Theresa Beckie, PhD, of the USF College of Nursing, compared the physical and psychosocial effects of a traditional cardiac rehabilitation to a program geared specifically for women.

ORLANDO, FL. (Nov. 17, 2009) — Depressive symptoms improved among women with coronary heart disease who participated in a motivationally-enhanced cardiac rehabilitation program exclusively for women, according to research presented at the American Heart Association’s Scientific Sessions 2009.

Depression often co-occurs with heart disease and is found more often in women with heart disease than in men. Depression also interferes with adherence to lifestyle modifications and the willingness to attend rehabilitation.

“Women often don’t have the motivation to attend cardiac rehab particularly if they’re depressed,” said Theresa Beckie, Ph.D., lead investigator and author of the study and professor at the University of South Florida’s College of Nursing in Tampa, FL. “Historically women have not been socialized to exercise and their attendance in cardiac rehabilitation programs has been consistently poor over the last several decades. This poor attendance may be partly due to mismatches in stages of readiness for behavior change with the health professional approaching from an action-oriented perspective and the women merely contemplating change --- this is destined to evoke resistance.”

Cardiac rehabilitation programs tailored to the needs of women and to their current level of readiness to change may improve adherence to such programs and potentially improve outcomes for women, she said.

The primary goals of the 5-year randomized clinical trial were to compare multiple physiological and psychosocial outcomes of women who participated in a 12-week stage-of-change matched, motivationally enhanced, gender-tailored cardiac rehabilitation program exclusively for women compared to women attending a 12-week traditional cardiac rehabilitation program comprised of education and exercise. Depressive symptoms of 225 women (average age 63) who completed this trial were examined after the interventions as well as after a 6-month follow-up period.

Women with cardiac disease have unique needs and confront different challenges than men in adopting healthy behaviors as they recover, Beckie says.

Participants completed the 20-item Center for Epidemiological Studies Depression Scale prior to beginning the intervention, one week after completing the intervention, and again six months later. The questionnaire asked them about how often in the past week they felt depressed, hopeful, lonely, happy and fearful.

Depression scores for the women participating in the traditional cardiac rehab dropped from 16.5 to 14.3 in 12 weeks, while scores in the augmented group dropped from 17.3 to 11.0 – “a significant decline compared to the traditional group,” said Beckie.

After a six-month follow-up, the traditional rehab group had an average score of 15.2 and those in the women-specific program had a mean score of 13. Beckie said “we found that improvements in depressive symptoms were sustained at the 6-month follow-up in the augmented group while those in traditional cardiac rehab were essentially unchanged. This intervention also led to significantly better attendance and completion rates than those in the traditional cardiac rehabilitation program.”

The intervention was guided by the transtheoretical model of behavior change and was delivered with motivational interviewing clinical methods. The motivationally-enhanced intervention began with an assessment of their stage of motivational readiness to change regarding three behaviors: healthy eating, physical activity, and stress management. The investigators then applied appropriate stage-matched strategies to promote the uptake of health behaviors.

“The stage-matched intervention used in conjunction with motivational interviewing applied the patient-centered principles of expressing empathy, rolling with resistance to change, respecting patient autonomy and supporting self-efficacy for change” Beckie said.

“We didn’t push them if they weren’t ready to make the changes,” Beckie said. “We have found that if some patients receive long lists of behaviors they are expected to change immediately — such as quitting smoking, eating healthier, exercising regularly — they are overwhelmed. Pushing such patients who are not ready can lead them to tune out or drop out. Instead, for these women, we acknowledged their ambivalence about change and gave them strategies to move toward being ready by reinforcing their own motivations for changing. It’s unrealistic to expect all patients to change their lifestyle all at once, right now in front of you.”

The positive impact of the women-centered program remained six months after the 12-week study ended.

The woman-centered program is a more individualized approach to rehabilitation.

“You can’t treat everyone the same when it comes to changing health behaviors,” she said.

