The PRI BulletinIssue Vol. 20, No.1 ? Fall/Winter 2009

B i p o l a r d i s o r d e r , o r m a n i c - d e p r e s s i v e i l l n e s s ,i s a b r a i n d i s o r d e r w h i c h c a u s e s s i g n i f i c a n t a n d o f t e n d i s t u r b i n g m o o d s w i n g s . T h e y a r e d i f f e r e n tthan the mood swings that everybody might go through and they can frequently lead to personal pain and suffer-ing, as well as impairment in one’s social, interpersonal, andprofessional l i fe. Bipolar disorder, l ike most psychiatr icd i s o r d e r s , c a n b e c o n s i d e r e d a c o n t i n u u m , w h e r enumerous sub-types of the disorder, with different intensitiesand durat ions, can be visual ized. Depressive episodescan range from mild to severe; while the upswing of themood may be signif icant (mania in Bipolar I) or moder-ate (hypomania in Bipolar I I or in cyclothymia). Also,there can be what we sometimes categor ize as “mixede p i s o d e s ” ( s i m u l t a n e o u s m i x t u r e s o f d e p r e s s i v e a n d m a n i c / h y p o m a n i c s y m p t o m s ) . A d d i t i o n a l l y, t h e m o o dswings can be protracted, rapid, or ultra-rapid. Psychoticsymptoms such as de lus ions may a lso accompany theepisodes, especially in mania and severe cases of depression.

C o m m o n d e p r e s s i v e s y m p t o m s o f b i p o l a r d i s o r d e r include sadness, crying spells, severe anxiety, hopelessness,lack o f mot iva t ion , loss o f l ib ido , poor s leep, fa t igue,diminished concentration, diff iculty making decisions, anddisrupted appetite. Manic symptoms consist of increasedenergy, a decreased need for sleep, unusual hopefulness-to-grandiosity, a racing mind, impulsive decisions, euphoricmood, poor judgment, agitat ion, and unreal ist ic plans todelusional 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 theillness, before the correct diagnosis is made. This is due to

Bipolar Disorder:Definitions, Descriptions and Options!

by: Nader Oskooilar, M.D., Ph.D. Medical Director

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Depression can take many faces:It can present with not only a sad ordepressed mood, but also with ir-ritability, isolation, guilt, poor moti-vation and alterations in sleep. Itcan also lead to suicidal thinking and increased use of alcohol or drugsin an at tempt of sel f - t reatment.

Current research shows that depression is a true chemical imbalance, involvingsubs tances in the b ra in ca l led n e u r o t r a n s m i t t e r s s u c h a s : serotonin, norepinephrine and dopamine.

EYE ON ITWhat’s New at PRI?

Memory Loss Concerns?...For You or a Loved One?

Coping With Depressionby: Elsa Cynthia Cabrera, M.D.

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

MILD COGNITIVE IMPAIRMENT?a.k.a. Prodromal (Pre-) Alzheimer’s Disease?

MILD-TO MODERATE ALZHEIMER’S DISEASE?Currently Taking Aricept®?

PRI has a wide array of studies aimed atpotentially helping people with mild-to-severe memory loss, including studiesspecifically for the following, now enrol l ing at al l three locations!

There is “no question” that the absolute earliestpossible diagnosis and treatment of Mild-to-Moderate Alzheimer’s disease is the mostbeneficial course of action for patients and their loved ones! Our new study enablespatients to receive the benefits of the mostwidely prescribed anti-Alzheimer’s medica-tion (Aricept®), plus (also receive) the poten-tial benefits of a novel research medicinethat has now reached Phase-III in its develop-ment stage.

This unique and very important project, forpersons between 45 and 90 years of age, who have mild memory problems and donot have Alzheimer’s disease, is being con-ducted in the U.S., Canada, Sweden, Fin-land, Denmark and The Netherlands. PRIis very proud to have been one of the U.S.sites selected for participation in this prog-ram; moreover, the potential benefits forprogram participants are remarkable. Pleasecall the PRI office nearest you, for yourpersonal and confidential consultation/eval-uation for possible inclusion in the landmarkstudy! Your participation may not only proveto be beneficial to you, it may prove benefi-cial to millions of other people as well!

It’s a fact:

Memory Lossand

Alzheimer’sDisease:What You

Should Know

by: My-Linh Tong, R.N., M.S.N., N.P.

I t c a n o c c a s i o n a l l y h a p p e n t o e v e r y o n e . You’ re not ab le to f ind your car keys org lasses. You’re at the grocery store butyour list is at home. You forget the name of your ne ighbor or o f people you rare lysee. A lzhe imer ’s d isease may s tar t w i th slight memory loss, but, eventually progressesto irreversible impairment. Recognizing the normal changes, knowing what Alzheimer ’sdisease is, and knowing what to do are important in understanding memory loss and Alzheimer’s disease.

