A Proof of Concept Study of Intravenous Sodium Nitroprusside in Adults With Symptomatic Schizophrenia

Description

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 

Study Start Date

May 2015

Estimated Completion Date

January 2017

Interventions

  • Drug: sodium nitroprusside
  • Other: Placebo

Specialties

  • Internal Medicine: Clinical Pharmacology,Psychiatry
  • Psychiatry : Neuro/Psych Pharmacol,Schizophrenia/Psychosis
  • Family Medicine: Clinical Pharmacology,Psychiatry
  • Pharmacy: Neuro/Psych pharmacology

MeSH Terms

  • Mental Disorders
  • Nitroprusside
  • Schizophrenia

Study ID

Massachusetts General Hospital -- 2014P001204

Status

Unknown

Trial ID

NCT02164981

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

60

Sponsor

Massachusetts General Hospital

Inclusion Criteria

    Each subject must meet all of the following criteria to be eligible for this study: 1. Males or Females aged 18-55 years inclusive. 2. Primary diagnosis of Schizophrenia established by a structured psychiatric evaluation (SCID) based on Diagnostic and Statistical Manual of Mental Disorders Forth Edition (DSM-IV-TR) criteria. 3. Written informed consent in compliance with 21 CFR part 50 and in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. 4. A Positive and Negative Syndrome Scale (PANSS) (Kay et al., 1994) total score 70 with a score of > 4 on two or more of the following PANSS items: delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content. 5. A score of ?4 on the Clinical Global Impression—Severity (CGI-S) (Guy, 1976). 6. Confirmation of both diagnosis and severity of psychosis symptoms by an independent MGH SAFER interview. 7. Must have ongoing antipsychotic treatment for at least 8 weeks, with a stable dose for at least 4 weeks. Subjects refractory to antipsychotic treatment, defined as failure to achieve clinically-recognized symptom reduction) to ? 2 marketed antipsychotic agents, given at a Physician Desk Reference (PDR)-defined therapeutic dose for ? 8weeks over the prior 12 months, as assessed by the MGH FAST will be eligible. 8. Understands and is able, willing, and (in the opinion of the investigator) likely to fully comply with the study procedures and restrictions.

Exclusion Criteria

    Subjects who meet any of the following criteria will be excluded from the study. 1. Subjects with a history of renal insufficiency, congestive heart failure, cardiac arrhythmias or history of myocardial infarction. 2. Subjects with a history of symptomatic orthostatic hypotension defined as sitting to standing systolic blood pressure < 90mmHg or diastolic blood pressure < 60mm Hg with any of the following symptoms: lightheaded or dizzy upon standing, blurry vision,weakness,fainting (syncope),confusion, or nausea. 3. Subjects with any clinically significant abnormalities as determined by medical history, physical exam, clinical and lab evaluation suggestive of an underlying disease state that may, in the opinion of the investigator, may confound the results of study, increase risk to the subject or lead to difficulty complying with the protocol. 4. Subjects on clorpromazine, PDE-5 inhibitors, nitrites and any medication with CNS effects excluding, patients on antipsychotic drugs, anticholinergics, b-adrenergic antagonists, amantadine, biperiden, diphenhydramine, lorazepam, zolpidem, and temazepam . 5. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed at baseline visit prior to randomization. Women enrolled in this trial must use adequate birth control. 6. Subjects with a current (within the last 3 months) DSM-IV-TR diagnosis of alcohol or substance use disorder or dependence (excluding nicotine) as established by the clinical assessment (SCID) at the screening visit will be excluded. 7. Subjects at imminent risk of suicide or injury to self or others, as per the opinion of the investigator, or history of significant suicide attempt within the last 6 months as per C-SSRS. 8. Subjects that have taken an investigational drug or taken part in a clinical trial within 30 days prior to screening. 9. Any other reason that, in the opinion of the investigator, would compromise patient safety or integrity of the study

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (4)

Study Location Distance Name Phone Email
Zucker Hillside Hospital - Glen Oaks, New York 40.7 miles Jennifer Alexander BA 718-470-8442 jalexande5@NSHS.edu
New York University Langone Medical CenterBellevue Hospital - New York, New York 50.2 miles Helen Tan BA 646-754-4810 Helen.Tan@nyumc.org
University of Massachusetts Medical School - Worcester, Massachusetts 105.6 miles Domenico Lombardi BA 508-856-2505 Domenico.Lombardi@umassmed.edu
Schizophrenia Clinical Research Program Massachusetts General Hospital - Boston, Massachusetts 137.9 miles Chris McCain BA 617-912-7864 CMCCAIN@mgh.harvard.edu

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