Healthy Skepticism Library item: 6344

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Publication type: news

Goetinck Ambrose, S
Depression study: Fewer steps better
Dallas Morning News 2006 Nov 1
http://www.dallasnews.com/sharedcontent/dws/dn/latestnews/stories/110106dnmetdepression.3453403.html

Full text:

Depression study: Fewer steps better

Odds of remission drop with repeated attempts at treatment, trial finds

12:01 AM CST on Wednesday, November 1, 2006

By SUE GOETINCK AMBROSE / The Dallas Morning News

The nation’s largest study on the treatment of depression suggests that a patient’s persistence in getting help – by trying various drugs and other strategies – can pay off. But the study also found that the odds of beating the disease diminished after each unsuccessful attempt at recovery.

In the study, which was coordinated by UT Southwestern Medical Center at Dallas, patients who had to undergo more treatments to get better were more likely to fall back into depression. So were patients whose symptoms improved but who didn’t achieve full remission. And some patients never got better.

“If it takes more steps to get [better], you really have to be careful, because in the long run, you have more of a chance to relapse,” said Dr. A. John Rush, the UT Southwestern psychiatrist who led the study.

The message to patients is “follow up with the doctor, monitor your symptoms, and make adjustments to doses or types of drugs,” he said.

These findings, reported Wednesday in the American Journal of Psychiatry, are the latest from the six-year, $35 million STAR*D trial, the largest study to measure how well depression treatment works on everyday patients in private practice and public clinics, outside the structure of clinical trials.

In contrast to many previous clinical trials that carefully select patients with few or no other health complications, the STAR*D study took virtually all comers. For example, some participants had substance abuse problems or other psychiatric disorders.

The study involved more than 3,600 adult patients and was conducted at 41 primary-care and psychiatric clinics around the country. Most patients in the trial received only medication, while 147 patients received therapy, too. Patients were initially all assigned the antidepressant Celexa. Those who didn’t go into remission or who couldn’t tolerate the drug were encouraged to proceed to the study’s next level, where they could receive an additional or different medication, or therapy.

Patients who didn’t experience remission after the second level could go on to a third level of medication, and if needed, a fourth level.

The researchers found that the remission rates were about 37 percent for the first level, 31 percent for the second level and 13 percent for both the third and fourth levels. Some patients dropped out of the study without reporting whether they went into remission, so it wasn’t possible to calculate an overall remission rate with certainty.

Based on those numbers, the overall remission rate could be as high as 67 percent, but in actuality, it was probably lower, Dr. Rush said.

Another way to look at the data is to calculate how many people recover without relapsing, said Dr. Craig Nelson, a psychiatrist who wrote an editorial on the study in the same journal. “The first step is getting the person well,” said Dr. Nelson of the University of California, San Francisco. “The second step is keeping them well.”

The sustained recovery rate came in much lower, at about 43 percent, according to Dr. Nelson. For technical reasons, that number is also only a ballpark figure.

Meanwhile, patients’ intolerance to the treatment increased as they had to go through each level of treatment. In the study, intolerance was defined as dropping out for any reason during the first four weeks of a level, or because of side effects after that.

At the first level of treatment, the intolerance rate was about 16 percent. By the fourth level it had reached 34 percent. Dr. Rush said that the rising rates might have been because the medication protocols grew more complex with each level.

Unanswered questions
The findings leave several questions unanswered, Dr. Rush said. The study couldn’t distinguish whether patients got better simply because of the passage of time or because of the medication, the researchers noted.

The researchers also don’t know why some people never responded to treatment. They may have a biologically different form of depression, or medical problems might have prevented the treatments from working as well, Dr. Rush said. In that case, treatments other than medication or therapy might have helped, the researchers wrote.

The STAR*D study was funded by the federal government’s National Institute of Mental Health. The article also lists that almost all the scientists on the study, including Dr. Rush and two other UT Southwestern researchers, have financial ties to pharmaceutical or medical care companies.

Financial connections between medical care companies and university researchers are becoming more common and can be problematic, said Dr. Jerome Kassirer, professor of medicine at Tufts University and former editor-in-chief of the New England Journal of Medicine.

However, the current study benefits from its good design, said Dr. Kassirer, author of On the Take: How Medicine’s Complicity With Big Business Can Endanger Your Health. Dr. Rush said that the study was heavily peer-reviewed, and no pharmaceutical company saw the journal article before publication. Also, all the data and methods were published in the report.

Focus on meds
Dr. Kassirer did note that the study focused heavily on treatment via medication, with little mention of cognitive therapy. Dr. Rush said that other studies have shown that cognitive therapy can also be an effective treatment for depression, and that the STAR*D data on therapy would be explored in a forthcoming article.

Dr. Thomas Insel, director of the NIMH, said that many patients who were offered therapy didn’t want it, saying they didn’t have the time to meet with a therapist each week.

He also noted that the study had many safeguards to ensure data was reported carefully and thoroughly. It’s virtually impossible to avoid running a study using researchers who have received money from pharmaceutical companies, he said. That’s because until recently, the government hadn’t funded clinical trials on depression, but the companies had.

In the United States, depression affects about 15 million adults each year – more women than men. Children can also be affected, but the current study did not address depression treatment in children.

E-mail sgoetinck@dallasnews.com