Study led by Brown professor showed that patients receiving sertraline were 4.1 times less likely to suffer depression recurrence than those taking a placebo
A national team of researchers led by Dr. Martin B. Keller has published the first study that suggests an effective drug treatment for chronically depressed patients. The researchers say that the drug sertraline, prescribed under the brand name Zoloft, can safely stop depression from recurring even in the most chronic sufferers.
For these individuals, the researchers report that sertraline protects against recurrence and greatly extends remission time. Sertraline is not currently indicated for use in the treatment of chronic depression. Previous research has shown it to be effective in preventing relapse in patients suffering non-chronic episodes of major depression.
The World Health Organization identifies depression as one of the world's four most disabling illnesses. Depression also has enormous economic costs because a patient's capacity to work or be an effective parent often is diminished. About 3 percent of the population is chronically depressed.
Although the psychiatric community widely accepts the value of maintaining treatment for chronically depressed patients, there had been no adequately designed medical studies that examined the efficacy of maintenance therapy.
The research done by Keller and his colleagues has greatly expanded the empirical base of research on maintenance therapy for the chronically depressed. Their findings are described in the current Journal of the American Medical Association (JAMA). The results are the first from any study to suggest an effective drug treatment for patients with the most severe and disabling forms of chronic depression.
"The bottom line is that chronic types of depression are disabling and vastly undertreated," Keller said. "The study describes an effective way to deal with chronicities if identified and consistently treated." Keller is professor and chairman of the Department of Psychiatry and Human Behavior at the School of Medicine.
The researchers conducted a 19-month study that involved 161 chronically depressed patients treated at 12 outpatient psychiatric clinics nationwide. Many patients had suffered chronic major depression - a severe form of at least two years duration - for more than 20 years. Other patients suffered double depression - an acute form of major depression - combined with dysthymia, a chronic, milder depression present for at least two years.
Before entering the study, patients had responded positively to sertraline in a 12-week trial and had continued to respond well in a four-month extended treatment. In the study, 77 patients maintained sertraline use for 76 more weeks, while 84 patients took a placebo daily.
The study, sponsored by Pfizer, Inc., manufacturer of Zoloft, showed that patients receiving sertraline were 4.1 times less likely to suffer depression recurrence than those taking a placebo. The researchers called sertraline "very well tolerated" over many months at an average daily dose of about 146 mg. Indeed, just one side effect was found to be statistically significant. Thirteen sertraline patients complained of sexual dysfunction compared to two individuals on placebo, a side effect commonly seen with antidepressant treatments.
The JAMA findings complement those in three new articles reporting on the initial 12 weeks of chronic-depression treatment. Keller is the lead or co-author of all three articles. To be published in the November issue of the Journal of Clinical Psychiatry, the articles describe rapid improvement in the psychological and social behaviors among 635 depressed patients treated with either sertraline or the drug imipramine. From increased productivity at work to better social relationships, patients showed great improvements, he said.
The new body of research does not suggest that depressed patients be treated only with drugs. The most effective treatments may combine medication and psychotherapy, Keller said. He is leading a large-scale study of medication alone, psychotherapy alone, and the combination of both in patients with chronic depression.
Zoloft is one of four medications in use, including Prozac, Paxil and Celexa, that belong to the class of drugs called selective seretonin re-uptake inhibitors. The drugs block re-uptake of the chemical seretonin in the synapses between neurons in the nervous system. This action is thought to alleviate the symptoms and syndromes of depression, and keeps them from returning.