Adjunctive antidepressant use was associated with significantly higher mania symptom severity at the 3-month follow-up. The probability of recovery at 3 months was lower among patients with higher baseline depression severity. Antidepressant use neither hastened nor prolonged time to recovery once potential confounding factors were covaried in a Cox regression model. CONCLUSIONS: In bipolar depression accompanied by manic symptoms, antidepressants do not hasten time to recovery relative to treatment with mood stabilizers alone, and treatment with antidepressants may lead to greater manic symptom severity. These findings are consistent with those from the STEP-BD randomized trial for pure bipolar depression, in which adjunctive antidepressants did not yield higher recovery rates than did mood stabilizer monotherapy

The findings of the study includes birth defect risks like congenital heart disease, which was once associated with the use of SSRI in earlier studies. However, researchers have also found out that there were associations between the use of SSRI and three definite defects in birth. These defects involve the brain, one kind of abnormality in development of the skull and in the gastrointestinal organ.

According to CDC’s epidemiologist, Jennita Reefhuis, the overall results of their studies were generally encouraging, especially regarding the issue of antidepressants use for the duration of pregnancy. Reefhuis is also among the group of authors that spearheaded the study.

Reefhuis further stipulated that it is known that the mother and infant both benefit once the pregnant women who has critical depressive illness manages to stay with certain treatment. The threats have differences according to various SSRIs and categorization of women.

Reefhuis stated that it is important for the pregnant women to discuss the benefits and risks of SSRI medication during the time of their pregnancy. She also noted that even if their study have found some association between the increased threat of having three explicit birth defects associated with SSRI use, the increase are actually minimal and were not discovered previously on studies concerning same issue

A second SSRI study in connection with birth defects that was published by NEJM on June 28 that has not found any such association with overall birth defects. On the other hand, it found important connections between certain SSRIs and a number of birth defects.

Reefhuis declared that for every pregnancy there is a 3 percent risk of having defects during birth, without regard to exposures to antidepressants. There is a lifetime risk for women to acquire major depression by 10 – 25 percent. The highest prevalence of this is when they are in their childbearing years of during 18 – 44 years old.

The CDC has intentions of continuing their study the associations of SSRI and risks of birth defects in order to shed light on whether there is a true risk existing with the antidepressant use while pregnant.

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Mark Zimmerman, MD, director of outpatient psychiatry at Rhode Island Hospital and associate professor of psychiatry and human behavior at the Warren Alpert School of Medicine at Brown University, is the paper’s lead author. Zimmerman, along with his colleague Tavi Thongy, MD, also of Rhode Island Hospital and Brown University, conducted a meta-analysis of continuation studies of new generation antidepressants that began as placebo-controlled acute phase studies. Treatment studies of depression have found that approximately 50 to 65 percent of patients respond to medication and that approximately 25 to 35 percent respond to placebo.

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Past studies have indicated that a number of patients who respond to treatment in the initial phase experience a relapse or recurrence despite ongoing pharmacotherapy during the two latter phases of treatment. This return of symptoms is often interpreted as a loss of efficacy of antidepressant activity, and is referred to as tachyphylaxis or the “poop-out” effect.

Zimmerman says, “When a patient improves after being prescribed an antidepressant medication you do not know if they got better because of the medication or because they had a placebo response.”

The researchers used formulas developed by Quitkin and colleagues more than a decade ago to calculate the relapse rate attributable to relapse in presumptive placebo responders. “Our study suggests that the return of symptoms despite ongoing treatment during the continuation and maintenance phases of treatment may not represent a loss of drug effect because the patient may not have experienced a true drug response in the first place.”

Zimmerman also notes, “While our conclusion is limited to the continuation phase of treatment, our results suggest that these findings probably also apply to the maintenance phase of treatment.”

The researchers note that these findings are not inconsistent with conclusions that continuation and maintenance studies of antidepressants have clearly established the benefit of ongoing treatment beyond the acute phase.