Beckie hopes these results will lead to symptoms of depression being assessed more often in women suffering from heart disease and to more motivationally augmented, women-specific rehabilitation options. The participants may not be completely representative of the national population because they all had health insurance.

Beckie’s co-author is Jason Beckstead, PhD. The National Institute of Nursing Research funded the 5-year study.

- USF Health -

USF Health is dedicated to creating a model of health care based on understanding the full spectrum of health. It includes the University of South Florida’s colleges of medicine, nursing, and public health; the schools of biomedical sciences as well as physical therapy & rehabilitation sciences; and the USF Physicians Group. With more than $380.4 million in research grants and contracts last year, USF is one of the nation’s top 63 public research universities and one of 39 community-engaged, four-year public universities designated by the Carnegie Foundation for the Advancement of Teaching.

The USF arm of the NIH trials will be performed at Genesis, Tampa General Hospial and USF clinics.

Tampa, FL (Oct. 26, 2009) -- The University of South Florida is participating in two federal studies to see whether the H1N1 vaccine can safely elicit a protective immune response in pregnant women, as well as in children and young adults, all of whom are HIV-infected.

USF will be one of 35 sites and eight sub-sites in the United States and Puerto Rico participating in the two studies, which are sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), both part of the National Institutes of Health. Investigators plan to vaccinate about 130 HIV-infected women and 140 HIV-infected children and young adults around the country.

USF is participating in both studies as part of its role as a site of the International Maternal-Pediatric-Adolescent AIDS Clinical Trials Group (IMPAACT) network, a project of NIAID and NICHD that develops and implements multi-center HIV treatment and prevention research trials.

In the first study, on HIV-infected pregnant women, about 10 women are expected to be enrolled in the Tampa Bay area, said Dr. Karen L. Bruder, USF assistant professor of obstetrics and gynecology and the principal investigator for USF’s study site. Dr. Bruder also is medical director of the Genesis at HealthPark clinic of Tampa General Hospital.

The study is particularly important for this group of women because pregnant women already are at greater risk of suffering serious complications from the H1N1 virus, largely because their immune systems do not function at their normal levels. If a pregnant woman also is infected with HIV, her immune system is further compromised.

“She is already immuno-suppressed,” Dr. Bruder said.

Dr. Karen Bruder leads the USF study site testing whether the H1N1 vaccine protects HIV-infected pregnant women.

The study will look at how the vaccine affects the woman and her infant -- for instance, how many antibodies to the H1N1 influenza virus does the woman develop in response to the vaccine? Are those antibodies transferred to the fetus? After the baby is born, does it still have antibodies to the virus?

The study will also evaluate whether the vaccine affects the woman’s HIV viral load or the cells in the immune system that are often affected by HIV.

Women in the study will receive two doses of vaccine. The women’s response to the vaccine will be evaluated during pregnancy, at delivery, and at 3 and 6 months after delivery. The babies will be evaluated when they are 3 and 6 months old.

USF’s work in the study will be performed at Genesis, Tampa General and at USF clinics.
In the second study, at least four HIV-infected children or young adults will receive the H1N1 vaccine at the USF clinics, said Dr. Jorge Lujan-Zilbermann, associate professor of pediatrics and principal investigator for the USF site of the study.

This study will divide subjects into three age groups: ages 4 to 9, 10 to 17, and 18 to 24. As in the first study, the children and young adults will receive vaccine in two doses three weeks apart. Study subjects will be followed for seven months.

The study will examine how safe the vaccine is, how effectively it stimulates the immune system to make antibodies to the H1N1 influenza virus, and how long children and young adults maintain these antibodies in their blood after being vaccinated. The study will also look at other immune responses.

The vaccine all study subjects will receive contains inactivated virus, so it will not be possible for them to contract H1N1 influenza from the vaccine. Because of the increased vulnerability of HIV-infected pregnant women, children and youth, the trials will test whether doses of the licensed 2009 H1N1 influenza vaccine that are higher than doses being tested in other groups can safely elicit protective immune responses in these populations.

