Treatment for depression study sees third of subjects reach remission after first phase

[Guest guest]

Public release date: 1-Jan-2006

Contact: Donna Steph Hansard

donna.hansard@...

UT Southwestern Medical Center

Treatment for depression study sees third of subjects reach remission

after first phase

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UT Southwestern served as the national coordinating center for the

largest clinical trial on treatments for depression. Dr. A. Rush,

(left), vice chairman for research in psychiatry, was the study's

principal investigator and Dr. Madhukar Trivedi, professor of

psychiatry, was the lead author of the first phase-one study results.

Credit: Gresham

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Phase one of a four-phase, six-year study on treatments for depression

– the largest of its kind and led by researchers at UT Southwestern

Medical Center – showed nearly half fully recovered from their

symptoms or had major improvement after treatment with an

antidepressant medication.

Results of the study, involving nearly 3,000 patients at 41 sites,

appear in the January issue of the American Journal of Psychiatry,

include:

A third of patients with major depressive disorder (MDD), when

initially treated with a class of antidepressant medication called a

selective serotonin reuptake inhibitor (SSRI) using specific

guidelines and dosage amounts, fully recovered from their symptoms.

Another 10 percent to 15 percent showed a response to the medication,

or reduction of at least half their symptoms.

Patients suffering from depression responded similarly whether treated

by a primary-care doctor or a psychiatrist when both followed the same

treatment strategies.

Study participants – who were treated in " real-world " clinics for

depression, as well as other medical and psychiatric conditions –

responded similarly to medication as did individuals in earlier

clinical trials who volunteered for studies and typically had no other

medical problems.

The highest response and remission rates came from study participants

who were Caucasian, female, employed, and had higher levels of

education or income.

While additional results are yet to be published from phase two

through phase four of the $35 million clinical trial designated STAR*D

(Sequenced Treatment Alternatives to Relieve Depression), these first

findings are significant because of the size and scope of the study,

and because there is limited information currently available on

successfully treating people with depression. STAR*D was funded by the

National Institute of Mental Health (NIMH).

STAR*D was designed to focus on " real-world " patients with depression

and help determine the most effective treatment strategies,

particularly when individuals didn't respond to the first

antidepressant medication tried. While there are numerous effective

treatment options for depression – including nearly 20 Food and Drug

Administration-approved antidepressants and several scientifically

tested psychotherapies – no one treatment universally works. And, many

people do not experience a satisfactory result from the first

treatment used.

" STAR*D is important because it represents the largest group of

moderately to severely depressed patients studied, most of whom had

either chronic or recurrent major depression, and the majority of whom

also had concurrent other general medical or psychiatric disorders, "

said Dr. A. Rush, vice chairman for research in psychiatry at UT

Southwestern and STAR*D's principal investigator.

" What's also important is that nearly half of these patients

significantly benefited from and showed a response to the medication,

with one in three of those achieving a symptom-free state, after the

first round of medication, " Dr. Rush said.

Each year, about 19 million American adults – or 9.5 percent of the

population – struggle with depression. MDD is a recurring and chronic

illness, frequently returning for two or more episodes, each usually

lasting two years or more. Depression is currently the fourth-most

disabling illness worldwide and cost the United States an estimated

$83 billion in the year 2000.

" In the field of depression treatment, the burning question is, 'What

are the best approaches for treatment of depression and more

importantly, what are the next subsequent steps to take if the first

one doesn't lead to full remission?' " said Dr. Madhukar Trivedi,

professor of psychiatry at UT Southwestern and lead author of the

phase-one study.

" What's exciting about STAR*D is that it's the first large clinical

trial where we entered into the community of practitioners who were

not doing research studies themselves, but were routinely treating

patients with depression, both in primary care and specialty care, " he

said. " Rather than evaluate individuals who volunteer for studies –

usually conducted for the purpose of FDA approval of a medication –

these were patients already being treated for depression and often

having other multiple illnesses and psychiatric conditions. The

results from this study can thus easily be transferred to routine

clinical practice in both primary and specialty care. "

In the first phase of STAR*D, nearly 3,000 patients in 23 psychiatric

and 18 primary-care clinics were given the antidepressant Citalopram

(brand name Celexa) for up to 14 weeks. Clinicians evaluated patients

at each visit for depressive symptoms and possible medication side

effects and, using a " measurement-based care " treatment manual, could

modify patient dosages based on each person's symptoms and side

effects.

Of those studied, 33 percent achieved remissions (the virtual absence

of symptoms) and a total of 47 percent showed a response rate (had

symptoms reduced by at least half). Higher remission rates were found

in Caucasians; women; better-educated and higher-income participants;

individuals with private insurance, fewer other medical and

psychiatric problems, better pre-treatment physical and mental

function, greater satisfaction with life and shorter current

depressive episodes. Being married or living with someone also

appeared to have a positive effect.

" There does seem to be a group of social, demographic and clinical

factors that may predict a better outcome when treating depression, "

Dr. Trivedi said.

Patients who did not achieve remission in the STAR*D's phase-one trial

were encouraged to continue. In phase two, participants were offered

seven different treatment alternatives including switching to

different medications or trying psychotherapy, or adding another

medication or psychotherapy. Additional treatment options were

available in phases three and four for patients who still did not

become symptom-free. No placebo treatments were used in the study.

Researchers at 14 medical institutions worked together under the

direction of UT Southwestern as the national coordinating center.

Their goal is to provide better guidelines to clinicians in dealing

with depressed patients, particularly in helping them decide which

treatment strategies are the most effective when patients do not reach

remission after one or more treatments. These guidelines also should

help determine optimal medication dosage needed and how long a

treatment strategy should be used before deciding it is ineffective

and changing to another.

" One of the likely reasons we saw such positive results in this trial

is because of the diligent management of patients, " said Dr. Rush.

" This approach, called measurement-based care, utilized routine

measurement of symptoms and side effects to guide treatment dosing,

and can be easily implemented in busy primary care and psychiatric

practices. "

Also participating from UT Southwestern in this phase-one study were

Dr. Diane Warden, assistant professor of psychiatry, Dr. Kathy

Shores-, adjunct assistant professor of psychiatry, and Dr.

M. Biggs, associate professor of family and community medicine

and psychiatry. In addition, researchers from the Epidemiology Data

Center, Graduate School of Public Health, University of Pittsburgh;

Depression Clinical and Research Program, Massachusetts General

Hospital; NIMH; Department of Psychiatry, University of Mississippi;

Department of Psychiatry, University of Pittsburgh School of Medicine;

The Sam and Rose Stein Institute for Research on Aging, University of

California, San Diego, School of Medicine; the New York State

Psychiatric Institute and Department of Psychiatry, College of

Physicians and Surgeons of Columbia University; and the STAR*D study

team were included.

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This news release is available on our World Wide Web home page at

http://www.utsouthwestern.edu/home/news/index.html

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Regards,