Net income leapt over 230% to 498 million kroner, about $90.3 million, while revenues were up 19% to 2.61 billion kroner. Sales of the blockbuster Lexapro (escitalopram), sold in the USA by licensee Forest Laboratories, drove growth again, with sales rising 47% to 641 million kroner, while turnover of Lundbeck’s own Cipralex brand of the antidepressant advanced 20% to 1.03 billion kroner.

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The Alzheimer’s disease drug Ebixa (memantine) climbed 21% to 409 million kroner and two of the firm’s newer products - Azilect (rasagiline) for Parkinson’s disease and Serdolect (sertindole) for schizophrenia - contributed 40 million and 6 million kroner, respectively.

A reasonable set of results on the face of it, but investors are not impressed and at 10am, its share price was down 3.3% to 132.50 kroner as pipeline worries pervaded the financial figures. The company remains exposed to the weak US dollar and looming patent expiries starting in 2012 of Cipralex and Lexapro.

The company also recently announced disappointing Phase III data for the new stroke drug desmoteplase, which came a couple of months after Lundbeck and partner Merck & Co said that data from Phase III studies suggested that the clinical profile for gaboxadol in insomnia did not support further development.

“Depression is hard . . . it hurts in so many ways,” says the announcer in a 60-second commercial.

If you missed the stark, powerful commercial for Eli Lilly and Co.’s antidepressant Cymbalta, you won’t have to wait long for it to roll around again — or another one like it. The branding effort, now 2 years old, is designed to make Cymbalta a household name on a par with Prozac, an older antidepressant and Lilly’s top-selling drug before its patent expired in 2001. Last year, Lilly shelled out $157.1 million on consumer advertising about Cymbalta, and the investment is paying off.

After just three years on the market, Cymbalta has become Lilly’s fastest-growing drug and its No. 2 seller overall. Sales nearly doubled last year to $1.3 billion worldwide, and they’re up 77 percent for the first six months of this year.

In the process, Cymbalta is grabbing market share from established competitors, including Wyeth Pharmaceuticals, maker of Effexor, and Forest Laboratories, which makes Lexapro.

Antidepressants are a huge category for pharmaceutical companies. The U.S. market was $16.2 billion in 2005 and is growing by about 5 percent a year, according to Espicom Healthcare Intelligence.

But consumer groups and medical professors long have criticized direct-to-consumer advertising of drug brands, saying it relies on emotion, overstates the benefits and understates side effects.

“People go to their doctor, ask for something they’ve seen on TV, and that leads to over-prescribing, over-medicating of America, and a horrendous waste of money,” said Bill Vaughn, a senior policy analyst for health care at Consumers Union, publisher of Consumer Reports magazine.

Lilly says the Cymbalta commercials help people suffering from depression realize they are not alone and should reach out.

“Patients have told us, “Finally, someone understands what I’m going through,’ ” said Phyllis Ferrell, Cymbalta marketing director.

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The first phase of Lilly’s “Depression Hurts” marketing effort was an unbranded campaign focusing just on the disease, which affects about 121 million people worldwide.

The company launched the brand portion of the campaign in April 2006, introducing viewers to Cymbalta as the answer to depression and its related aches and pains.

The catchphrases from its series of commercials (”Where does depression hurt? Everywhere. Who does depression hurt? Everyone.”) have caught on, with imitations and parodies on YouTube and in blogs.

By the end of the 60-second ads, the patients have taken their Cymbalta and are getting their lives together. Carol, the woman who wouldn’t answer the phone, has brushed her hair, put on a nice sweater and is smiling and answering her phone.

Lilly’s Web site on the topic (www.depressionhurts.com) includes an interactive checklist of symptoms; a three-dimensional portrayal of chemical pathways in the brain and nervous system that regulate mood; patient stories and treatment options. Lilly also gives patients a glossy, 36-page booklet on depression treatment, with tips for feeling better, along with some emotional punch. One page shows a sad-eyed dog waiting for its master, who is suffering from depression, to take it for walks again.

