Feature

Saturday, July 05, 2008

Recurrence of Late-Life Depression Preventable

  Forest Laboratories Announces Longest Study Is First of SSRI in Late-Life
   Depression Prophylaxis

    CHICAGO, May 17  -- Long-term treatment with the selective
serotonin reuptake inhibitor (SSRI) Celexa(TM) (citalopram HBr) helped prevent
the recurrence of major depression in patients at least age 65, many of whom
had multiple health problems, researchers reported here today at the 153rd
annual meeting of the American Psychiatric Association (APA).
    Based on clinical trial data, Forest Laboratories recently submitted a
Supplemental New Drug Application to the U.S. Food and Drug Administration
seeking a new indication for Celexa for the prevention of depression
recurrence.
    About 60 to 70 percent of patients aged 60 years or older are likely to
experience a recurrence within two years of their first depressive episode,
compared with 30 percent of patients aged 20 to 30 years.  Few risk factors
that might predict which individuals are more likely to experience recurring
episodes of late-life depression have been identified.
    The National Institute of Mental Health has called depression in seniors a
"public health crisis," and asserts the importance of treating depression in
this age group.  According to Dr. Barry D. Lebowitz, chief of the adult and
geriatric treatment and preventive interventions branch of the National
Institute of Mental Health, "It is not normal to be old and sad.  Depression
is a biologically based illness that can and should be treated.
    "However, the treatment of depression in older people is complicated by a
variety of factors, including the patient's age, likelihood of concurrent
illness, and the probability that depression will recur," Dr. Lebowitz said.
"The higher rate of recurrence for seniors following a full recovery means
that depression can become a life-long problem for them, thereby negatively
affecting their quality of life and hastening mortality."
    An estimated 15 percent of older people in the United States suffer from
symptoms of depression serious enough to impair daily functioning.  The
condition is associated with more negative outcomes of concomitant illnesses,
as well as an increased risk of mortality, either because of an increased
chance of death from physical disease or because of the high risk of suicide
among older depressed people.

    Study Conclusions
    Researchers presented findings from a study of the effectiveness of Celexa
in the treatment of depression and the prevention of recurrent episodes in
individuals aged 65 and older.  The study, which followed patients for up to
two years, involved 230 depressed individuals who initially were treated with
Celexa for eight weeks.  A total of 121 patients who responded to Celexa
during the acute treatment phase and remained well during the continuation
phase (16 weeks) were then randomized to receive either Celexa or placebo for
a minimum of 48 weeks during the double-blind, placebo-controlled period to
evaluate the drug's effect on prevention of recurrence.
    The study found that long-term maintenance treatment with Celexa
(administered in doses of 20 to 40 mg per day) was significantly more
effective than placebo in preventing recurrence of depressive episodes.
Patients were assessed for depressive symptoms at weeks two and four and then
every four weeks throughout the follow-up period.
    The data are significant not only because they are robust, but also
because this is the first study that evaluates the use of an SSRI to prevent
depression recurrence in this patient population.  The study also is important
because its two-year follow-up period is longer than that of similar studies
involving other antidepressants.

    Study Participants
    The mean age of patients in the placebo-controlled phase of the study was
approximately 74 years.  About 72 percent of patients in the study were
diagnosed with physical health problems in addition to depression.  All the
study participants lived in the community, rather than in an institution such
as a nursing home.

    Separate Study in Patients Greater Than or Equal to 75 Years Old is
    Ongoing
    A separate study evaluating the efficacy of Celexa in depressed
individuals age 75 and older is currently enrolling participants.  This is the
first, multi-center, placebo-controlled study of depression in the so-called
"old-old," who make up the fastest-growing segment of the U.S. population.
Individuals who think they may be eligible can contact the sites directly:

    1. Allied Clinical Trials, Inc., Miami, 305-545-6400
    2. Atlanta Center for Medical Research, 404-292-2000
    3. Brown University-Butler Hospital, 401-455-6430
    4. Comprehensive Clinical Research, P.C. - New Jersey, 856-753-7335, x20
    5. Duke University Medical Center, 919-684-5616
    6. Harvard University, 617-232-1113
    7. The New York Hospital-Cornell Medical Center, 914-997-5767
    8. Columbia University-New York State Psychiatric Institute, 212-543-5749
    9. Pivotal Research Centers - Arizona, 623-815-9714
   10. St. Louis University, 314-577-8721
   11. UCLA School of Medicine, 310-825-0291
   12. University of Nebraska Medical Center, 402-559-5012
   13. University of Pennsylvania, 215-349-8226
   14. University of Pittsburgh, Western Psychiatric Institute and Clinic,
       412-624-6846
   15. Yale New Haven Medical Center, 203-688-2157

    About Celexa
    Celexa has been shown to be safe and effective in many large-scale
clinical trials involving patients with mild to moderate depression.  Because
Celexa has little or no potential to inhibit the metabolism of other drugs, it
may be an especially useful antidepressant for older or medically complicated
patients.  More than 20 million patients have been prescribed Celexa, which
currently is available in 69 countries.
    Among Celexa-treated patients in clinical trials reporting side effects,
those most frequently reported were nausea, dry mouth, and sleepiness.  As
with all SSRIs, Celexa should not be taken together with monoamine oxidase
inhibitors.
    Developed by the Danish pharmaceutical firm H. Lundbeck AS, citalopram is
marketed in Europe as Cipramil(R).  Celexa is the fastest-growing SSRI in the
United States and is the top-selling antidepressant in 13 countries, in which
three or more SSRIs are available.
    Full prescribing information about can be found on the Internet at
http://www.celexa.com .