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OpenTrials
Completed

NCT Number: NCT01223729

Acetyl-L-Carnitine Reduces Depression and Improves Quality of Life in Patients With Minimal Hepatic Encephalopathy

Minimal hepatic encephalopathy represents a common complication present in well-compensated cirrhotic patients that impairs patients daily functioning and health-related quality of life. Acetyl-L-carnitine has been shown to be useful in improving blood ammonia and cognitive functions in cirrhotic patients with minimal hepatic encephalopathy. This study evaluated the effects of acetyl-L-carnitine treatment on health related quality of life and on depression in patients with minimal hepatic encephalopathy.

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Key information

Age range

34 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cannizzaro Hospital

Catania, 95126, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients diagnosed as having cirrhosis at the outpatient Internal Medicine of the Department of Senescence of Cannizzaro Hospital (Catania) were candidates for enrolment. The diagnosis of cirrhosis was based on clinical, biochemical and ultrasonographic or liver histological data.

Exclusion criteria

  • Exclusion criteria were overt hepatic encephalopathy or a history of overt HE; history of recent alcohol intake; infection; recent antibiotic use or gastrointestinal bleeding; history of recent use of drugs affecting psychometric performances like benzodiazepines, antiepileptics or psychotropic drugs; a history of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension; electrolyte imbalance; renal impairment; hepatocellular carcinoma; severe medical problems such as congestive heart failure, pulmonary disease or neurological or psychiatric disorder that could influence quality of life measurement; inability to perform neuropsycological tests.

Treatment and study plan

Acetyl-L-carnitine

Drug

2 g acetyl-L carnitine twice a day

Placebo

Other

placebo twice per day

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Important dates

Study start
2002
Study completion
2005
First posted
Oct 19, 2010
Registry last updated
Oct 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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