The Web site, TV commercials and print ads have garnered an armload of awards in marketing contests. But some psychiatrists question whether Cymbalta is really the best medicine.

“Yes, depression often does include physical pain, and as your depression improves, your pain often improves,” said Dr. Daniel Carlat, a Massachusetts psychiatrist. “But whether Cymbalta is actually more effective for treating this pain hasn’t been proven in crucial head-to-head tests with other drugs.”

Lilly concedes that point, but adds that Cymbalta is the only antidepressant that has been approved for pain. The FDA approved the drug for treatment of diabetic peripheral neuropathic pain, a condition that affects about 5 million Americans

The finding addresses a key issue in mental health research: the differences in people’s responses to antidepressant medications, thought to be based partly on differences in their genes. Some patients respond to the first antidepressant they attempt, but many don’t. Each medication takes weeks to exert its full effects, and patients’ depression may worsen while they search for a medication that helps. Genetic studies, such as the one described here, may lead to a better understanding of which treatments are likely to work for each patient.

Results of the study are in the August issue of the American Journal of Psychiatry, reported by lead researcher Francis J. McMahon, MD, Silvia Paddock, PhD, of NIMH, and colleagues. Scientists from the National Human Genome Research Institute, the National Institute on Alcohol Abuse and Alcoholism, Mount Sinai School of Medicine, and University of Texas Southwestern Medical Center also contributed to the research.

“We’re moving steadily closer to being able to personalize treatments based on patients’ genetic variations. This is a crucial need for the millions of Americans who suffer from depression,” said NIMH Director Thomas R. Insel, MD. “New techniques have led to advances that would have been inconceivable a few years ago and are making individualized treatment an achievable goal.”

The researchers studied DNA provided earlier by patients participating in a recently completed NIMH clinical trial, the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. The trial showed that depressed patients who don’t benefit from the first medication they try have a fair chance of being helped by others.

After the trial, researchers spelled out the DNA codes contained in 68 genes suspected of being involved in depression, collected from 1,297 of the patients who had participated in STAR*D. The genetic material included the occasional variations that occur from person to person. Comparing the DNA codes of those who had responded to citalopram and those who hadn’t, the scientists found that responders were more likely to have a variation in a gene called HTR2A. Results of that study were published in May 2006.

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In the newest study, researchers examined the genetic material of more of the patients who had participated in STAR*D, for a total of 1,816 samples, and repeated the comparison of DNA from citalopram responders and nonresponders. They discovered that people with the variation in the GRIK4 gene had a higher likelihood of response, and again found that the variation in the HTR2A gene also made people more likely to respond. The results were reproduced, strengthening their validity.

The protein produced by HTR2A acts as a receptor on brain cells for the chemical messenger serotonin, one of several neurotransmitters that enable the cells to communicate with each other. The discovery that a variation in a serotonin-related gene could affect response to citalopram was not entirely surprising, since the serotonin system is known to be involved in depression. Citalopram targets this system.

But GRIK4 makes a protein that acts as a receptor in a different neurotransmitter system, the glutamate system. Recent studies suggest that the glutamate system also is involved in depression, an assertion supported by the new finding.

“We know that a number of biological mechanisms underlie depression and affect treatment. Findings like this one are building a picture of what they are and how they interact, and can reveal potential molecular targets for faster-acting and more effective medications,” said McMahon. Both of the genes consist of two copies each. The 23 percent increase in likelihood of response to citalopram occurred in people who carried the favorable variations in both copies of both of the genes. People with fewer of the favorable variations didn’t have as high a response rate, but still were more likely to respond than were people with none of the favorable variations.

By using a recent technique called “SNP tags,” the researchers used fewer resources, in less time, than usually required for these kinds of studies. SNP tags eliminated the need to compare all of the millions of structural units that comprise even a tiny segment of DNA — a resource- and time-intensive process — by organizing the units into more manageable blocks of information.

The research, conducted by the National Institute of Mental Health, focused on how ketamine, when used experimentally for depression, relieves symptoms in hours instead of the weeks or months it takes for current antidepressants to work.

