ANTI DEPRESSANT DRUG BLOG

Scientists speed antidepressant action

July 26, 2007

U.S. scientists have moved closer to producing faster acting antidepressants than exist today by using the experimental medication ketamine.

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.

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UPI NewsTrack Health and Science News

July 25, 2007

U.S. scientists have moved closer to producing faster acting antidepressants than exist today by using the experimental medication ketamine.

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.

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Biovail stock sinks after FDA rejects drug component

July 21, 2007

lost about one-fifth of its value yesterday after the drug manufacturer said it has failed to win approval from the U.S. Food and Drug Administration for a component of a new antidepressant.

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.

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Yoga poses a solution

July 17, 2007

SCIENTISTS have found the first proof that yoga can ease the pain of pre-menstrual tension.
Tests on women with the pre-period syndrome have found the ancient Indian art form can relieve their psychological and physical symptoms.

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.

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Two Large Studies Show Decline In Suicide Attempts With Antidepressant Treatment

July 11, 2007

Patients with depression treated in two independent health care systems experienced overall drops in suicide attempts between the month prior to starting treatment with antidepressant medications and the month after treatment began.

The findings are based on records from a large prepaid health plan and from Veterans Health Administration databases, reflecting the clinical care of more than 330,000 patients. These two studies are reported in the July issue of the American Journal of Psychiatry (AJP), the official journal of the American Psychiatric Association.

The first study, “Suicide Attempts Among Patients Starting Depression Treatment with Medications or Psychotherapy,” is presented by Gregory Simon, M.D., M.P.H., and James Savarino, Ph.D., of Group Health Cooperative-a mixed-model prepaid health plan with approximately 500,000 members in Washington State and Idaho.

Among the 109,256 members treated for depression between 1996 and 2005, suicide attempts decreased during the first month of treatment and diminished further in subsequent months. This progressive decline occurred for both patients taking medication and those receiving psychotherapy. About 60 percent of the treatment episodes began with antidepressant prescriptions and about 40 percent began with psychotherapy visits.

The second study, involving veterans, is described in “The Relationship Between Antidepressants and Suicide: Results of Analysis of the Veterans Health Administration Datasets,” by Robert Gibbons, Ph.D., Kwan Hur, Ph.D., J. John Mann, M.D., and colleagues at the University of Illinois at Chicago and the New York State Psychiatric Institute. The findings are based on 226,866 veterans diagnosed with depression during 2003-2004. The analysis, in addition to showing a decrease in suicide attempts once treatment began, also revealed a lower rate of suicide attempts in depressed veterans who took antidepressants compared to those who did not.

Selective serotonin reuptake inhibitors (SSRIs) were the most commonly prescribed antidepressants, and the rate of suicide attempts for patients taking SSRIs fell from 221 per 100,000 patients before treatment, to 123 per 100,000 after treatment began. The rate also fell after the beginning of treatment with medications known as non-serotonergic and tricyclic antidepressants.

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The positive overall outcomes in the two studies were shared by the youngest patients. The adolescents and young adults studied by Simon and Savarino made approximately twice as many suicide attempts as the total group, but they showed a similar decline after beginning treatment.

Gibbons et al. found that all age groups, including 18 to 25 year olds, experienced both a decline in suicide attempts with treatment and a lower incidence among depressed veterans receiving SSRIs, compared to those receiving no antidepressant treatment.

The authors point out that large-scale studies do not exclude the possibility that depression treatment may precipitate suicidal thinking or behavior in vulnerable individuals.

The findings are reviewed in an editorial by David Brent, M.D., of the University of Pittsburgh.

AJP Editor in Chief Robert Freedman, M.D., stated “These studies of treatment in actual clinical practice find a decrease in suicide attempts after treatment, regardless of whether the treatment is psychotherapy or drug therapy. Patients and their doctors are concerned because of the FDA’s black-box warning that antidepressants can cause suicide attempts. The studies in this issue provide more evidence that this side effect is rare, compared to the overall decrease in suicide attempts that occurs when treatment is initiated. Furthermore, suicide attempts in the first month of treatment occur regardless of whether the treatment is psychotherapy or drug therapy, which suggests that these attempts are part of the natural evolution of symptoms in depression itself.”

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Antidepressant drug type affects bones, study shows

July 9, 2007

Popular antidepressant drugs such as Paxil and Zoloft seem to make users’ bones more porous, perhaps raising the risk of a broken hip or spine fracture, two new studies show.

The research, published in the current Archives of Internal Medicine, looked at thousands of older men and women, including many Portland-area residents studied at Oregon Health & Science University. Tests showed hip and lower spine bones were notably less dense in the subjects that use a kind of antidepressant called a selective serotonin reuptake inhibitor, or SSRI, than in people who used other antidepressants or no depression drugs.

