'Adequate' Treatment Isn't Enough to Make Most Depressed Patients Become Symptom Free Study calls for early and aggressive monitoring of patient response to antidepressants INDIANAPOLIS, June 14 /PRNewswire-FirstCall/ -- Despite following their primary care doctor's orders, only 23 percent of depressed patients taking therapeutically adequate doses of three common antidepressants in a large study became symptom free, suggesting physicians need more help recognizing depression, evaluating patient response to treatment and following published guidelines, according to a paper published in the June 14 issue of the Archives of Internal Medicine. The ARTIST (A Randomized Trial Investigating SSRI Treatment) study compared the effectiveness of three serotonin reuptake inhibitors (SSRIs) in patients being treated by primary care physicians in a real-world setting. Although 64 percent of patients completing the trial received "adequate" treatment, three out of four still reported significant symptoms of depression, such as depressed mood, loss of interest in things or low energy. Patients were deemed adequately treated if they continued on medication at therapeutic levels for six months, the time required to meet minimum practice guidelines. According to current treatment guidelines, most of these patients needed a more aggressive treatment approach, such as an increase in dose or a switch in therapy, than they received. Even with more rigorous treatment strategies than are generally reported in primary care studies, there continues to be less-than-optimal remission and partial-response rates, according to the study. "To give patients their best chance at getting completely well, all of their symptoms need to be addressed, emotional and physical," said Ralph Swindle, Ph.D., Research Clinical Psychologist at Eli Lilly and Company. "Depression can make every day seem like a nightmare. For that reason, physicians should monitor patient progress early and often, preferably with brief outcome measures. The findings suggest they need to make adjustments in treatment when a patient fails to improve or only partially responds to initial treatment." According to practice guidelines,(1) if a patient does not feel better after two months of treatment, their physician should increase the dose, switch medications or augment with a second medication or psychotherapy to help patients achieve success. Complete resolution of all depression symptoms is the goal of treatment. When symptoms don't go away completely, patients can have difficulty getting well and staying that way.(2) "Patients need to know they should expect more from depression treatment. They need to be encouraged to continue treatment until all depression symptoms (physical and emotional) are gone," Swindle said. "Patients and their loved ones need to be encouraged to be an active and vocal participant in treatment. If their treatment isn't making a difference after two months, it is time for a discussion with your physician that the treatment needs to change." Additional Study Highlights * Among all patients, 46 percent were classified as non-responders after six months, and 32 percent were classified as partial responders. * Among all patients, 53 percent received therapy classified a priori as "adequate," but did not achieve remission by six months. * Thirteen percent of patients in this naturalistic study received therapy defined as "aggressive" therapy. This was defined as being on medication for each evaluation period in the study; having at least one medication switch and one medication increase, or more than one switch in therapy; or having later-stage therapies for at least one evaluation. These treatment patterns are consistent with recommended treatments for more treatment-resistant depressions. Patients who achieved remission at six months continued to have the best average scores on each of the depression and psychological measures at nine months. * Conducting such a study in a "real world setting" provides an evaluation of effectiveness of therapy in clinical practice. Scientifically, however, the findings of such studies may be less reliable because of the lack of rigorous controls found in randomized clinical trials. Methods Participants in the nine-month study were males and females, 18 years of age and older, who were screened for depression by their primary care physician and deemed appropriate for SSRI therapy. A total of 573 patients were followed through structured telephone interviews conducted at baseline, one, three, six and nine months post enrollment. Patients were randomized to receive fluoxetine (20mg/day), paroxetine (20mg/day) or sertraline (50mg/day). After the initial randomization, the study was entirely naturalistic and observational, with treatment changes determined by the decisions of physicians and patients. Remission was defined as an SCL-20 score of 6 or less, with a minimum required change of 12.3 to be considered clinically meaningful. Partial response was defined as not meeting remission criteria but experiencing a 50 percent decrease in the Symptom Checklist-20 items (SCL-20) from baseline. Patients who were either off medication or were intermittently on medication after six months were considered inadequately treated. The primary outcome measure was the SCL-20. Secondary outcome measures included the Short Form 36 and subscales, the mental and physical component summary scores and subscales, a positive well-being scale from the RAND Medical Outcomes Study, self-reported disability days, and the number of symptoms reported on the Primary Care Evaluation of Mental Disorders (PRIME- MD) Depression Scale. Limitations The study was a naturalistic, open-label study designed to compare outcomes associated with SSRI therapy in usual primary care practices. Overall outcomes might have improved if there were designated strategies for dealing with less-than-adequate clinical response. Also, the outcomes evaluations were obtained independent of clinical care, and were not shared with physicians. If physicians had received those evaluations, they might have made different treatment decisions. Lastly, data on medication status comes from the patient, which can be inaccurate. The self-report mechanism was very thorough, however, in eliciting information about continuation, dose of medication, number of times per day medication was taken, and changes in medication. In addition, medication information was collected by telephone interview, by a trained interviewer not connected with the treating physician, to minimize the risk that patients would report "socially acceptable" adherence to treatment. About Lilly Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at http://www.lilly.com/ . (1) Practice Guideline for the Treatment of Patients With Major Depression, 2nd edition. (April, 2000): http://www.psych.org/psych_pract/treatg/pg/Depression2e.book-7.cfm - figure3 (2) Paykel ES, et al. Psychol Med. 1995;25(6):1171-1180. (Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO ) http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE: Eli Lilly and Company CONTACT: David Shaffer (US), +1-317-651-3710, cell: +1-317-997-0632, or Jennifer Yoder (OUS), +1-317-433-3445, cell: +1-317-652-0912, both of Eli Lilly and Company

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