While ketamine itself probably won’t be used as an antidepressant because of its side effects, researchers said the new finding moves scientists considerably closer to understanding how to develop faster-acting antidepressant medications.

“In any other illness of depression’s magnitude, patients aren’t expected to just accept that their treatments won’t start helping them for weeks or months,” said Dr. Thomas Insel, NIMH director. “The value of our research on compounds like ketamine is that it tells us where to look for more precise targets for new kinds of medications that can close the gap.”

The study is reported online in the journal Biological Psychiatry.

Copyright 2007 by United Press International. All Rights Reserved.

The research, conducted by the National Institute of Mental Health, focused on how ketamine, when used experimentally for depression, relieves symptoms in hours instead of the weeks or months it takes for current antidepressants to work.

While ketamine itself probably won’t be used as an antidepressant because of its side effects, researchers said the new finding moves scientists considerably closer to understanding how to develop faster-acting antidepressant medications.

“In any other illness of depression’s magnitude, patients aren’t expected to just accept that their treatments won’t start helping them for weeks or months,” said Dr. Thomas Insel, NIMH director. “The value of our research on compounds like ketamine is that it tells us where to look for more precise targets for new kinds of medications that can close the gap.”

The study is reported online in the journal Biological Psychiatry.

Algorithm selects best cancer treatment

CHARLOTTESVILLE, Va., July 24 (UPI) — U.S. medical scientists have created an algorithm that can sort molecular information about a tumor, helping select the best drug treatment.

University of Virginia researchers, led by Dr. Dan Theodorescu and computational biologist Jae Lee, used a panel of 60 diverse human cancer cell lines from the National Cancer Institute to devise an algorithm designed to match the best potential treatments for a particular tumor in a specific patient.

“Even though this NCI cell set wasn’t an exhaustive encyclopedia of cancer cells, we found we could use the available data to draw conclusions about other cell types we were exploring,” said Theodorescu. “We believe we have found an effective way to personalize cancer therapy.”

In addition to predicting patient responses to therapy, the researchers said their algorithm can be used to discover effective compounds in any form of cancer.

The study, which involved scientists at GeneLogic Inc., appears in the early online edition of the Proceedings of the National Academy of Sciences.

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New method found to combat HIV

MINNEAPOLIS, Minn., July 24 (UPI) — U.S. medical researchers have developed a method of fighting the human immunodeficiency virus that might replace the drug cocktail approach.

Scientists at the University of Minnesota’s Center for Drug Design said their new approach combines the features of two antiviral agents into one drug, achieving the same effect as when two or more drugs are taken separately.

The scientists said the new concept — called Portmanteau Inhibitors –involves one drug that does the same thing as two independent drugs.

Besides remedying cost and toxicity problems, a Portmanteau Inhibitor is less likely to develop resistance from the virus because of its multi-faceted approach, said study leader Robert Vance, director of the center and a professor of medicinal chemistry. Most importantly, he said, the separate components of the drug do not interfere with each other while attacking HIV — the cause of AIDS.

The research appeared in the July 4 issue of the Journal of Medicinal Chemistry.

New color-changing technology created

SOUTHAMPTON, England, July 24 (UPI) — A team of British and German scientists has created a new type of flexible plastic film that allows objects to precisely change color.

The technology has many potential applications, said the scientists from the University of Southampton and the Kunststoff-Institute in Darmstadt, Germany. For example, a person could tell at a glance whether perishable food items in a refrigerator have spoiled, or whether a dollar bill is counterfeit simply by stretching it to see if it changes hue.

The researchers said their film combines the best of natural and manmade optical effects, essentially representing a new way for objects to precisely change their color depending upon various conditions.

Biovail shares sank to their lowest level since December on the news, reducing the market value of Canada’s largest publicly traded drug company by nearly $900-million in one day, with nearly 3.8 million shares traded on the Toronto Stock Exchange.

