The PRI Bulletin Issue Vol. 20, No.1
EYE ON IT What’s New at PRI? Memory Loss Concerns? ...For You or a Loved One? PRI has a wide array of studies aimed at potentially helping people with mild-tosevere memory loss, including studies specifically for the following, now enrolling at all three locations!
MILD COGNITIVE IMPAIRMENT? a.k.a. Prodromal (Pre-) Alzheimer’s Disease? This unique and very important project, for persons between 45 and 90 years of age, who have mild memory problems and do not have Alzheimer’s disease, is being conducted in the U.S., Canada, Sweden, Finland, Denmark and The Netherlands. PRI is very proud to have been one of the U.S. sites selected for participation in this program; moreover, the potential benefits for program participants are remarkable. Please call the PRI office nearest you, for your personal and confidential consultation/evaluation for possible inclusion in the landmark study! Your participation may not only prove to be beneficial to you, it may prove beneficial to millions of other people as well!
MILD-TO MODERATE ALZHEIMER’S DISEASE? Currently Taking Aricept®? There is “no question” that the absolute earliest possible diagnosis and treatment of Mild-toModerate Alzheimer’s disease is the most beneficial course of action for patients and their loved ones! Our new study enables patients to receive the benefits of the most widely prescribed anti-Alzheimer’s medication (Aricept®), plus (also receive) the potential benefits of a novel research medicine that has now reached Phase-III in its development stage.
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? Fall/Winter 2009
Bipolar Disorder:
Coping With Depression
Definitions, Descriptions and Options!
by: Elsa Cynthia Cabrera, M.D.
by: Nader Oskooilar, M.D., Ph.D. Medical Director
Depression can take many faces: It can present with not only a sad or depressed mood, but also with irritability, isolation, guilt, poor motivation and alterations in sleep. It can also lead to suicidal thinking and increased use of alcohol or drugs in an attempt of self-treatment.
Bipolar disorder, or manic-depressive illness, is a brain disorder which causes significant and often disturbing mood swings. They are different than the mood swings that everybody might go through and they can frequently lead to personal pain and suffering, as well as impairment in one’s social, interpersonal, and professional life. Bipolar disorder, like most psychiatric disorders, can be considered a continuum, where numerous sub-types of the disorder, with different intensities and durations, can be visualized. Depressive episodes can range from mild to severe; while the upswing of the mood may be significant (mania in Bipolar I) or moderate (hypomania in Bipolar II or in cyclothymia). Also, there can be what we sometimes categorize as “mixed episodes” (simultaneous mixtures of depressive and manic/hypomanic symptoms). Additionally, the mood swings can be protracted, rapid, or ultra-rapid. Psychotic symptoms such as delusions may also accompany the episodes, especially in mania and severe cases of depression. Common depressive symptoms of bipolar disorder include sadness, crying spells, severe anxiety, hopelessness, lack of motivation, loss of libido, poor sleep, fatigue, diminished concentration, difficulty making decisions, and disrupted appetite. Manic symptoms consist of increased energy, a decreased need for sleep, unusual hopefulnessto-grandiosity, a racing mind, impulsive decisions, euphoric mood, poor judgment, agitation, and unrealistic plans to delusional thinking. In hypomania, manic symptoms are less severe and the person usually does not require hospitalization. Accurate and timely diagnosis of bipolar disorder is of utmost significance. Unfortunately, it is often several years, from the first episode of the illness, before the correct diagnosis is made. This is due to Con’t on Page 2
Current research shows that depression is a true chemical imbalance, involving substances in the brain called neurotransmitters such as: serotonin, norepinephrine and dopamine. Con’t on Page 2
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What’s Inside
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Memory Loss and Alzheimer’s Disease: What you should know • The Professionals at PRI • Eye On It: What’s New at PRI? • Are You A Caregiver...Who Can Use A Little Relief?
Did You Know? Health Notes
It’s a fact: Memory Loss and Alzheimer’s Disease: What You Should Know by: My-Linh Tong, R.N., M.S.N., N.P.
