Andy Health blog

Forest Laboratories, Inc.
(NYSE: FRX) announced that study results show Lexapro (escitalopram
oxalate) significantly improved symptoms of depression as compared to
placebo treatment and was well tolerated in adolescents, aged 12-17, with
major depressive disorder (MDD), according to phase III data presented at
the 2008 Annual Meeting of the American Psychiatric Association. These
results suggest that Lexapro has potential as a useful treatment option for
adolescents with depression. Top-line results of this study were initially
released in November 2007.
"Treating depression in adolescents can be particularly challenging
because few antidepressants have demonstrated efficacy in clinical trials
in this population," said Graham Emslie, MD, Professor of Psychiatry at the
University of Texas Southwestern Medical Center in Dallas. "In this study,
Lexapro significantly improved depressive symptoms in adolescents with MDD,
and was also well tolerated by study participants."
Researchers estimate that up to eight percent of adolescents are
affected by depression. Depression is a chronic disease that requires
medical treatment. However, FDA-approved treatment options for this
population are limited. Lexapro is not currently approved by the FDA for
use in pediatric or adolescent patients.
Based on the results of this study, Forest plans to file for an
adolescent depression indication for Lexapro this year.
Study Results
A double-blind, parallel-group, placebo-controlled phase III study to
evaluate the safety and efficacy of Lexapro in the treatment of depressed
adolescents, aged 12-17, was conducted in multiple centers across the U.S.
A total of 316 patients entered the eight week study, receiving either
Lexapro 10-20 mg (n=158) or placebo (n=158). The primary endpoint was
change from baseline to Week 8 on the Children’s Depression Rating Scale -
Revised (CDRS-R) using last observation carried forward (LOCF) approach.
The CDRS-R is a commonly used clinician-rated instrument that covers 17
symptom areas of depression relevant to adolescents, including impaired
schoolwork, difficulty having fun, social withdrawal, physical complaints,
and low self-esteem. The study showed statistically significant improvement
in patients treated with Lexapro relative to placebo based on the change
from baseline in the Buy generic amoxil CDRS-R score (-22.1 for Lexapro vs. -18.8 for placebo
treatment; p=0.022).
The trial also showed that Lexapro was generally well-tolerated.
Discontinuation rates due to adverse events were 2.6 percent and 0.6
percent for patients receiving Lexapro and placebo, respectively. Serious
adverse events were reported by 2.6 percent of patients receiving Lexapro
and 1.3 percent for patients receiving placebo. The most commonly reported
adverse events (greater than 10 percent in either group) were headache (25
percent in Lexapro patients vs. 26 percent with placebo), menstrual cramps
(11 percent vs. 15 percent placebo), nausea (10 percent vs. 8 percent
placebo), insomnia (10 percent vs. 6 percent placebo) and inflicted injury
(9 percent vs. 13 percent placebo), the majority of which were accidental
in nature. The only adverse event occurring at a frequency of greater than
or equal to 5 percent and with an incidence for Lexapro treated patients
twice that of placebo treated patients was influenza-like symptoms (7
percent vs. 3 percent placebo).
Depression and Adolescents
Adolescent depression is characterized by persistent sadness and loss
of interest in usual activities. While the brain chemistry of depression is
not fully understood, research suggests that depression is caused by an
imbalance of certain chemicals in the brain, most notably serotonin.
Despite advances and progress in identifying and treating mental
disorders in adolescents, depression in this population remains
under-treated. Depression is a chronic disease that requires medical
attention and treatment, and if left untreated, may have serious
consequences. According to the National Alliance on Mental Illness (NAMI),
adolescents with untreated depression are likely to have ongoing problems
in school, at home and with their friends.
For adolescents who suffer from depression, psychotherapy,
cognitive-behavior therapy, interpersonal therapy and medication play an
important role in the management of their illness. Patients on
antidepressant treatment should also be closely monitored by healthcare
providers, family members and other caregivers.
About Lexapro
Lexapro is an SSRI being studied as a treatment for adolescents with
MDD. Lexapro is indicated for the initial and maintenance treatment of
major depressive disorder and generalized anxiety disorder (GAD) in adults.
Lexapro is thought to work by helping to restore the brain’s chemical
balance. It is believed to increase the availability of serotonin, a
substance in the brain believed to influence mood. In adults, Lexapro 10
mg/day is a well-tolerated therapy, with drop-out rates due to adverse
events comparable to placebo treatment in depression trials. Lexapro has
been prescribed to over 16 million people.