The IMPAACT sites participating in these studies will receive vaccine from Novartis Vaccines and Diagnostics of Cambridge, Mass, through the Office of the Assistant Secretary for Preparedness and Response for the U.S. Department of Health and Human Services.

For more information about NIH-sponsored clinical trials of H1N1 influenza vaccine in HIV-infected pregnant women, children and youth, see http://www3.niaid.nih.gov/news/newsreleases/2009/H1N1HIVTrials.htm and http://www3.niaid.nih.gov/news/QA/H1N1VacHIVChildYouthPregWomenqa.htm

- USF Health -

USF Health is dedicated to creating a model of health care based on understanding the full spectrum of health. It includes the University of South Florida’s colleges of medicine, nursing, and public health; the schools of biomedical sciences as well as physical therapy & rehabilitation sciences; and the USF Physicians Group. With more than $380.4 million in research grants and contracts last year, USF is one of the nation’s top 63 public research universities and one of 39 community-engaged, four-year public universities designated by the Carnegie Foundation for the Advancement of Teaching. For more information, visit www.health.usf.edu

- Story by Lisa Greene, USF Health Communications
- Photos by Eric Younghans, USF Health Communications

The USF Health Rothman Center for Neuropsychiatry in St. Petersburg is conducting a two-year federal trial testing the effectiveness of behavioral psychotherapy in treating anxiety among young adolescents with autism.

USF is one three sites for the $1-million study, sponsored by the National Institute of Child Health and Development (NICHD) through the American Recovery and Reinvestment Act. The other two sites are the University of California at Los Angeles and the University of Miami. The USF arm of the study will receive approximately $500,000.

USF's Eric Storch, PhD, is principal investigator for the multi-site behavioral therapy trial.

Autism spectrum disorders, collectively referred to as autism, cause pervasive impairment in thinking, feeling, language and the ability to relate to others and can range from a severe from (called autistic disorder) to a much milder form known as Asperger syndrome. Anxiety disorders affect as many as 80 percent of children and adolescents with autism spectrum disorders, triggering distress and impairment over and above that caused by an autism diagnosis alone, said Eric Storch, PhD, principal investigator for the multi-site trial and associate professor of pediatrics and psychiatry at USF Health.

“As yet, there are no tried-and-true methods for treating the anxiety that often accompanies autism,” Dr. Storch said. “Cognitive behavioral therapy has worked very well for typically developing kids with anxiety. The goal of this study is to adapt this therapy for use in early adolescents with autism and co-occurring anxiety.”

Cognitive behavioral therapy (CBT) involves exposing a patient to what they fear in controlled, graduated doses in an attempt to decrease their anxiety over time and prevent a compulsive or avoidance response. It has become a gold standard treatment for youngsters with anxiety disorders who do not have complicating conditions like autism or attention deficit hyperactivity disorder.

The researchers will first adapt a CBT protocol they have developed for younger children to meet the characteristics and clinical needs of early adolescents (ages 11 to 14) with autism. They will accomplish this by treating numerous youngsters and consulting with other autism experts. Then, the team will enroll 32 adolescents with autism in a randomized trial across the sites. The participants will receive either the newly developed CBT protocol or a modified relaxation training protocol (control group). Those who receive the control treatment will receive CBT afterwards.

“Considering the rising number of young adolescents diagnosed with autism, and the lack of proven treatment options for those suffering from anxiety,” Dr. Storch said, “our work developing a treatment protocol could substantially help address the mental health needs of early adolescents with autism.”

USF co-investigators for the NICHD study include Tanya Murphy, MD, professor and Rothman Endowed Chair of Developmental Pediatrics in the Departments of Pediatrics and Psychiatry; and Adam Lewin, PhD, and Jane Mutch, PhD, both assistant professors of pediatrics.

- Story by Anne DeLotto Baier, USF Health Communications

Recovery Act funds COPH study and pilot training program

A USF College of Public Health researcher has received a highly competitive National Institutes of Health grant to create and evaluate a web-based training program to help dentists and dental hygienists identify patients with eating disorders and refer them for treatment. Rita DeBate, PhD, associate professor in the Department of Community and Family Health, was awarded the two-year NIH Challenge Grant through the American Recovery and Reinvestment Act (ARRA). The ARRA funding is expected to be $985,517 over two years.

