion, or nausea

- Treated with clorpromazine, nitrites, PDE-5 inhibitors

- Major depression by DSM-IV criteria

- Suicide attempt or injury to self or others within the past year

- Active alcohol or other substance abuse or dependence within three months

- Positive drug screens

- Unstable medical illness

- Pregnant or nursing
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