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Ed. Note: The following is a press
release from the National Institute Of Mental Health.
March 22, 2006 --
Results of the
nation’s largest depression study show that one in three depressed patients
who previously did not achieve remission using an antidepressant became
symptom-free with the help of an additional medication and one in four
achieved remission after switching to a different antidepressant. The study,
funded by the National Institutes of Health’s National Institute of Mental
Health (NIMH), shows that people whose depression is resistant to initial
treatment can achieve remission — the virtual absence of symptoms — when
treated with a second strategy that either augments or switches medications.
This is the first study to examine the effectiveness of different treatment
strategies for those who did not become symptom-free after initial
medication.
John Rush, M.D.,
and Madhukar H. Trivedi, M.D., of the University of Texas Southwestern
Medical Center (UTSWMC), and colleagues report on the first major results of
the clinical trial, known as the STAR*D (Sequenced Treatment Alternatives to
Relieve Depression) study, in two papers published in the March 23, 2006
issue of the New England Journal of Medicine.
“These findings
provide important treatment options to mental health clinicians and the
millions of Americans who struggle with treatment-resistant depression,”
said NIH Director Elias A. Zerhouni, M.D.
Patients who did
not experience a remission of symptoms during the first level of the Star*D
study — in which they initially took the antidepressant citalopram, a
selective serotonin reuptake inhibitor (SSRI), for up to 14 weeks — were
eligible to enter level 2 of the trial where they were offered additional
treatment options designed to help them become symptom-free.
“If the first
treatment attempt fails, patients should not give up,” said NIMH’s director
Thomas Insel, M.D. “By remaining in treatment, and working closely with
clinicians to tailor the most appropriate next steps, many patients may find
the best single or combination treatment that will enable them to become
symptom-free.”
The 1,439
patients who were eligible and volunteered to enter level 2 were presented
with seven different treatment options. Only very few participants said that
all of the choices were equally acceptable and allowed themselves to be
randomly assigned to any one of them. All the rest of the participants
identified at least one of the treatments as being unacceptable, and chose
to limit the treatments to which they would allow themselves to be randomly
assigned. Fifty-one percent (727) of the patients chose options that
included switching to a different medication and were randomly assigned to
one of the three switch medications. Thirty-nine percent (565) chose options
that included augmenting the citalopram they were already taking, and were
randomly assigned to one of the two augmenting medications.
The 727 patients
who received the switch medication treatments were randomized to take one of
three medications currently available and used in practice — sertraline (an
SSRI that targets the neurotransmitter serotonin), bupropion-SR (a non-SSRI
antidepressant), or venlafaxine-XR (an agent that targets serotonin and
norepinephrine, another neurotransmitter).
Rush and
colleagues found that 25 percent of the patients who switched to a new
medication became symptom-free within 14 weeks; this was similar within each
of the three treatment groups. Additionally, no significant differences were
found in the efficacy, safety or tolerability of the three medications to
which patients were switched.
“Contrary to what
previous research suggests, this study shows that all three medications the
patients switched to, despite having different mechanisms of action, appear
to be useful options for treating depression following failure on the first
SSRI,” said Rush. “The results provide patients and doctors with important
information that intolerance or lack of efficacy with one SSRI seems not to
predict the same with another.”
The 565 patients
who received the augment medication were randomized to take either bupropion-SR
(a non-SSRI antidepressant) or buspirone (a medication that enhances the
action of an SSRI) in addition to the SSRI citalopram that they were already
taking in Level 1. Within 14 weeks of using either treatment, about one
third of the patients who enrolled in the augmentation study became
symptom-free, Trivedi and colleagues reported. Both combinations appeared
similar in terms of remission; however, those who augmented citalopram with
bupropion-SR experienced fewer symptoms, a greater degree of symptom relief
and lower side effects compared to those who augmented with buspirone.
“Augmenting the
first medication may be an effective way for people with depression to
become symptom-free,” said Trivedi. “Augmenting earlier in the course of
treatment, or perhaps prescribing a combination of drugs to patients
initially, may be more effective than using one treatment alone.”
According to the
researchers, the switch and augment treatments cannot be directly compared
because of the way the trial was designed. The results, however, can be used
to help guide treatment choices within each group; it also may be that
different people respond better to one as opposed to another treatment.
“Further research
may help customize the treatment to the individual patients,” says Rush.
Study participants who still did not achieve remission in level 2 had the
option of completing up to two additional levels of treatment. Results from
levels 3 and 4 of the STAR*D trial will be published later this year.
STAR*D is part of
an overall NIMH effort to conduct practical clinical trials in “real world”
settings that address public health issues important to those persons
affected by major mental illnesses.
Other study
authors include:
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Stephen
Wisniewski, Ph.D., University of Pittsburgh
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Andrew
Nierenberg, M.D., Massachusetts General Hospital
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Diane Warden,
Ph.D., University of Texas Southwestern Medical Center
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Louise Ritz,
M.B.A., NIMH
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Barry Lebowitz,
Ph.D., University of California, San Diego
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Kathy
Shores-Wilson, Ph.D., University of Texas Southwestern Medical Center
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Melanie Biggs,
Ph.D., University of Texas Southwestern Medical Center
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Maurizio Fava,
M.D., Massachusetts General Hospital
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Jonathan W.
Stewart, M.D., Columbia University
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Michael E.
Thase, M.D., University of Pittsburgh
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James F.
Luther, M.A., University of Pittsburgh
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George
Niederehe, Ph.D., NIMH
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Frederick
Quitkin, M.D., Columbia University
For more
information on STAR*D level 2, visit:
For more
information on STAR*D level 1, visit:
For general
information on the STAR*D study, visit:
NIMH is part
of the National Institutes of Health (NIH), the Federal Government's primary
agency for biomedical and behavioral research. NIH is a component of the
U.S. Department of Health and Human Services.
The National
Institutes of Health (NIH) — The Nation's Medical Research Agency —
includes 27 Institutes and Centers and is a component of the U.S. Department
of Health and Human Services. It is the primary federal agency for
conducting and supporting basic, clinical and translational medical
research, and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and its programs,
visit http://www.nih.gov.
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