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 |
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.
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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