NIH AARA Challenge Grants were designed to spur new areas of research and trigger an influx of research dollars into communities across the nation starting in September 2009. With NIH receiving 20,000 challenge grant applications, competition was called “fierce.” While Florida universities received 177 awards through the ARRA, only a few were awarded in Florida.

Eating disorders, such as bulimia and anorexia nervosa, have potentially serious health consequences that can contribute to, or cause, death, according to the U.S. Center for Disease Control’s National Center for Health Statistics. Most people diagnosed with an eating disorder are under age 25, but deaths from eating disorders are highest among those between the ages of 25 and 64, NCHS statistics show.

Early identification, referral, and treatment significantly increase the likelihood of recovery, said Dr. DeBate. “Oral health providers play a fundamental role in the early detection, patient-specific oral treatment, and referral for care of eating disorders, because they are often the first health professionals to observe overt health effects. However, few dentists and dental hygienists are practicing this important clinical responsibility.”

Rita DeBate, PhD, received one of three highly competitive NIH ARRA Challenge Grants in Florida.

Over the two NIH-funded years, Dr. DeBate, the project’s principal investigator, and co-principal investigator Herbert Severson, PhD, senior research scientist at Oregon Research Institute, will customize their prototype web program, “Eating Disorders and Oral Health,” for use within dental and dental hygiene academic training programs. Adaptation of the prototype will be guided by input from dental and dental hygiene faculty and directors, an expert consultant panel, previous pilot data, and current e-learning methodology. Evaluation of the adapted web-based training program will involve 12 dental schools and dental hygiene programs across the country.

Damage to teeth, gums and oral tissue from disordered eating behaviors can begin as early as three months after excessive dieting or vomiting.

“The state of one’s oral health can be considered an early warning system for numerous health issues, including eating disorders,” Dr. DeBate said. “Consequently, oral health professionals can be among the first to observe the effects of eating disorders, but may not intervene for a variety of reasons. For instance, they may lack training and skill in identification of oral and physical symptoms of eating disorders, such as signs of malnutrition, dehydration and vomiting.”

Dr. DeBate’s previous research, which included focus groups with dentists and dental hygienists, revealed that they often felt uncomfortable approaching patients on sensitive topics such as an eating disorder.

“They realize that this is an important oral/systemic health issue, but also noted that they lacked confidence in patient approach, communication, and referral for treatment,” Dr. DeBate said. “In part, this program aims to improve skills in patient communication regarding this sensitive topic.”

Many dental health professionals also felt they could not start an oral treatment program with patients who, because of the secretive nature of their behavior, might be denying their eating disorder, she said. “Treatment can only begin when patients are ready for it. So assessing patient readiness to address disordered eating behaviors and secondary prevention are linked.”

Dr. DeBate and colleagues hope that the training program will increase dental professionals’ capacity to deliver eating disorder-specific secondary prevention and, ultimately, increase the rates of early treatment for people with eating disorders.

- Story by Randolph Fillmore, Florida Science Communications
- Photo by Eric Younghans, USF Health Communications

     Imagine two retirees, both in Florida, both with similar lifestyles and health conditions. The only difference: one lives in Miami, the other in Tampa.

      Chances are, the federal government spends nearly twice as much on the Miami retiree as the Tampa one.

      Those are among the findings of a project called the Dartmouth Atlas, an ongoing examination of differences in health care spending around the U.S. On Friday, Jonathan Skinner, senior author of the Dartmouth Atlas John Sloan Dickey Third Century Chair of Economics at Dartmouth College, discussed those differences at a talk presented by the USF College of Public Health.

     Health economist Jonathan Skinner, PhD, chats with Donna Petersen, ScD, MHS, dean of the College of Public Health

       The nation’s most expensive Medicare patients are in Miami, where Medicare spends $16,351 per enrollee each year. Compare that to Tampa, where spending is $8,911 per enrollee.

