NEW STRATEGIES HELP DEPRESSED PATIENTS BECOME SYMPTOM-FREE

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U.S. Department of Health and Human Services 
NATIONAL INSTITUTES OF HEALTH 
NIH News 
National Institute of Mental Health (NIMH)
http://www.nimh.nih.gov/

EMBARGOED FOR RELEASE: Wednesday, March 22, 2006; 5:00 p.m. ET

CONTACT: NIMH Press Office, 301-443-4536, NIMHpress@xxxxxxx

NEW STRATEGIES HELP DEPRESSED PATIENTS BECOME SYMPTOM-FREE

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:

-- Stephen Wisniewski, Ph.D., University of Pittsburgh

-- Andrew Nierenberg, M.D., Massachusetts General Hospital

-- Diane Warden, Ph.D., University of Texas Southwestern Medical Center

-- Louise Ritz, M.B.A., NIMH

-- Grayson Norquist, M.D., University of Mississippi

-- Robert Howland, M.D., University of Pittsburgh

-- Barry Lebowitz, Ph.D., University of California, San Diego

-- Patrick McGrath, M.D., Columbia University

-- Kathy Shores-Wilson, Ph.D., University of Texas Southwestern Medical
Center

-- Melanie Biggs, Ph.D., University of Texas Southwestern Medical Center

-- G.K. Balasubramani, Ph.D., University of Pittsburgh

-- Maurizio Fava, M.D., Massachusetts General Hospital 

For more information on STAR*D level 2, visit:

-- Primary Results for Sequenced Treatment Alternatives to Relieve
Depression (STAR*D) Study
(http://www.nimh.nih.gov/healthinformation/stard.cfm)

-- Questions and Answers about the NIMH Sequenced Treatment Alternatives
to Relieve Depression (STAR*D) Study -- Level 2 Results, Published in
New England Journal of Medicine, March 23, 2006
(http://www.nimh.nih.gov/healthinformation/stard_qa_level2.cfm)

For more information on STAR*D level 1, visit:

-- Initial Results Help Clinicians Identify Patients With
Treatment-Resistant Depression (http://www.nimh.nih.gov/press/stard.cfm)

-- Questions and Answers about the NIMH Sequenced Treatment Alternatives
to Relieve Depression (STAR*D) Study -- Level 1 Results, Published in
American Journal of Psychiatry, January 1, 2006
(http://www.nimh.nih.gov/healthinformation/stard_qa_level1.cfm)

For general information on the STAR*D study, visit:

-- Sequenced Treatment Alternatives to Relieve Depression at
ClinicalTrials.gov
(http://www.clinicaltrials.gov/ct/show/NCT00021528?order=1)

-- Questions and Answers about the NIMH Sequenced Treatment Alternatives
to Relieve Depression (STAR*D) Study - Background
(http://www.nimh.nih.gov/healthinformation/stard_qa_general.cfm)

-- PATIENT GUIDE: New Strategies for Treating Depression
(http://www.nimh.nih.gov/healthinformation/stard_guide.cfm)

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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This NIH News Release is available online at:
http://www.nih.gov/news/pr/mar2006/nimh-22.htm.

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