The studies did not count bone fractures, a major cause of sickness and death in the elderly, but bone loss is considered a warning sign that fractures are more likely. The amount of bone lost with SSRI use looks similar to the amount lost by users of certain steroids, drugs that have been linked to osteoporosis and more fractures.

“The magnitude of the bone loss is important” with SSRIs, said Dr. Elizabeth Haney, an OHSU scientist who worked on both papers. “We were surprised by that.”

Doctors say the findings are not a reason to stop using SSRIs, especially if you already take them.

“These drugs have been quite helpful in the treatment of depression,” said Dr. Thomas Dodson, president of the Oregon Psychiatric Association. “We are really concerned that people not overreact and come off their medication” before talking the issue over with their doctor.

But doctors and patients should be aware of the risks SSRIs bring. For instance, older people may need bone-density tests if they use SSRIs for more than several months, said Dr. Kenneth Saag, a University of Alabama at Birmingham bone and joint specialist who did not work on the studies. Fracture-prone people taking SSRIs might also consider building their bones through exercise, taking calcium and vitamin D or asking a doctor about bone-strengthening drugs.

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Antidepressants are the most-prescribed drugs in the United States, according to IMS Health, with 227.3 million prescriptions dispensed in 2006: enough to give every adult in the country a bottle. More than 60 percent of those prescriptions are for SSRIs.

The bone findings add to a growing list of side effects linked to SSRIs. Other studies indicate the pills might increase the risk of suicidal thoughts, especially in children, and may increase the risk for some birth defects if pregnant women take them — both ideas still debated by doctors and scientists. The drugs also have some more common and less potentially serious side effects including weight changes and sexual problems.

Still, SSRIs are considered safer than older depression drugs, especially tricyclic antidepressants such as Elavil. So SSRIs “are still the medication class that are preferred” for depression, Saag said.

Scientists have looked more closely at bones and SSRIs after OHSU’s Dr. Michael Bliziotes published a 2001 paper showing that proteins in bone cells interact with serotonin, a body chemical that also affects mood. When scientists gave mice SSRIs, they formed bone more slowly. In January, a Canadian study showed adults older than 50 who used SSRIs were twice as likely as others to break a bone. With the two new studies, “there is a mounting body of evidence to suggest a relationship” between bone loss and SSRIs, Saag said.

But the case is not proved, Haney said. No one knows just what serotonin does to bone cells. And depression itself seems to make people more likely to break bones. That could be because depression affects the bones directly or perhaps because depressed people often lose weight and get less exercise. Scientists aren’t sure.

“Patients receiving SSRIs are likely different in a number of ways from those who do not take them — in terms of nutrition, exercise, etc.,” said Oregon Osteoporosis Center Director Dr. Michael McClung, who was not connected to the studies. “Whether SSRIs cause the difference in bone mineral density or whether something else (like the severity of depression) results in both bone loss and in the choice of SSRI as the antidepressant cannot be ruled out.”

Haney said bone changes during SSRI need to be tracked more closely to prove the link. She also hopes to look again at the older people she studied, to check fracture rates and SSRI use. Many factors besides bone density can contribute to fractures, including bone shape, exercise, strength and good balance.

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Antidepressant Warnings Associated With Decreased Prescription Rates Among Tennessee Children

July 5, 2007

Antidepressant medications are frequently used to treat depression among children and teens, but in 2003 data emerged regarding an increased risk of suicidal thinking and behavior among young patients taking these drugs, according to background information in the article. “In December 2003, the Committee on Safety of Medicines [the U.K. drug regulatory agency] declared the risk-benefit profile of all selective serotonin reuptake inhibitor (SSRI) antidepressants (as well as venlafaxine hydrochloride and mirtazapine), with the exception of fluoxetine, to be unfavorable for the treatment of major depressive disorders in children and adolescents,” the authors write. “Shortly thereafter in 2004, the Food and Drug Administration convened a Psychopharmacology Advisory Committee meeting in February, issued a public health advisory in March, and in October required black box warning labels for all antidepressants (including fluoxetine) highlighting the potential increase in suicidal thinking and behavior in children and adolescents. The warning recommended more intense therapeutic monitoring to mitigate these risks but did not suggest avoiding the pediatric use of antidepressants.”

Benji T. Kurian, M.D., M.P.H., and colleagues at Vanderbilt University School of Medicine, Nashville, Tenn., examined monthly antidepressant prescription data among patients age 2 to 17 years covered by the TennCare expanded Medicare program. “The study included the 45 months from Jan. 1, 2002, through Sept. 30, 2005, 12 months following the FDA black box warning,” the authors write. “The study months were divided into two periods. The period before the regulatory warnings included the 24 months from Jan. 1, 2002, through Dec. 31, 2003, and that after the regulatory warnings included the 21 months from Jan. 1, 2004, through Sept. 30, 2005.” An average of 405,000 children and teens qualified for the study each month.