It can occasionally happen to everyone. You’re not able to find your car keys or glasses. You’re at the grocery store but your list is at home. You forget the name of your neighbor or of people you rarely see. Alzheimer’s disease may start with slight memory loss, but, eventually progresses to irreversible impairment. Recognizing the normal changes, knowing what Alzheimer’s disease is, and knowing what to do are important in understanding memory loss and Alzheimer’s disease. According to the Alzheimer’s Association, the ten warning signs of Alzheimer’s disease are: 1. Memory Loss 2. Difficulty performing familiar tasks 3. Problems with language 4. Disorientation to time and place 5. Poor or decreased judgment 6. Problems with abstract thinking 7. Misplacing things 8. Changes in mood or behavior 9. Changes in personality 10. Loss of initiative
What is considered normal memory loss vs. early Alzheimer’s disease symptoms? Normal
Early Alzheimer’s Disease
Can’t find keys
Routinely place important items in odd places
Search for casual names and words
Forget names of family members and common objects
Briefly forget details of conversation
Frequently forget entire conversations
Can’t find a recipe
Can’t follow directions
Forget to write down a check
Can no longer manage a checkbook
Cancel a date with friends
Withdraw from usual interests
Miss an occasional turn while driving
Get lost in familiar places
When should you seek help? Not all memory loss is Alzheimer ’s disease. When symptoms appear suddenly, it is very important to seek consultation from a medical professional to evaluate the symptoms. Conditions such as a stroke, brain tumors, drug interactions, thyroid problems, and seizures should be treated immediately. Treatment in some of these cases in a timely manner is crucial. Alzheimer’s disease cannot be diagnosed in a single test. It takes an expert practitioner, neurologist, or geriatrician to make a reason-
Con’t from Page 1 Bipolar Disorder~ several likely reasons; among them, denial of the illness, poor access to treatment, misdiagnosis and the resulting mistreatment, and atypical presentation of the disorder. The presentation of bipolar disorder can be confused with the symptoms in unipolar depression, substance abuse, alcohol dependency, medical conditions (e.g., lupus and delirium), ADHD, primary psychoses (such as schizophrenia), and borderline personality disorder. It is important to realize, however, that bipolar disorder is not always a diagnosis of exclusion; it can coexist with medical, and other psychiatric conditions (such as ADHD, substance abuse, and anxiety disorders). As a matter of fact, untreated bipolar patients are more likely to develop additional psychiatric disorders than the treated patients. Needless to say, the earlier the correct diagnosis is made, and treatment initiated, the more favorable is the course and the prognosis of the illness. Fortunately, there is an armament of medications (mostly manufactured or discovered in the last two decades) available to treat bipolar disorder. Some of these medicines are not officially approved by FDA for bipolar disorder; they are effective but have not been submitted to the FDA for approval. Unfortunately, a significant minority of the bipolar patients do not respond well to the existing medications.
able diagnosis by excluding other causes of memory loss. By gathering family history and ordering medical tests, this exclusion can be determined. Once diagnosed, there are some options for treatment. These include standard medications prescribed by a doctor to slow or halt the progression of Alzheimer’s disease. Some may even opt for newer medications and procedures which can predict if they are a genetic carrier by participating in a clinical trial.
Con’t from Page 1 Coping With Depression They either cannot tolerate the medications or, they have only a partial response to these. These limitations, plus the fact that the patients often lack medical insurance (or adequate coverage), deprives many patients from appropriate diagnosis and treatment. Consequently the patients, along with their loved ones and the society at large, continue to suffer from their pain and impairment. One small, yet very significant, solution for many of these patients is to enroll in one of the many clinical trials specifically for Bipolar Disorder. At Pharmacology Research Institute, we have ongoing clinical trials for various psychiatric conditions, usually including Bipolar Disorder. Any interested individual can be promptly scheduled for a psychiatric evaluation by a competent and experienced board-certified psychiatrist here at PRI. An individual seeking such a (confidential, no-cost) consultation can usually be properly diagnosed and, if interested, familiarized with available, or soon to be available, clinical trial treatment options. Yes, Bipolar Disorder is serious, very serious; but with proper diagnosis, treatment and compliance, one’s quality of life can be very good! Excerpted from the article, “Bipolar Disorder~ Definitions, Descriptions and Options” by Nader Oskooilar, M.D., Ph.D., Medical Director. Please visit our website at: www.priresearch.com for the full text. Page 2
The latest pharmacological treatments are effective and can help to prevent major complications like the ones mentioned above (mainly suicide, loss of a job or involvement in drugs or alcohol). There are also other modalities of treatment such as individual therapy, cognitive behavioral therapy, and exercise; h o w e v e r, t h e m a i n s t e p i n t h e r i g h t direction is to get diagnosed. If you or someone you know suffers from depression, just know that help is out there! PRI can be the answer.
This Issue’s Featured Team Member Hellena Manuputty, R.N., M.S.N. by: Mellissa Henry, R.N., M.S.N., N.P.
Hellena Manuputty, R.N., M.S.N., is a talented and very unique member of our clinical research team at the Los Alamitos office. Hellena’s family migrated to Southern California from Jakarta, Indonesia when she was eight years old. Hellena’s name is derived from the Dutch spelling and means “light.” Hellen, as she is known to us, has been a shining light for both study participants and team members here at PRI.
