Treatment of Hepatic Encephalopathy With Flumazenil and Change in Cortical GABA Levels in MRS

Withdrawn before enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Hepatic Encephalopathy, Liver Cirrhosis

In brief

The purpose of this study is to test feasibility of measuring flumazenil-induced changes in cortical GABA levels observed with localized 1H-MRS in relation to changes in severity of hepatic encephalopathy (HE) in subjects with non-alcoholic liver cirrhosis. This study is a double-blind, placebo-controlled, randomized, cross-over design.

Key facts

Study ID

NCT02048969

Run by

Yale University

People needed

0

Starts

2014-06-01

Expected to finish

2017-10-01

Last updated by the study team

2020-07-07

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 18 and older
• ICD-9 diagnosis of hepatic encephalopathy
• Ability to feel comfortable in confined areas (like MRI)
• Ability to provide informed consent
• Speaks fluent English without any communication barriers
• Reliable family member or friend able to stay with participant during abstinence from HE medication prior to visit.

You may not qualify if…

• Current DSM-IV-R diagnosis of Alcohol or Other Drug Abuse or Dependence
• Positive screen for alcohol abuse as determined by the CAGE questionnaire
• Positive urine toxicity screen for benzodiazepine medications or illicit drugs
• History of long-term use of benzodiazepine medications
• Current use of non-benzodiazepine agonist medications
• History of Panic Disorder
• History of any Psychotic Disorder
• History of seizures and/or Seizure Disorder
• History of dysrhythmia, cardiovascular collapse, or recent head trauma
• History of side effects from anticholinergic medications
• History of cyclic antidepressant overdose or poisoning
• Pregnant or nursing
• Resides in nursing home or other long-term care facility

Where it is running

• Yale Psychological Medicine Research Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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