      Those cost differences mount up, Dr. Skinner said.

      “You start ending up with enough money for, if not a new Ferrari, at least a used Ferrari,” he joked.

      The cost differences are particularly puzzling when you look at health quality measures , Dr. Skinner said. For example, Medicare spends far less per enrollee in San Francisco than in Miami.

     “Yet by all measures,” he said, “San Francisco is at least as good as Miami.”

      Those differences have important policy implications, Dr. Skinner said – both for reining in Medicare’s spiraling costs and for health care reform. What if we could deliver the same quality of care across the country on a San Francisco budget instead of a Miami one?

      “Could we get closer to universal coverage?” he asked.

      Dartmouth Atlas researchers have tried to find non-medical ways to explain the cost disparities. But possible differences in patients in different cities don’t seem to explain the gaps, Dr. Skinner said. Researchers have adjusted for differences in age, sex, race and income without explaining the disparities.

      What does have an effect? In some places, what Dr. Skinner describes as “entrepreneurial surgeons” – doctors who are aggressive adovocates for a particular procedure – can affect costs. Cardiologists in Elyria, Ohio, for instance, attracted national publicity after Dartmouth Atlas research showed that residents there were getting angioplasties at four times the national average.

      Similarly, another factor that explains regional differences is the amount of money each region spends on health care during the last two years of life -- how chronically ill patients are treated and how often they’re hospitalized.  Small differences in how doctors make decisions about whether to send a patient to a hospital or a specialist can add up to big changes in spending.

- Story by Lisa Greene, photos by Eric Younghans, USF Health Communications

Some of the USF Health faculty awarded federal research stimulus funds.

Since this spring, USF Health faculty submitted 116 proposals for economic stimulus funding available through the American Recovery and Reinvestment Act (ARRA). The ARRA applicants gathered Oct. 6 in the USF Health Rotunda to celebrate the fruits of their collaborative efforts – 21 federal research awards totaling more than $4.2 million.

The stimulus grants help support a wide variety of projects, from College of Medicine professor Gary Litman’s studies of the evolutionary origins of genes of immunity to College of Public Health researcher Rita DeBate’s work to create and evaluate a prototype web-based training program that will help dentists and dental assistants identify patients with eating disorders. Maureen Groer, director of the College of Nursing’s Center for Women’s Health Research, will use the award to supplement research examining the influence of breast feeding on postpartum stress and immunity.

Dr. Phil Marty spoke about research on the rise at USF.

“This was an opportunity in which faculty and staff from both sides of campus came together and put in tremendous time and energy needed to get a lot of excellent research proposals out the door quickly,” said Phillip J. Marty, PhD, associate vice president for the USF Health Office of Research. “Our efforts were successful.”

Stephen Klasko, MD, MBA, vice president for USF Health and dean of the College of Medicine, also thanked all who collaborated to submit proposals under a time crunch. “I’m proud of our faculty and appreciate very much all the hard work by the USF Health Research Office and Sponsored Research staff,” he said. “Even the grants we did not get have raised some opportunities for us.”

ARRA funds were dispersed from various institutes and centers across the National Institutes of Health (NIH) by Sept. 30 with the goal of moving the economy and stimulating jobs through research.

Dr. Stephen Klasko thanked all applicants and awardees for their hard work.

The reception recognizing ARRA applicants and awardees was part of ResearchONE, a week of events, Oct. 5-9, highlighting USF’s vast research enterprise and showcasing cutting-edge projects by both the campus community and the Tampa Bay region.

ResearchONE this year came on the heels of USF being named in The Chronicle of Higher Education as the fastest-growing university in the nation for federal research expenditures between 2000 and 2007. Simply translated, that means that during those seven years, no other group of faculty had a faster rate of earning new federal sponsorship for the discovery and creation of knowledge.

Research staff from USF Health and USF Sponsored Research worked with faculty to help get ARRA proposals out the door within a tight timeframe.

