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

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ClinicalTrials.gov Identifier: NCT01223729
Recruitment Status : Completed
First Posted : October 19, 2010
Last Update Posted : October 19, 2010
Sponsor:
Information provided by:
University of Catania

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Minimal Hepatic Encephalopathy Drug: Acetyl-L-Carnitine Other: placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Acetyl-L-Carnitine Reduces Depression and Improves Quality of Life in Patients With Minimal Hepatic Encephalopathy
Study Start Date : April 2002
Study Completion Date : November 2005

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Acetyl-L-Carnitine Drug: Acetyl-L-Carnitine
2 g acetyl-L carnitine twice a day
Placebo Comparator: placebo Other: placebo
placebo twice per day


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   34 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223729


Locations
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Italy
Cannizzaro Hospital
Catania, Italy, 95126
Sponsors and Collaborators
University of Catania
More Information
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Publications:

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Responsible Party: Mariano Malaguarnera, University of Catania
ClinicalTrials.gov Identifier: NCT01223729    
Other Study ID Numbers: 8-12-00 A
First Posted: October 19, 2010    Key Record Dates
Last Update Posted: October 19, 2010
Last Verified: December 2000
Keywords provided by University of Catania:
Acetyl-L-carnitine;
Minimal hepatic encephalopathy;
Quality of life;
Depression.
Additional relevant MeSH terms:
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Hepatic Encephalopathy
Brain Diseases
Depression
Behavioral Symptoms
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
 Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Acetylcarnitine
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Nootropic Agents