Accord ing to the A lzhe imer ’s Assoc ia t ion ,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 personality10. Loss of initiative

What is considered normal memory loss vs. earlyAlzheimer’s disease symptoms?

Normal Early Alzheimer’s Disease

Can’t find keys

Search for casual names and words

Briefly forget details of conversation

Can’t find a recipe

Forget to write down a check

Cancel a date with friends

Miss an occasional turn while driving

When should you seek help?Not a l l memory l oss i s A l zhe imer ’sd i s e a s e . W h e n s y m p t o m s a p p e a rsuddenly, it is very important to seek consultationfrom a medical professional to evaluate thesymptoms. Conditions such as a stroke,brain tumors, drug interactions, thyroidproblems, and seizures should be treatedimmediately. Treatment in some of thesecases in a t imely manner is crucial .

Alzheimer’s disease cannot be diagnosed ina single test. It takes an expert practitioner,neurologist, or geriatrician to make a reason-

able diagnosis by excluding other causes ofmemory loss. By gathering familyhistory and ordering medical tests, this exclusion can be determined.

Once diagnosed, there are someoptions for treatment. These includestandard medications prescribed bya doctor to slow or halt the progres-sion of Alzheimer’s disease. Somemay even opt for newer medicationsand procedures which can predict ifthey are a genetic carrier by participating ina clinical trial.

s e v e r a l l i k e l y r e a s o n s ; a m o n g t h e m , d e n i a lof the i l lness, poor access to treatment, mis-diagnosis and the resul t ing mistreatment, anda t y p i c a l p r e s e n t a t i o n o f t h e d i s o r d e r. T h e presenta t ion o f b ipo lar d isorder can be con-fused wi th the symptoms in un ipo lar depres-s i on , subs tance abuse , a l coho l dependency,medica l condi t ions (e.g. , lupus and del i r ium),ADHD, primary psychoses (such as schizophrenia),and borderline personality disorder. It is impor-tant to realize, however, that bipolar disorder is not always a diagnosis of exclusion; it can co-exist with medical, and other psychiatric condi-t ions (such as ADHD, subs tance abuse, andanxiety disorders). As a matter of fact, untreated bipolar patients are more likely to develop addi-t i ona l psych ia t r i c d i so rde rs than the t rea tedpatients. Needless to say, the earlier the correctdiagnosis is made, and treatment init iated, themore favorable is the course and the prognosis of the illness.

Fortunately, there is an armament of medications(mostly manufactured or discovered in the last twodecades) available to treat bipolar disorder. Someof these medicines are not officially approved byFDA for bipolar disorder; they are effective but havenot been submitted to the FDA for approval. Unfor-tunately, a significant minority of the bipolar patientsdo not respond well to the existing medications.

They either cannot tolerate the medications or, they haveonly a partial response to these. These limitations, plusthe fact that the patients often lack medical insurance(or adequate coverage), deprives many patients fromappropriate diagnosis and treatment. Consequently thepatients, along with their loved ones and the society atlarge, continue to suffer from their pain and impairment.

One small, yet very significant, solution for many of thesepatients is to enroll in one of the many clinical trials speci-fically for Bipolar Disorder. At Pharmacology ResearchInstitute, we have ongoing clinical trials for various psy-chiatric conditions, usually including Bipolar Disorder. Anyinterested individual can be promptly scheduled for apsychiatric evaluation by a competent and experiencedboard-certified psychiatrist here at PRI. An individual seek-ing such a (confidential, no-cost) consultation can usuallybe 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 withproper diagnosis, treatment and compliance, one’s qualityof life can be very good!

Con’t from Page 1Bipolar Disorder~

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 forthe full text.

Con’t from Page 1Coping With Depression

The latest pharmacological treatments areeffective and can help to prevent major complicationsl i ke the ones ment ioned above (main lysuicide, loss of a job or involvement in drugsor alcohol). There are also other modalities of t reatment such as indiv idual 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 d i r e c t i o n i s t o g e t d i a g n o s e d .

If you or someone you know suffers fromdepression, just know that help is out there!PRI can be the answer.

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Routinely place important items in odd places

Forget names of family members and common objects

Frequently forget entire conversations

Can’t follow directions

Can no longer manage a checkbook

Withdraw from usual interests

Get lost in familiar places

EYE ON IT What’s New at PRI?MODERATE-TO-SEVERE ALZHEIMER’S?