During the period before the regulatory warnings, there was little change from month to month in the rate of new antidepressant prescriptions, with an average of 23 per 10,000 patients. By the end of the study–a total of 21 months after the U.K. warnings–this proportion had decreased by 33 percent to an average of 15 per 10,000 per month.

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The decrease was most pronounced for SSRIs (except for fluoxetine) and another type of antidepressant linked to suicidal thoughts and behaviors, selective norepinephrine reuptake inhibitors. New users of fluoxetine, the only antidepressant approved by the FDA for the treatment of depression in children and adolescents, increased by 60 percent. “However, there was no evidence of an increase in discontinuations of therapy with antidepressant or other psychotropic drugs, which suggests that the primary effect of the warnings was to alter the decision to treat a newly presenting patient,” the authors write.

Previous studies have shown that the use of antidepressants among TennCare patients is similar to that of children and adolescents in the entire United States, suggesting that a similar decrease may have occurred in other populations. Because there is so much uncertainly regarding the pediatric use of antidepressants, the implications of these changes are unclear, the authors note. “Thus, while it is now evident that regulatory interventions can alter patterns of practice, whether this is desirable is uncertain,” they conclude. “There is an urgent need for better data on the efficacy and safety of antidepressants to guide pediatric practice.”

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Antidepressants Not Big Risk for Defects

July 2, 2007

Newborns face little risk of birth defects from antidepressants taken by many women early in pregnancy, say the reassuring findings of the two biggest studies of this controversial link.

The research focuses on the class of drugs chosen most often for depression and anxiety, including the brands Prozac, Paxil and Zoloft.

Paxil carries a warning of possible heart defects in newborns, and experts don’t expect the new research to change that. However, they find the new studies comforting for women struggling with depression.

The possibility of birth defects from antidepressants has put doctors and patients in a tricky quandary. Birth defects obviously hurt newborns, but depressed mothers who can’t give proper care also endanger their babies.

Confusing matters, researchers have wondered if the concern about birth defects should extend beyond Paxil to this entire class of drugs, known as selective serotonin-reuptake inhibitors, or SSRIs. The two latest studies, appearing Thursday in The New England Journal of Medicine, relieve some of that worry, say birth specialists.

“Yeah, there’s a risk, but the risk overall is probably pretty small,” said Dr. Susan Ramin, obstetrics chairman at the University of Texas Medical School in Houston, who was familiar with the findings.

The two studies , one from the federal Centers for Disease Control and the other from Boston University , use more cases of birth defects than previous research to consider links between the abnormalities and SSRIs. The Boston University study was funded partly by the National Institutes of Health and Paxil maker GlaxoSmithKline PLC.

Together, the two studies looked at 19,471 newborns with birth defects and 9,952 without them. Then they considered what SSRIs the mothers in both groups took during the first three months of pregnancy and mapped the patterns of birth defects.

Neither study was able to tie SSRIs as a group to either heart defects or most other defects. That reassurance is especially welcome because depressed women fret even more than other mothers about the health of their newborns, said Dr. Stephan Quentzel, a psychiatrist who treats pregnant women at Beth Israel Medical Center in New York City.

Also, a mother’s untreated depression can lead to poor care or turmoil at home, a weaker maternal bond, and other problems for a newborn. “The fetus and the newborn are almost always worse off if the mom is depressed than if … exposed to the vast majority of antidepressants,” Quentzel said.

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However, doctors and mothers have been very wary about medications and birth defects since Europe’s thalidomide scandal of deformed babies in the 1960s. Defects from all causes are expected in about 3 percent of births, enough to make many mothers nervous.

The concern about SSRIs grew out of GlaxoSmithKline’s own alert in 2005 about possible heart defects in newborns whose mothers took Paxil early in pregnancy. The U.S. Food and Drug Administration added its own warning. Last year, a separate study linked SSRIs taken late in pregnancy to a lung disorder in newborns.

The latest studies do not consider that disorder, known as persistent pulmonary hypertension. But they suggest that the risk of other defects from an SSRI , even if confirmed , would add only a fraction of 1 percent to the overall danger, researchers said.

Paxil did appear to triple the risk of a defect in blood flow from the heart, both studies found. But that additional danger would still be modest, experts said.

The studies further hinted at possible ties between other SSRIs and a handful of other defects, but researchers said the numbers of newborns with specific defects were too small to draw strong conclusions.

“Based on these studies, it’s correct to say: no major risk,” said Carol Louik, a public health expert who led the Boston study. “I wouldn’t say, ‘No risk.’”

Researchers said women should talk over the potential risks and benefits with their doctors, preferably before pregnancy.

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