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Unread 03-15-2010, 10:35 AM   #1
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Default Article: SSRI, Naltrexone, Talk Therapy Keep Depressed Alcoholics Dry

SSRI, Naltrexone, Talk Therapy Keep Depressed Alcoholics Dry

By John Gever, Senior Editor, MedPage Today
Published: March 15, 2010
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.

Action Points
Explain to interested patients that alcohol abuse and depression often go together, and their co-occurrence makes both conditions more difficult to treat.

Combining sertraline (Zoloft) and the opioid antagonist naltrexone better than either drug alone or placebo in keeping depressed alcoholics sober, researchers said.

When added to cognitive behavioral therapy, 53.7% of alcoholic and depressed patients taking the two drugs achieved abstinence for a median of 98 days, compared with rates of 21.3% to 27.5% and median durations of less than a month for either drug alone or placebo (P=0.001), reported Helen M. Pettinati, PhD, of the University of Pennsylvania in Philadelphia, and colleagues.

Writing online in the American Journal of Psychiatry, the researchers indicated that depression and alcohol dependence frequently occur together and is particularly difficult to treat.

"The present findings suggest that patients with both disorders would benefit from combination treatment with an antidepressant and medication for alcohol dependence," they wrote.

The study enrolled 170 patients with both depression, defined as a Hamilton Depression Rating Scale score of at least 10, and alcohol dependence meeting DSM-IV criteria.

Patients were excluded if they had other substance dependence issues except for tobacco, or if they had other mental illnesses other than depression.

As a result of these exclusions, only about half of patients screened were accepted into the study.

All patients received weekly sessions of cognitive behavioral therapy. They were randomized to receive one of the following treatment regimens for 14 weeks: double placebo, sertraline at 200 mg/day plus placebo, naltrexone at 100 mg/day plus placebo, or both drugs at those doses.

The main outcome measures for alcohol dependence were the percentage of patients totally abstinent during treatment and the median and mean time to resume heavy drinking.

Oddly, the mean duration of abstinence in the combined-drug patients was much shorter than the median -- 64 days (SD 40.8) versus 98 days.

For the other treatment groups, the means were ranged from 40 to 45 days, almost double the medians.

The combination regimen was also more effective than the other treatments against depression.

The mean Hamilton score after treatment was 6.9, with 83.3% of patients no longer clinically depressed.

In the other treatment arms, mean Hamilton scores were higher (8.0 to 11.7, P=0.04 relative to the combination) and fewer patients achieved clinical remission (48.1% to 68.8%).

Sertraline monotherapy actually was the least effective among the four treatments in relieving symptoms of depression, although the difference from double placebo and naltrexone monotherapy was not large.

As with most treatments for alcoholism, treatment failures were common. From 41% to 48% of each group failed to complete the 14-week regimen.

Adverse events were the most common reason in the combination-drug group (seven of 18 dropouts), whereas clinical deterioration was most common with double placebo and drug monotherapy.

Nevertheless, after 90 days, about 43% of patients in the combination group were abstinent, compared with 12% to 21% of patients in the other groups.

About 54% of combination-group patients did not have a heavy drinking day within the first 90 days after starting treatment, compared with about 30% in each of the other groups.

Adverse events were common and many were rated as severe or very severe, including anxiety and irritability (29% of patients), fatigue (25%), sexual dysfunction (29%), and headache (14%).

Ashwin Patkar, MD, of Duke University in Durham, N.C., who was not involved with the study, told MedPage Today that the study had a "good take-home message for physicians in terms of how they can use medications and combine them with behavioral therapy for alcohol dependence."

But Patkar, who has contributed a commentary on the study to be published in the journal when it appears in print, also cautioned that clinicians in ordinary practice may not experience the same level of results reported in the study. The researchers excluded many patients with common comorbidities that might reduce the effectiveness of treatment, he noted.

He also pointed to the relatively high adherence to treatment in the study -- 87% for medications across the entire sample, and 59% for the weekly therapy sessions -- indicating it was both a strength and a limitation of the study.

Patkar said treatment compliance in ordinary practice is not usually that good. It's typically higher in clinical trials because of the supervision and encouragement that participants receive. But he added that it's not impossible for clinicians to fill that role or enlist others to help.

"They can encourage that kind of supervision and adherence in their patients and get good outcomes," he said.

In treating his own patients, Patkar said, "I make sure there is a member of the family who is involved with the care, and who actually becomes almost a part of the treatment team -- supervising medications, supervising visits, and reporting to us what is going on."

The study was supported by the National Institute on Alcohol Abuse and Alcoholism and Pfizer, which supplied sertraline and matching placebo.

Study authors reported relationships with Alkermes, Eli Lilly, Merck, GlaxoSmithKline, Lundbeck, Abbott, and Ernbera Neurotherapeutics.

Patkar has had relationships with AstraZeneca, Bristol-Myers Squibb, Forest, GlaxoSmithKline, Janssen, McNeil Consumer and Specialty, Organon, Orphan Medical, Titan, Pfizer, Reckitt Benckiser, Cephalon, Jazz, and Lundbeck.

Primary source: American Journal of Psychiatry
Source reference:
Pettinati H, et al "A Double-Blind, Placebo-Controlled Trial Combining Sertraline and Naltrexone for Treating Co-Occurring Depression and Alcohol Dependence" Am J Psychiatry 2010; DOI: 10.1176/appi.ajp.2009.08060852.
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