Important Lexapro Information
Depression and certain other psychiatric disorders are themselves
associated with increases in the risk of suicide. Antidepressants increased
the risk of suicidality (suicidal thinking and behavior) in children,
adolescents, and young adults in short-term studies of major depressive
disorder (MDD) and other psychiatric disorders. Anyone considering the use
of antidepressants in children, adolescents or young adults must balance
the risk to clinical need. Patients of all ages started on antidepressant
therapy should be closely monitored and observed for clinical worsening,
suicidality or unusual changes in behavior, especially at the beginning of
therapy or at the time of dose changes. This risk may persist until
significant remission occurs. Families and caregivers should be advised of
the need for close observation and communication with the prescriber.
Lexapro is not approved for use in pediatric patients.
Lexapro is contraindicated in patients taking monoamine oxidase
inhibitors (MAOIs), pimozide (see DRUG INTERACTIONS - Pimozide and Celexa),
or in patients with hypersensitivity to escitalopram oxalate. As with other
SSRIs, caution is indicated in the coadministration of tricyclic
antidepressants (TCAs) with Lexapro. SSRIs and SNRIs (including Lexapro)
and other psychotropic drugs that interfere with serotonin reuptake may
increase the risk of bleeding events. Concomitant use of aspirin, NSAIDs,
warfarin and other anticoagulants may add to the risk. Patients should be
cautioned about these risks. SSRIs and SNRIs have been associated with
clinically significant hyponatremia. Elderly patients or patients taking
antidiuretics or who are otherwise volume-depleted appear to be at a
greater risk. Discontinuation of Lexapro should be considered in patients
with symptomatic hyponatremia and appropriate medical intervention should
be instituted. The most common adverse events with Lexapro versus placebo
(approximately 5 percent or greater and approximately twice that of
placebo) were nausea, insomnia, ejaculation disorder, somnolence, increased
sweating, fatigue, decreased libido, and anorgasmia. Further information on
Lexapro is provided in the FDA approved Package Insert.
About Forest Laboratories and Its Products
Forest Laboratories is a US-based pharmaceutical company dedicated to
identifying, developing, and delivering products that make a positive
difference in people’s lives. Forest Laboratories’ growing product line
includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults
for the initial and maintenance treatment of major depressive disorder and
generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl-D-
aspartate (NMDA)-receptor antagonist indicated for the treatment of
moderate to severe Alzheimer’s disease; Campral(R)* (acamprosate calcium),
indicated in combination with psychosocial support for the maintenance of
abstinence from alcohol in patients with alcohol dependence who are
abstinent at treatment initiation; and Bystolic(TM) (nebivolol), a
beta-adrenergic receptor blocking agent indicated for the treatment of
hypertension. In addition to our growing product line, Forest also
co-promotes the Daiichi Sankyo, Inc. product Azor(TM) (amlodipine and
olmesartan medoxomil), a calcium channel blocker and angiotensin receptor
blocker combination product indicated for the treatment of hypertension.
For more information, visit
Azor is a trademark of Daiichi Sankyo, Inc. and Campral is a
registered trademark of Merck Sante s.a.s., a subsidiary of Merck KGaA,
Darmstadt, Germany.
Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, the timely development and
launch of new products, and the risk factors listed from time to time in
the Forest Laboratories’ Annual Report on Form 10-K, Quarterly Reports on
Form 10-Q, and any subsequent SEC filings.
Forest Laboratories, Inc.

View drug information on Azor; Campral; Lexapro.
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Technology can send a man to the moon, help unlock the secrets of DNA and let people around the world easily communicate through the Internet. But can it substitute for nature?
Apparently not, according to a new study that measured individuals’ heart recovery rate from minor stress when exposed to a natural scene through a window, the same scene shown on a high-definition plasma screen, or a blank wall. The heart rate of people who looked at the scene through the window dropped more quickly than the others. In fact, the high-definition plasma screen had no more effect than the blank wall.
In addition, the research done through the Human Interaction with Nature and Technological Systems Lab at the University of Washington showed that when people spent more time looking at the natural scene their heart rates tended to decrease more. That was not the case with the plasma screen.
The study, funded by the National Science Foundation, is published in the current issue of the Journal of Environmental Psychology.
"Technology is good and it can help our lives, but let’s not be fooled into thinking we can live without nature," said Peter Kahn, a UW associate professor of psychology who led the research team.
"We are losing direct experiences with nature. Instead, more and more we’re experiencing nature represented technologically through television and other media. Children grow up watching Discovery Channel and Animal Planet. That’s probably better than nothing. But as a species we need interaction with actual nature for our physical and psychological well-being."