Currently Taking Namenda®?While there are more than 80 potential newAnti-Alzheimer’s disease medications in some stage of development, there are veryfew opportunities to enroll in studies once anindividual’s disease has progressed to themiddle or later stages. One of our neweststudies is specifically designed for patients(and their caregivers) now facing the increasingchallenges of moderate-to-severe Alzheimer’s. We are pleased that this program also enables patients to continue taking Namenda® (the only currently marketed medication approvedby FDA for the treatment of moderate-to-severeAlzheimer’s) plus receive the benefits of parti-cipation in this Phase-III study!

Adult Attention Deficit Disorder [ADHD]

We just recently launched a new Adult ADHDstudy at our Los Alamitos office! This specialstudy also provides the participants (ages 18-to-55 years) with very comprehensive pre- andpost-study eye exams, with a board-certifiedophthalmologist~ also at no charge! Thesestudies usually enroll quite quickly. If you’rean adult with ADHD, we encourage you tocall us today!

FEELING SYMPTOMS OF DEPRESSION?

Adult Depression?

For adults experiencing the feelings and symptoms of depression most days, most-of-the-day, for at least fourweeks, we have some very patient-friendly new studies!Are previously enjoyable, satisfying and/or pleasurable

Treatment Resistant Depression?

Depression can sometimes be difficult to treat andthe first, second or even third antidepressant maynot work well for you. If so, you’re not alone. Asignificant percentage of people are disappointedby their (initial uses of) antidepressants. At PRI, wehave new programs specifically designed for peoplewho 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-Ior Bipolar Type-II? The degree to which the identification,diagnosis and successful treatment of Bipolar Depres-sion has progressed over this past decade is verypromising; and even more hope is on the horizon! Wehave a new Bipolar Depression study, for persons aged18-to-65, enrolling (now) at all three PRI locations!

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Recent scientific literature indicates that, for a significantpercentage of patients, some people receive good - butincomplete - relief from any one antidepressant. In theircase, the addition of a second medicine, with its own uniquemechanism of action, enables patients to receive increasedrelief and benefits from a dual-action to attack and amelioratetheir symptoms. At PRI’s Newport Beach office, we’re conduc-ting a new Depression Treatment Augmentation study, with awidely prescribed marketed antidepressant, plus a researchmedication. For more information, or to schedule your initialconsultation, call us today!

Depression Augmentation: Sometimes more is better!

This Issue’s Featured Team Member

Depression impacts the lives of one-in-five Americans at some time... PRI has been on theleading edge of depression research since 1975! We have an excellent line-up of new studiesfor the treatment of depression.

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 talentedand very unique member of our clinical researchteam at the Los Alamitos office. Hellena’s familymigrated to Southern California from Jakarta,Indonesia when she was eight years old. Hellena’sname is derived from the Dutch spelling andmeans “light.” Hellen, as she is known to us,has been a shining light for both study partici-pants and team members here at PRI.

This volunteer experience afforded hert h e o p p o r t u n i t y t o w o r k w i t h surviving families and friends who lost loved ones to suicide. Hellen also took part in a suicide awareness program geared at educat ing the publ ic and other healthcare professionals about suicide p r e v e n t i o n a n d m o o d d i s o r d e r s .

Hellen enjoys her position here at PRIbecause she is taking part in conductingclinical trials that are paving the way forcutting edge treatments to become avail-able to the public at large. She is alsoable to witness both the long-term and short-term benefits participants receiveb y p a r t i c i p a t i n g i n c l i n i c a l t r i a l s .

Everything Hellen does exhibits an extra-ordinary level of care and concern. Studyparticipants have repeatedly commented about her compassion and kind hearted nature. We are very fortunate to have such a diverseand adaptable individual as a member of thePRI team.

Are You A Caregiver...Who Can Use A Little Relief ?

by: Charles S. Wilcox, Ph.D.

The following studies are enrolling now,at all three locations:

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 !

Hellen brings a wealth of knowledge and unique experiences making hera highly valuable addition to the PRIteam. She graduated from Cal PolyPomona with her bachelor’s degree and continued her education at SamuelMerritt University where she obtainedher master’s degree in nursing. Herwork history includes positions in researchlabs, pharmacies, doctor ’s off icesand hospitals. Even more noteworthyis Hellen’s desire to give back to others.Her passion to help has driven her tovolunteer for numerous communityservice activities dating back to herhigh school days. Hellen has beeninvolved wi th communi ty outreachactivities sponsored by her church aswell as volunteering at various hospi-tals. Most recently, Hellen’s need toreach out and help, influenced her tobecome a volunteer at the AmericanFoundation for Suicide Prevention.