Analyst John Maletic at Scotia Capital Inc. said Biovail was hoping its new drug would counter some of the loss expected when its patent exclusivity expires on Wellbutrin XL, a time-release antidepressant that accounts for a substantial portion of its revenue.

Mississauga, Ont.-based Biovail was expected to launch its once-daily formulation of bupropion, a component to be used in a new anti-smoking drug and antidepressant, in the fourth quarter of 2007, but now that likely won’t happen until the fourth quarter of 2008, said Paradigm Capital Inc. analyst Claude Camire.
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And this delay will affect the amount of competition the drug faces when it’s eventually launched, he said.

“This is a drug that was well-suited to be sold in the next few months because the market landscape is changing. There will be more competition, there will be more generic products out there,” Mr. Camire said. “Drug patents expire, the competition comes in. So just by the sheer fact that it’s being delayed by one year, it will have a long-term impact [on the company].”

Mr. Camire described the drug as a “much improved version of what’s out there,” but said governments in Canada and the United States tend to prescribe generic drugs because they’re cheaper.

“The government will usually prescribe a generic drug first and even though you have to take the drug three or four times a day, or even if there’s a small side effect, they don’t really care, unfortunately. It’s all about money,” he said.

The FDA’s decision had nothing to do with the safety or the efficacy of the drug. It was a technical disagreement over the methodology used in Biovail’s pharmacokinetic studies, said Nelson Isabel, Biovail’s vice-president of investor relations and corporate communications.

“It was a disagreement between ourselves and the FDA on the design of the pharmacokinetic studies used to support our application. They wanted a different methodology used. We believe our methodology was appropriate,” Mr. Isabel, said, adding that it’s not uncommon for the pharmaceutical industry to experience such setbacks in the approval of new drugs.

“We’re going to request a meeting with the FDA, hopefully in the very near term, to discuss the non-approval letter and determine the next step to get the product approved as quickly as possible.”

There is no question the product will get approved eventually, but the company may have to conduct another study, he added.

“We’re not questioning the ultimate approval of the product. It’s a timing matter at this point, in our minds.”

He said the setback is “disappointing” but the program’s not dead.

“We’re still very active in getting the product approved and we want to get it approved as quickly as possible. We’re looking forward to meeting with the FDA promptly to move this forward,” Mr. Isabel said.

Paradigm Capital is planning to revise its 2008 estimate for Biovail downwards, and they are reviewing its price, Mr. Camire said.

It also appears yoga can lift levels of an antidepressant-like hormone, allopregnanolone, typically low in chronic sufferers.

But women’s health specialists are sceptical about the findings and say most women with PMS need more than stretching and meditation to get relief.

Indian researcher Ratna Sharma has told the World Congress of Neuroscience in Melbourne she has the first scientific evidence that yoga helps PMS.

“It is widely understood in India that yoga works (for PMS) but we’ve never shown it,” said Dr Sharma, a physiologist at the All India Institute of Medical Sciences, in New Delhi.

“The fact that it appears to influence symptoms and also change levels of an important hormone is very significant indeed.”

Researchers enlisted more than 40 women to practise yoga intensively, at least five times a week, for a month.

Half suffered the symptoms of PMS, typically psychological stress, depression, body aches and bloating in the week before a monthly period.

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Extensive questionnaires completed before and after the course showed yoga significantly reduced PMS symptoms in 64 per cent of sufferers.

“The women with the worst psychological symptoms benefited most,” Dr Sharma said.

Researchers also tested participants’ hormone levels before the yoga course and found sufferers had significantly lower levels of allopregnanolone, a biochemical known for its antidepressant qualities.

But after the trial, levels had risen, particularly in women whose depression had been alleviated.

Dr Sharma said the yogic activity somehow stimulated a hormonal change that in turn relieved symptoms but how it did this was not known.

Sue Reddish, medical director of the Jean Hailes Medical Centre for Women in Melbourne, said relaxation and exercise were known to help depression, which is closely linked to PMS.

“If yoga is enough to help a particular person that’s good but I doubt it’s enough for the majority of women with severe PMS,” Dr Reddish said.