'Adequate' Treatment Isn't Enough to Make Most Depressed Patients Become Symptom Free
15 June 2004 - 2:34AM
PR Newswire (US)
'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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