USF also recently announced a new record in research funding, $380.4 million in 2008-09 -- a $20 million increase over the previous year. USF Health’s colleges of medicine, nursing and public health attracted more than $232-million in research awards, or 61-percent of USF’s total awards.

For a full list of USF's NIH stimulus grant recipients (as of Oct. 2, 2009) compiled by the U.S. Department of Health and Human Services, click here.

L to R: Thomas Unnasch, PhD; who received ARRA awards supplementing his research with onchocerciasis and Eastern equine encephalitis, chats with Boo Kwa, PhD, and Matt Rollie of the Department of Global Health.

- Story by Anne DeLotto Baier, USF Health Communications
- Photos by Gil Williams, Gil Williams Photography

Three College of Public Health faculty members have been recognized with 2009 Outstanding Research Achievement Awards -- John Adams, PhD, Professor, Global Health; Russell Kirby, PhD, Professor and Marrell Endowed Chair, Community and Family Health; and Hamisu Salihu, MD, PhD, Professor, Epidemiology. The awards are bestowed on faculty whose exceptional research was recognized with preeminent awards, grants or publications in top journals during the 2008 calendar year. The $1,000 awards were presented Oct. 9 at a luncheon sponsored by the USF Office of Research & Innovation.

Dr. John Adams was recognized for the publication of “Comparative Genomics of the Neglected Human Parasite Plasmodium vivax Illuminates Malaria Parasite Biology” in the journal Nature and two articles in Public Library of Science Pathogens (PLoS Path). A member of the USF College of Public Health’s Global Health Infectious Diseases Research team, he studies protein ligands that help malaria parasites bind to a person’s red blood cell wall. His team uses advanced analytic technologies to pursue effective vaccine and mosquito-based therapies to prevent malaria caused by P. vivax and P. falciparum, the most common types of malaria. Dr. Adams contributed to a major international research initiative comparing the genome of the malaria parasite P. vivax with other sequenced Plasmodium genomes. Comparing similarities and differences between parasites’ genomes can help determine genetic targets for new drugs and vaccine development. Dr. Adams oversees the Vector-Borne Pathogen Laboratory, or insectary, where researchers study the complex life cycle of the malaria parasite transmitted by mosquitoes.

Dr. Russell Kirby was recognized for receiving the Godfrey P. Oakley, Jr. Award by the National Birth Defects Prevention Network for his significant contributions to the field of birth defects and his senior leadership in several collaborative research projects undertaken by the network. Dr. Kirby is a doctorally-trained geographer with extensive training and experience in public health practice, academic medicine and academic public health. While his research interests in maternal and child health are quite broad, he focuses on population-based research in birth defects and developmental disabilities epidemiology and prevention, as well as on risk factors for adverse pregnancy outcomes. He recently co-authored the book Perinatal Epidemiology for Public Health Practice, and collaborates extensively with professionals from a variety of disciplines, including medicine, nursing, public health, economics, sociology and psychology. Dr. Kirby is president of the Society for Pediatric and Perinatal Epidemiologic Research and of the Association of Teachers of Maternal and Child Health.

Dr. Hamisu Salihu was recognized for publication of a novel theory called “event memory hypothesis,” which suggests a possible molecular memory-recall programming pattern in human gestation using epidemiological and molecular evidence. The groundbreaking theory suggests that when fetal death occurs the event is retained (memorized) as a program that is replayed in future pregnancies. In 2008 this theory was published in the journals Medical Hypotheses and Obstetrics & Gynecology, and may help to understand and prevent the causes of fetal death. Dr. Salihu, director of the Center for Research and Evaluation at the Chiles Center for Healthy Mothers and Babies at USF, is a leading researcher in the field of infant mortality. He is a key player in the Black Infant Health Practice Initiative – a statewide collaborative to address the racial gap in infant deaths in Florida and to recommend policy changes at the local and state levels. He has authored more than 100 journal articles; including recently published studies that shed new light on obesity’s role in the black-white gap in infant mortality.