If you’re a caregiver for someone withAlzheimer’s disease, we’re pleased toextend to you an offer for some potentialrelief! Donahue Vanderhider, M.S.G.,a graduate of the USC School of Gerontology, has invested (literally)hundreds of hours developing aCaregiver Relief® CD, which PRI isoffering (FREE) to the first 50 (presentor past) study participant caregiverswho contact us. For a quick glimpse,feel free to check out the websitew w w . c a r e g i v e r r e l i e f . c o m .

Donahue was chosen by the Los AngelesCounty Area on Aging and L.A. CaregiverResource Center to create stress manage-ment, guided imagery, tools for caregivers.The Caregiver Relief® CD provides care-givers with the resources to meet theiremotional, physical and spiritual needs,as well as those of their loved ones. Weinvite our current and prior study caregiversto contact us to obtain one of these CDsat no cost....

Did You Know?Health Notes

by: Charles S. Wilcox, Ph.D.

EVER FEEL DEPRESSED...AND ALONE?

I t ’ s h u m a n n a t u r e t o a s k “ W h y m e ? ”In harmony with this question, for many of us,it’s also ‘human nature’ to take a little solacein knowing that regardless of one’s age, ap-pearance, gender, education, ethnicity, wealth, religion, power, position or (yes) even inner-most personal philosophy, depression can getits grasp on anyone. As our society has grown and matured, the prior stigma of depression hasbeen overshadowed by the promise of, and po-tential for, very effective treatments. While thoseof us in the scientific research arena [and espe-cially our team here at PRI] consider the hundredsof thousands of people who participate in clinicalresearch studies to be the real heroes [please seemore on “heroes” in our next PRI Bulletin!], many“well-known” folks have played a key role as well.

Indeed, the bravery of many famous people “opening-up” and sharing their challenges, trials and triumphs –when they were suffering from depression – has alsoproven to be de-stigmatizing and, oftentimes, veryi 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 sample of “Famous People and Depression”:

Abraham Lincoln Jim CarreyJanet Jackson Buzz AldrinBilly Joel Mark TwainNatalie Cole Naomi JuddMarilyn Monroe Terry Bradshaw

Boris Yeltsin J.K. RowlingMike Wallace Olivia Newton-JohnPrincess Diana Sheryl CrowVincent Van Gogh Rodney DangerfiledW o l f g a n g A m a d e u s M o z a r t

Winston Churchill in 1940 Churchill nicknamedhis depression “Black Dog” (as a metaphor) in an effort to convey his familiarity with, and attempted mastery of, his clinicaldepression.... It was later written “...(he)became the hero that he always dreamedof being...a man who could dream dreamsof v i c to ry when a l l s eemed lo s t . . . ”

Brooke Shields (in her book Down Came the Rain) shared that she “felt like a stranger...(and)had thoughts of jumping from a window...Thanksto the antidepressant Paxil® and a sympatheticb a b y n u r s e . . . a b l e t o r e c o v e r . ”

Ashley Judd (when speaking of her depressionand [successful] treatment) stated, “I was un-happy and now I’m happy. Now, even when I’m having a rough day, it’s better than my best day before t reatment!”

Clearly, whether one is rich and famous or not,depression is an illness, not a weakness. Most importantly, depression is treatable...and thesooner the better!!

The PRI Bulletin is an official publicationof Pharmacology Research Institute

and is intended for patients and friendsof the Institute. PRI does not rent, sell or trade its mailing list with any other

organization or company. Your personalinformation is kept completely confidential.

Inquiries and changes of address may bedirected to any of the sites below.

Medical DirectorsJon F. Heiser, M.D.

Daniel E. Grosz, M.D.Nader Oskooilar, M.D., Ph.D.

Associate Medical DirectorsE. Cynthia Cabrera, M.D.

Don F. De Francisco, M.D., Ph.D.Clifford Feldman, M.D., J.D.

Executive DirectorCharles S. Wilcox, Ph.D.

PRI Bulletin EditorsRachel GotiongJanet L. Minter

Site Coordinators/Office LocationsMellissa Henry, R.N., M.S.N., N.P.

4281 Katella Ave., Suite 115Los Alamitos, CA 90720

714/827-3668/ Fax: 714/827-3669Email: losalamitos@priresearch.com

Barbara B. Katz, R.N., C.C.R.C.1601 Dove Street, Suite 290Newport Beach, CA 92660

949/752-7936/ Fax: 949/752-1412Email: newport@priresearch.com

Judy Morrissey, R.N., M.S.N., C.C.R.C.6345 Balboa Blvd. Bldg III, Ste 363

Encino, CA 91316818/705-7450/ Fax: 818/705-7454Email: encino@priresearch.com

Check out our newly updated website at:www.priresearch.com

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The PRI Bulletin Issue Vol. 20 No. 1 Fall/Winter 2009

THE PRI BULLETIN

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