Part of this loss comes from what the researchers call environmental generational amnesia. This is the idea that across generations the amount of environmental degradation increases, but each generation views conditions it grew up with as largely non-degraded and normal. Children growing up today in the cities with the worst air pollution often, for example, don’t believe that their communities are particularly polluted.
"This problem of environmental generational amnesia is particularly important for children coming of age with current technologies," said Rachel Severson, a co-author of the study and a UW psychology doctoral student. "Children may not realize they are not getting the benefits of actual nature when interacting with what we’re calling technological nature."
To see how people reacted to nature and a technological representation of it, the researchers recruited 90 college students to participate in an experiment that had them work on four mental tasks while sitting at a desk in an office. With 30 of the students, the desk faced a window overlooking a campus scene that included a large fountain and trees. For a second group of 30 students, the window was replaced with the plasma screen that showed the same nature scene in real time. For the remaining 30 students, curtains covered the plasma screen and the desk faced a blank wall.
Participants were tested individually. Each was welcomed by a researcher, hooked up to a heart rate monitor and told to wait for five minutes while the researcher stepped out of sight. A camera mounted on the wall near the window or plasma screen was synchronized with the heart monitor and tracked participants’ eye movements. At the end of the waiting period, the researcher returned, explained the first task and stepped out of sight. This was repeated for the remaining three tasks and then the subject was told to wait again for five minutes.
generic cialis online buy Heart recovery rate was based on how quickly each participant’s heart rate dropped in the 60 seconds after being told to wait or to have one of the tasks explained. Each person’s performance was tallied on the basis of six measurements, once after every task and the two waiting periods. Low-level stress was created by having to deal with another person in a social situation and the anticipation or performance anxiety each might have experienced to do well on the four tasks.
The researchers found that participants with the plasma screen actually looked at it just as often as did those who had the window. However, the window held the students’ attention significantly longer than the plasma screen did. When participants spent more time looking at the window, their heart rates decreased faster than on tasks when they spent less time looking at the window. This was not true with the plasma screen.
"I was surprised by this," said Kahn. "I thought the plasma screen would come somewhere between the glass window and the blank wall. This study is important because it shows the importance of nature in human lives and at least one limitation of technological nature.
"In the years ahead, technological nature will get more sophisticated and compelling. But if it continues to replace our interaction with actual nature, it will come at a cost. To thrive as a species, we still need to interact with nature by encountering an animal in the wild, walking along the ocean’s edge or sleeping under the enormity of the night sky."
—————————-
Article adapted by Medical News Today from original press release.
—————————-
Co-authors of the study are Batya Friedman, Jennifer Hagman, Erika Feldman and Anna Stolyar of the UW, Brian Gill of Seattle Pacific University, Nathan Freier of Rensselaer Polytechnic Institute and Sybil Carr??»re of California State University, San Bernardino. Freier and Carr??»re were both at the UW when they worked on the study.
More information about the Human Interactions with Nature and Technological Systems Lab is available at
Source: Joel Schwarz
University of Washington
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The post-university years can start out tough. The good news: it gets better.
A new University of Alberta study of almost 600 of its graduates (ages 20-29 years old) tracked mental health symptoms in participants for seven years post-graduation and looked at how key events like leaving home and becoming a parent were related to depression and anger. Graduates showed a significant decrease in depressive symptoms over the seven years. Expressed anger also declined over time after graduation, suggesting improved mental health.
The researchers also found that while home may be a haven for young people in the early years of adulthood, the longer they stay at home, or if they return home, the more likely they are to experience symptoms of depression. Previous research has found that more than half of students under 25 in four-year university programs lived with their parents.
In this study, it was shown that younger participants were more depressed at times when they lived on their own, while older participants were more depressed while they lived with their parents.
"Generic soma pills no prescription Some key events, such as leaving home, may throw emerging adults a little off kilter, depending on the timing of the transition," said Nancy Galambos, University of Alberta psychology professor. "Leaving home too soon can be challenging in ways that have the potential to affect mental health."
It was revealed that women were more depressed and angry at the start of the study than men. Also, anger increased when participants became parents.
"Although we generally welcome parenthood as a positive experience, we found that people who became parents became angrier, and this was especially pronounced for mothers," said Harvey Krahn, University of Alberta chair of sociology. "The transition to parenthood produces a new set of demands on the couple that may be difficult to cope with as parents have to negotiate a whole new set of family responsibilities."
—————————-
Article adapted by Medical News Today from original press release.
—————————-
The study was conducted by Nancy Galambos, University of Alberta psychology professor, and Harvey Krahn, University of Alberta chair of sociology. It appears in the Journal of Marriage and Family.
Source: Kris Connor
University of Alberta
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