- Story by Anne DeLotto Baier, USF Health Communications
- Photos by Eric Younghans, USF Health Communications

- Long research road delivers -

USF Health neuroscientist Doug Shytle, PhD (right), accepts the Excellence in Innovation Award from Paul Sanberg, PhD, DSc, associate vice president for research and innovation.

The University of South Florida’s 2009 “Excellence in Innovation” award was presented last week to R. Douglas Shytle, PhD, associate professor and research scientist in the USF Center of Excellence for Aging and Brain Repair and the USF Silver Child Development Center. The award recognizes Dr. Shytle’s translational research achievements in developing new intellectual property based on clinical research and novel pharmacological discoveries which have led to newly commercialized therapeutics.

His most recent success is with a new experimental antidepressant, known as TC-5214, which is covered by USF patents and licensed to Targacept, Inc., a clinical-stage biopharmaceutical company that develops neuronal nicotinic receptor therapeutics. Targacept recently announced the positive results on TC-5214 as an augmentation treatment (add-on treatment) in a large clinical trial of adult patients with treatment resistant major depressive disorder.

While the Innovation Award encourages USF faculty to “think out of the professorial box,” for Dr. Shytle the road leading “out of the box” and to the success of TC-5214 was long, winding, and strewn with professional and emotional ups and downs as well as moments both serendipitous and Eureka.

“TC-5214 is a unique form of an old Merck drug called ‘mecamylamine,’ once used to treat severe hypertension in the 1950s,” explains Dr. Shytle. “Because later research suggested that mecamylamine interacted with brain nicotine receptors, we thought it might have a variety of therapeutic effects similar to nicotine, but without the side effects and addiction.”

Building on earlier USF clinical research using transdermal nicotine to treat patients with Tourette’s syndrome (characterized by body movements (tics) and vocalizations), Dr. Shytle, worked closely with USF professors, Archie A. Silver, MD, David Sheehan, MD, and Paul Sanberg, PhD, DSc, to investigate the effects of mecamylamine in Tourette's patients to see if it could help control their symptoms, as observed with nicotine.

“After carefully designing and conducting a large clinical trial in children with Tourette’s syndrome in 1999, we were shocked and disappointed to find that the drug had no effect on the tic symptoms,” recalls Shytle. “After reading several reports about how many antidepressants appeared to be interacting with nicotine receptors the same way as mecamylamine did, we decided to go back and take a second look at the data from our clinical trial. And there it was, like finding a gold nugget buried under the sand, clear evidence for an antidepressant effect of mecamylamine, but not for the placebo, in those Tourette’s subjects who had depressive symptoms.”

Based on those clinical findings, the researchers published a hypothesis paper in the prestigious journal, Molecular Psychiatry, proposing that nicotine receptor blockade might represent a novel pharmacological target for achieving therapeutic antidepressant properties. That hypothesis has now been supported by three clinical trials with mecamylamine, one by a group at Yale and two larger studies conducted by Targacept. The latest trial was conducted using TC-5214, a unique form of mecamylamine, predicted by the USF patents to be more effective with fewer side effects when compared to the older parent drug.

The results of this study are expected to have profound implications for the future treatment of major depression, making TC-5214’s impact on the market potentially huge.

“The Excellence in Innovation Award that Dr. Shytle received this year is a testament to the kind of creative translational research that attracts excellent industry partners, like Targacept, who have the vision and technical expertise to take our intellectual property to the next level of commercial development”, said Dr. Sanberg, associate vice president for research and innovation, who presented the award to Dr. Shytle Oct. 5 at USF's ResearchOne celebration. (Dr. Shytle was one of three USF faculty members who received the innovation award this year; the other two awardees were from Chemistry and Computer Science).

The USF license agreement with Targacept includes a percentage of sublicense and milestone payments as well as a royalty stream through 2021 should the drug achieve FDA approval.

"I am simply delighted that Dr. Shytle received this award for finding a 'diamond in the desert' after years of work," says Dr. Sheehan.

Dr. Shytle is an inventor on several USF patents in addition to four on mecamylamine and related compounds.

