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Severe Alcohol Addiction May Be Widely Prevalent In Bipolar Patients: Presented at APA

SAN FRANCISCO, CA -- May 20, 2003 -- Findings from a new study presented at the American Psychiatric Association's 156^th Annual Meeting examine the prevalence of severe alcohol dependence in bipolar disorder patients.

Preliminary data suggest that bipolar patients with alcohol dependence may suffer from substantial psychiatric comorbidity as well as alcohol addiction. The mean Michigan Alcoholism Screening Test (MAST) score of participants in the study was 16 (a score more than five indicates alcohol dependence). Furthermore, in a 30-day time-line follow-back (TLFB) account (which measures the amount of alcohol and number of drinking days), the average bipolar patient with alcohol dependence consumed approximately 152 drinks per month (11 drinks per day, 14 days per month).

"Past studies were generally ineffective in determining the extensiveness of alcoholism in bipolar patients and failed to study patients with a history of co-morbid alcohol abuse," said Mark Frye, M.D., assistant professor of psychiatry at UCLA's David Geffen School of Medicine and director of the UCLA Bipolar Disorder Research Program. "In the current study we are evaluating, our preliminary results show there is a great need for further formal study to evaluate treatment responses to mood stabilizers."

Study Methodology and Results
This single-blind study was designed to assess the extent of psychiatric co-morbidity and alcohol use in bipolar outpatients currently participating in a study evaluating divalproex versus olanzapine for alcohol abuse relapse prevention. The year-long, ongoing study will involve 60 patients between the ages of 18 and 65. To date, 21 participants have completed an Institutional Review Board (IRB) approved consent, with 20 patients being included in the current analyses.

Advertisements were placed in local newspapers and outpatient clinics in the greater Los Angeles district to recruit patients. Patients were diagnosed with bipolar disorder and current alcohol abuse/dependence using SCID-IV (Structured Clinical Interview for DSM-IV). Based on a rigorous set of inclusion criteria, one-third of respondents (60 participants) were selected. Psychometrics completed at initial evaluation included a structured interview for DSM-IV, MAST, a Severity of Alcohol Dependence Questionnaire (SADQ), a 30-day Time Line Follow-Back (TLFB) of alcohol consumed over last 30 days, and the Addiction Severity Index (ASI).

Preliminary results show the average participant consumed an average 151.6 drinks per month (10.8 drinks per day, 14.3 days out of the month). The mean MAST score was 16. Data also suggests that bipolar patients with current alcohol dependence have other substantial psychiatric disorders, particularly post-traumatic stress disorder and social anxiety. In addition, findings show none of the participants was receiving treatment or medication for bipolar disorder.

About Bipolar Disorder
Bipolar disorder (also known as manic-depressive illness) is a biochemically-based mood disorder that affects more than 2.3 million people in the United States. Symptoms and severity vary, but the disorder is marked by mood changes that cycle over time from periods of elevated mood (mania), to periods of depressed mood, to times when mood is normal. Often beginning in adolescence or early childhood, bipolar disorder can be dangerous if left untreated or undiagnosed.

According to recent statistics, as many as 20 percent of people living with untreated bipolar disorder take their own lives. In addition, patients have high rates of substance abuse and participate in behaviors risky to themselves and others. However, the symptoms of bipolar disorder are highly treatable and manageable. Medication is an essential part of successful treatment.

Important Safety Information
Divalproex sodium delayed release tablets are indicated for the treatment of acute mania associated with bipolar disorder. Divalproex sodium is also indicated for the prevention of migraine headaches in adults and for the treatment of complex partial seizures and simple and complex absence seizures in adults and children. Divalproex sodium products should not be administered to patients with hepatic disease or significant hepatic dysfunction. Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid and its derivatives, usually during the first six months of treatment. Divalproex sodium may produce teratogenic effects in the offspring of women receiving the drug during pregnancy. Benefits of using divalproex sodium should be weighed against risk of injury to the fetus in women of childbearing potential. Cases of life-threatening pancreatitis, some rapidly progressing to death, have been reported in both adults and children receiving divalproex sodium. Divalproex sodium is contraindicated in patients with known urea cycle disorders (UCD), a group of uncommon genetic abnormalities, due to reports of sometimes-fatal cases of hyperammonemic encephalopathy. The frequency of adverse effects, particularly elevated liver enzymes and thrombocytopenia, may be dose-related. Some elderly dementia patients taking valproate in a clinical trial experienced somnolence, sometimes requiring discontinuation. Safety and effectiveness of divalproex sodium in the prevention of migraine in patients over 65 has not been established.

More information, including full prescribing information is available at www.depakote.com, or by calling Abbott Medical Information at 1-800-633-9110.


SOURCE: Fleishman Hillard Inc.

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