Hellen brings a wealth of knowledge and unique experiences making her a highly valuable addition to the PRI team. She graduated from Cal Poly Pomona with her bachelor’s degree and continued her education at Samuel Merritt University where she obtained her master’s degree in nursing. Her work history includes positions in research labs, pharmacies, doctor’s offices and hospitals. Even more noteworthy is Hellen’s desire to give back to others. Her passion to help has driven her to volunteer for numerous community service activities dating back to her high school days. Hellen has been involved with community outreach activities sponsored by her church as well as volunteering at various hospitals. Most recently, Hellen’s need to reach out and help, influenced her to become a volunteer at the American Foundation for Suicide Prevention.
This volunteer experience afforded her the opportunity to work with surviving families and friends who lost loved ones to suicide. Hellen also took part in a suicide awareness program geared at educating the public and other healthcare professionals about suicide prevention and mood disorders. Hellen enjoys her position here at PRI because she is taking part in conducting clinical trials that are paving the way for cutting edge treatments to become available to the public at large. She is also able to witness both the long-term and short-term benefits participants receive by participating in clinical trials. Everything Hellen does exhibits an extraordinary level of care and concern. Study participants have repeatedly commented about her compassion and kind hearted nature. We are very fortunate to have such a diverse and adaptable individual as a member of the PRI team.
Are You A Caregiver... Who Can Use A Little Relief ? by: Charles S. Wilcox, Ph.D.
If you’re a caregiver for someone with Alzheimer’s disease, we’re pleased to extend to you an offer for some potential relief! Donahue Vanderhider, M.S.G., a graduate of the USC School of Gerontology, has invested (literally) hundreds of hours developing a Caregiver Relief® CD, which PRI is offering (FREE) to the first 50 (present or past) study participant caregivers who contact us. For a quick glimpse, feel free to check out the website www.caregiverrelief.com.
Donahue was chosen by the Los Angeles County Area on Aging and L.A. Caregiver Resource Center to create stress management, guided imagery, tools for caregivers. The Caregiver Relief® CD provides caregivers with the resources to meet their emotional, physical and spiritual needs, as well as those of their loved ones. We invite our current and prior study caregivers to contact us to obtain one of these CDs at no cost....
EYE ON IT What’s New at PRI? MODERATE-TO-SEVERE ALZHEIMER’S? Currently Taking Namenda®? While there are more than 80 potential new Anti-Alzheimer’s disease medications in some stage of development, there are very few opportunities to enroll in studies once an individual’s disease has progressed to the middle or later stages. One of our newest studies is specifically designed for patients (and their caregivers) now facing the increasing challenges of moderate-to-severe Alzheimer’s. We are pleased that this program also enables patients to continue taking Namenda® (the only currently marketed medication approved by FDA for the treatment of moderate-to-severe Alzheimer’s) plus receive the benefits of participation in this Phase-III study!
Adult Attention Deficit Disorder [ADHD] We just recently launched a new Adult ADHD study at our Los Alamitos office! This special study also provides the participants (ages 18to-55 years) with very comprehensive pre- and post-study eye exams, with a board-certified ophthalmologist~ also at no charge! These studies usually enroll quite quickly. If you’re an adult with ADHD, we encourage you to call us today!
FEELING SYMPTOMS OF DEPRESSION? Depression impacts the lives of one-in-five Americans at some time... PRI has been on the leading edge of depression research since 1975! We have an excellent line-up of new studies for the treatment of depression.
Depression Augmentation: Sometimes more is better! Recent scientific literature indicates that, for a significant percentage of patients, some people receive good - but incomplete - relief from any one antidepressant. In their case, the addition of a second medicine, with its own unique mechanism of action, enables patients to receive increased relief and benefits from a dual-action to attack and ameliorate their symptoms. At PRI’s Newport Beach office, we’re conducting a new Depression Treatment Augmentation study, with a widely prescribed marketed antidepressant, plus a research medication. For more information, or to schedule your initial consultation, call us today! The following studies are enrolling now, at all three locations: Adult Depression? For adults experiencing the feelings and symptoms of depression most days, most-of-the-day, for at least four weeks, we have some very patient-friendly new studies! Are previously enjoyable, satisfying and/or pleasurable Page 3
activities no longer pleasurable for you? Do you feel sad? Blue? Detached? Indifferent? Maybe even irritable? T h e r e ’s m o r e t h a n h o p e ; t h e r e ’s P R I !