Story by Randolph Fillmore, Florida Science Communications
Photo by Joseph Gamble, USF Communications & Marketing

The antibiotic minocycline may revolutionize the treatment of strokes. A new study, published online Oct. 6 in the open access journal BMC Neuroscience, describes the safety and therapeutic effectiveness of the drug in animal models.

Cesar V. Borlongan, PhD, a neuroscientist at the University of South Florida Center for Aging and Brain Repair, worked with a team of researchers from Medical College of Georgia to test the treatment in laboratory experiments.

“To date, the thrombolytic agent tPA is the only effective drug for acute ischemic stroke; however, only about 2 percent of ischemic stroke patients benefit from this treatment due to its limited therapeutic window,” Borlongan said. “There is a desperate need to develop additional neuroprotective strategies. This research is an important step in rectifying the treatment issues, presenting a new, more effective treatment for stroke patients.”

USF neuroscientist Cesar Borlongan, PhD, was the study's principal investigator.

Stroke is the third leading cause of death in the United States, and currently accounts for almost 10 percent of deaths worldwide, claiming more lives than HIV/AIDS. During a stroke, a clot prevents blood flow to parts of the brain, which can have wide ranging short-term and long-term implications.

This study recorded the effect of intravenous minocycline in both isolated nerve cells and animal models after a stroke had been experimentally induced. At low doses the antibiotic was found to have a neuroprotective effect by rapidly reducing neuronal cell death (apoptosis) and alleviating behavioral deficits caused by stroke. The researchers also found that this neuroprotection was dose-dependent, underscoring the importance of the dose delivered for a safe outcome. While low-dose minocycline inhibited neuronal cell death at the early, or acute, phase of a stroke, a higher dose aggravated the brain injury from stroke.

An ongoing phase 1 clinical study funded by the National Institutes of Health is exploring the use of intravenous minocycline to treat acute ischemic stroke.

“The safety and therapeutic efficacy of low dose minocycline and its robust neuroprotective effects during acute ischemic stroke make it an appealing drug candidate for stroke therapy,” Dr. Borlongan said.

     The USF College of Medicine is expanding  its ability to study tiny things called “nanoparticles,”  thanks to a $1.39 million federal grant to its USF Nanomedicine Research Center.

     The grant comes from the National Institutes of Health and is funded through the American Recovery and Reinvestment Act.

     The Nanomedicine Research Center’s  mission is to research areas of nanomedicine that ultimately could treat heart, lung and blood disorders. Research focuses closely on drug delivery and detection of disease cells, as well as integrating nanomedicine to tissue engineering and cell technologies.

     Nanomedicine uses extraordinarily tiny materials – too small to be seen with the naked eye -- to develop innovative ways to detect and treat disease. For example, a researcher might look for ways to use particles small enough to deliver drugs or therapeutic genes inside a tumor cell.

     Shyam Mohapatra, PhD, director of the Nanomedicine Research Center, is doing research using nanoparticles made of chitosan, a substance found in  shrimps, prawns and shellfish. His laboratory has shown that chitosan particles can safely and effectively deliver therapeutic genes into cells lining the lungs and effectively treat lung diseases such as  asthma or lung cancers in mice.

     Another project in the Nanomedicine Research Center has federal funding from the Office of Naval Research to develop ways to turn stem cells into blood cells.

     “In the battlefield, there’s never enough blood,” said Dr. Mohapatra. “This technology is very futuristic. It could lead to the development of devices that would be like a wristwatch with stem cells in it that could travel into your bloodstream and become blood cells” in case of injury.

     This grant, for a two-year period, will enable the Nanomedicine Center to hire one new faculty member and three support staff. Dr. Mohapatra, who also is the Mabel & Ellsworth Simmons Professor of Allergy & Immunology, expects the new personnel to add to the center’s ability to conduct interdisciplinary research between faculty in Medicine with those in basic sciences such as chemistry, physics, and biology and in engineering.

     -- Story by Lisa Greene, USF Health Communications