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FRIDAY Dec. 7, 2012 — An experimental antidepressant that targets the brain in a different way appears to both act fast and last long, researchers say.
The new drug — called GLYX-13 — is so far given in an intravenous form and was recently tested in patients who had not responded to other antidepressants. It began its work within hours and a single dose lasted about a week, Northwestern University researchers reported.
“We saw a robust, rapid-acting, long-lasting effect,” said lead researcher Joseph Moskal, a research professor of biomedical engineering at Northwestern’s McCormick School of Engineering and Applied Science and director of the school’s Falk Center for Molecular Therapeutics. “In addition, we have shown little or no side effects with our compound.”
One expert said the drug might prove a valuable tool against depression.
“It sounds like an exciting development,” Dr. Bryan Bruno, acting chair of psychiatry at Lenox Hill Hospital in New York City said. If it were a pill, the drug could change treatment for many patients, he added. “Because it’s so quick it would be a huge advantage over our current medications all of which take six to eight weeks for the full effect and at least three to four weeks to start working for most people,” Bruno said.
Currently, the most popular drugs to treat depression are called selective serotonin reuptake inhibitors, or SSRIs. These include Prozac, Paxil, Zoloft and Lexapro. They work by improving levels of the hormone serotonin, which may be too low in people suffering from depression.
Although SSRIs are effective in many people, not all respond to the same drugs and some people don’t respond well.
GLYX-13, the new drug, is still being studied and it isn’t projected to be available before some time in 2016, Moskal said. Many unknowns remain about the drug, including its long-term effects, whether some people won’t respond to it and the effects of stopping its use.
Moskal, however, said he is confident that this drug will be a breakthrough in treating depression. Given the results so far, he said, people won’t need to take the drug every day, only once a week or less.
The GLYX-13 study is a phase 2 trial, which evaluates a drug’s effectiveness while continuing to assess its safety.
The results were presented Thursday at the American College of Neuropsychopharmacology annual meeting in Hollywood, Fla. Findings from the team’s animal research that led to the new method appeared online Dec. 3 in the journal Neuropsychopharmacology.
Moskal is the founder and chief scientific officer of the biotechnology firm Naurex Inc., which conducted the study. Northwestern University has licensed the intellectual property rights to certain therapeutics developed by Moskal to Naurex, according to a Northwestern news release.
The study received funding from the U.S. National Institutes of Health among others.
GLYX-13 targets parts of the brain linked to learning and memory. An advantage is that the drug doesn’t have the side effects of other drugs that target these same areas, such as hallucinations and schizophrenia-like symptoms, the researchers noted.
Moskal’s team developed a new way to target the brain’s NMDA (N-methyl-D-aspartate) receptor to achieve these results. The clinical trial included about 120 patients, Moskal said. Patients were either given the drug or an inactive placebo.
Antidepressant effects of the drug were seen within 24 hours and lasted an average of seven days. The effect of the drug was substantially better than seen with other antidepressants, the researchers found. The drug was so well received by patients that many who were in the trial have called asking to be in any further trials, Moskal said.
A new trial that makes use of the drug in pill form is slated to get under way next year, Moskal noted.
Because the drug targets these areas of the brain it might also help people with other problems such as schizophrenia, bipolar disorder, anxiety and Alzheimer’s disease, the researchers suggested.
For his part, Bruno cautioned that the long-term effects of the drug need to be studied before it can be used regularly in clinical practice.
Findings presented at medical meetings are typically considered preliminary until published in a peer-reviewed journal.
To learn more about depression, visit the U.S. National Institute of Mental Health.
Posted: December 2012
But Shot May Slightly Increase Risk for Guillian-Barre Syndrome in People 6 Months or Older
Infants born in Denmark whose moms got the H1N1 shot were no more likely to have major birth defects or to be born too early than infants whose moms did not get the vaccine during their pregnancies.
But a second, related study found that Canadians aged 6 months or older who received the H1N1 vaccine were at a slightly higher risk for developing Guillain-Barre syndrome during the two months following the shot.
Guillain-Barre syndrome is a nervous system disorder. It can causes muscle weakness, loss of reflexes, and numbness or tingling in the arms, legs, face, and other parts of the body. Most people recover without any lasting damage. In severe cases, however, GBS can cause paralysis and death.
According to the study, about two people developed GBS for every 1 million who received the vaccine.
The swine flu vaccine of 1976 was also linked to an increased risk of GBS, with one case of GBS per 100,000 people receiving the vaccine.
The flu itself increases risk of GBS as well.
H1N1 Shot Not Linked to Major Birth Defects, Preterm Birth
In the Danish study, researchers analyzed rates of major birth defects, preterm birth, and restricted growth in the uterus for infants in Denmark delivered between Nov. 2, 2009, and Sept. 30, 2010. Of 53,432 infants, 13.1% were exposed to the vaccine during pregnancy.
Infants whose mothers received the vaccine were not at any greater risk for any of these outcomes. This was true regardless of which trimester in pregnancy their moms received the shot, but fewer women got vaccinated in the first trimester.
“We conclude that H1N1-vaccinated pregnancies are not at increased risk of these adverse events,” says study author Anders Hviid, an epidemiologist at Statens Serum Institut in Copenhagen, Denmark. “Our study contributes to the information available on the safety of influenza vaccination in pregnancy, [but] it is by no means a complete evaluation of vaccination in pregnancy.”
During the H1N1 flu pandemic of 2009, pregnant women were urged to get vaccinated against this new swine flu strain with an all-new shot. An estimated 2.4 million women were vaccinated against the H1N1 flu during pregnancy in the United States alone, according to information in the new study.
The H1N1 vaccine in the new studies contained an adjuvant, or added chemical, to increase the body’s immune response to the vaccine. Adjuvants were not given in the U.S. Neither the U.S. pandemic H1N1 vaccine nor the U.S. seasonal flu vaccines contain adjuvants.
But that doesn’t mean the findings are irrelevant, says Mark C. Steinhoff, MD. He is the director of the Children’s Global Health Center at Cincinnati Children’s Hospital Medical Center. Steinhoff co-wrote an editorial accompanying the two new studies.
“In the event of a future pandemic, we will know that this adjuvant is safe,” he says.
Oliver Stone stopped by Late Night with Jimmy Fallon Thursday night to discuss his new film Savages (in theaters July 6).
During the segment, Fallon pulled out the August 2012 issue of HIGH TIMES and congratulated Mr. Stone for appearing on the cover of the mag (the iconic film director helped create an iconic cover shot, clad in a tuxedo and partially concealed by smoke from a joint).
Stone responded by saying, "I love that magazine and they’ve been doing …More
Nintendo made headlines last week when it announced something many felt it should have had in place years ago: the Nintendo Network. The details remain sketchy at best and, like with details on the Wii U, it is likely we’ll be waiting until E3 in June before we’ve given a better idea of how the Network will actually come together. What little president Satoru Iwata did have to share about it was encouraging, and the same could be said for a lot of what Nintendo at least claims to be doing as it works to put this current disastrous financial year behind it.
Following Friday’s investors briefing, a Q&A session was conducted where Iwata and company provided many unspecific, but nonetheless promising answers about how the company plans to avoid suffering another money-losing year.