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

U

University of Catania

Status

Completed

Conditions

Minimal Hepatic Encephalopathy

Treatments

Other: placebo
Drug: Acetyl-L-Carnitine

Study type

Interventional

Funder types

Other

Identifiers

NCT01223729
8-12-00 A

Details and patient eligibility

About

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.

Sex

All

Ages

34 to 67 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

67 participants in 2 patient groups, including a placebo group

Acetyl-L-Carnitine
Experimental group
Treatment:
Drug: Acetyl-L-Carnitine
placebo
Placebo Comparator group
Treatment:
Other: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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