Treatment Resistant Depression? Depression can sometimes be difficult to treat and the first, second or even third antidepressant may not work well for you. If so, you’re not alone. A significant percentage of people are disappointed by their (initial uses of) antidepressants. At PRI, we have new programs specifically designed for people who were not (fully) helped by their prior antidepressants. Please don’t give up; we encourage you to call PRI! Bipolar Depression? Mood Swings?
Have you ever been diagnosed with Bipolar Type-I or Bipolar Type-II? The degree to which the identification, diagnosis and successful treatment of Bipolar Depression has progressed over this past decade is very promising; and even more hope is on the horizon! We have a new Bipolar Depression study, for persons aged 18-to-65, enrolling (now) at all three PRI locations!
Did You Know? Health Notes by: Charles
S. Wilcox, Ph.D.
EVER FEEL DEPRESSED...AND ALONE? J.K. Rowling I t ’s h u m a n n a t u r e t o a s k “ W h y m e ? ” Boris Yeltsin Mike Wallace Olivia Newton-John In harmony with this question, for many of us, Sheryl Crow it’s also ‘human nature’ to take a little solace Princess Diana Rodney Dangerfiled in knowing that regardless of one’s age, ap- Vincent Van Gogh W o l f g a n g A m a d eus Mozart pearance, gender, education, ethnicity, wealth, religion, power, position or (yes) even innermost personal philosophy, depression can get Winston Churchill in 1940 Churchill nicknamed its grasp on anyone. As our society has grown his depression “Black Dog” (as a metaphor) and matured, the prior stigma of depression has in an effort to convey his familiarity with, and attempted mastery of, his clinical been overshadowed by the promise of, and podepression.... It was later written “...(he) tential for, very effective treatments. While those became the hero that he always dreamed of us in the scientific research arena [and espe- of being...a man who could dream dreams cially our team here at PRI] consider the hundreds of victory when all seemed lost...” of thousands of people who participate in clinical research studies to be the real heroes [please see Brooke Shields (in her book Down Came the more on “heroes” in our next PRI Bulletin!], many Rain) shared that she “felt like a stranger...(and) “well-known” folks have played a key role as well. had thoughts of jumping from a window...Thanks to the antidepressant Paxil® and a sympathetic Indeed, the bravery of many famous people “opening- b a b y n u r s e . . . a b l e t o r e c o v e r . ” up” and sharing their challenges, trials and triumphs – when they were suffering from depression – has also Ashley Judd (when speaking of her depression proven to be de-stigmatizing and, oftentimes, very and [successful] treatment) stated, “I was uni n s p i r i n g a s w e l l . B e l o w i s a s m a l l happy and now I’m happy. Now, even sample of “Famous People and Depression”: when I’m having a rough day, it’s better than my best day before treatment!” Abraham Lincoln Jim Carrey Janet Jackson Buzz Aldrin Clearly, whether one is rich and famous or not, Billy Joel Mark Twain depression is an illness, not a weakness. Most Natalie Cole Naomi Judd importantly, depression is treatable...and the Marilyn Monroe Terry Bradshaw sooner the better!! Page 4
The PRI Bulletin is an official publication of Pharmacology Research Institute and is intended for patients and friends of the Institute. PRI does not rent, sell or trade its mailing list with any other organization or company. Your personal information is kept completely confidential. Inquiries and changes of address may be directed to any of the sites below. Medical Directors Jon F. Heiser, M.D. Daniel E. Grosz, M.D. Nader Oskooilar, M.D., Ph.D. Associate Medical Directors E. Cynthia Cabrera, M.D. Don F. De Francisco, M.D., Ph.D. Clifford Feldman, M.D., J.D. Executive Director Charles S. Wilcox, Ph.D. PRI Bulletin Editors Rachel Gotiong Janet L. Minter Site Coordinators/Office Locations Mellissa Henry, R.N., M.S.N., N.P. 4281 Katella Ave., Suite 115 Los Alamitos, CA 90720 714/827-3668/ Fax: 714/827-3669 Email: losalamitos@priresearch.com Barbara B. Katz, R.N., C.C.R.C. 1601 Dove Street, Suite 290 Newport Beach, CA 92660 949/752-7936/ Fax: 949/752-1412 Email: newport@priresearch.com Judy Morrissey, R.N., M.S.N., C.C.R.C. 6345 Balboa Blvd. Bldg III, Ste 363 Encino, CA 91316 818/705-7450/ Fax: 818/705-7454 Email: encino@priresearch.com Check out our newly updated website at: www.priresearch.com
The PRI Bulletin
Issue Vol. 20 No. 1 Fall/Winter 2009
THE PRI BULLETIN Pharmacology Research Institute PO Box 1645 Los Alamitos, CA 90720
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