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

Minimal Hepatic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223729
• Other study ID #: 8-12-00 A
• Status: Completed
• Phase: N/A
• First received: October 18, 2010
• Last updated: October 18, 2010
• Start date: April 2002
• Est. completion date: November 2005

Study information

• Verified date: December 2000
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: University of Catania
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 2005
• Gender: Both
• Age group: 34 Years to 67 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy
• Minimal Hepatic Encephalopathy

Intervention

Drug:
• Acetyl-L-Carnitine
2 g acetyl-L carnitine twice a day

Other:
• placebo
placebo twice per day

Locations

Country	Name	City	State
Italy	Cannizzaro Hospital	Catania

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Malaguarnera M, Gargante MP, Cristaldi E, Vacante M, Risino C, Cammalleri L, Pennisi G, Rampello L. Acetyl-L-carnitine treatment in minimal hepatic encephalopathy. Dig Dis Sci. 2008 Nov;53(11):3018-25. doi: 10.1007/s10620-008-0238-6. Epub 2008 Mar 21. — View Citation