SCHIZOPHRENIANOVEMBER2005

8:30 AM-5:00 PM ESTMonday through Friday Study Line:1-866-419-6830After Hours/Emergency Line:1-800-248-7228

On a Roll in 2006 1

Monitoring Success 1

Don’t Leave Home Without It 2

Who’s Hot & Who’s Not 2

Study Reminders 2

The Big Picture 3

Hughes Potter Manages Success 3

Subjects’ 24/7 Online Resource 4

U.S. Non-Cumulative Enrollment 4

Common Questions 4

1THE ZODIAC UPDATE

INSIDETHISISSUE

ZODIAC

Pfizer has extended the close of the ZODIAC study enrollment to February

2006. U.S. enrollment for the study has outpaced the rest of the world. With

the new deadline comes a challenge to exceed the goals originally set so that

the worldwide enrollment target can be met.

On a Roll in 2006

Pfizer is looking to U.S. sites to help reach the worldwide study goal of 18,000 patients. By extending the study close in the U.S. through February 2006, the Pfizer team has committed to contributing an incremental 700 randomized subjects to the ZODIAC study.

“Our success has been recognized, and that is an accolade that I want to pass on to all of the ZODIAC sites that have met or surpassed their goal thus far,” said Project Lead, Sybil Eng Ph.D. Director of Epidemiology. “But with opportunity, comes challenge. For us to reach the worldwide enrollment goal, we will need to continue randomizing patients at our current pace here in the U.S.”

Good luck one and all!

Sites that have reached the remarkable milestone of 50 patients should prepare for a monitoring visit. Thereafter, these visits will occur at each subsequent addition of 50 patients. Pfizer will be working with the North American Monitoring Group (NAMG) to conduct these visits which are called for by the Scientific Steering Committee (SSC).

Monitoring Success

SCHIZOPHRENIAZODIAC UPDATETHE

NAMG will also handle site activation visits for any new sites that may come on board in the home stretch. The process for handling all questions regarding the Study has not changed. Please direct your inquiries to the toll-free ZODIAC Study Line, and a Clinical Research Assistant will handle your request.

QUESTIONSCALLUS

1-866-419-6830

Pharmacy card violations are a problem that continues to grow. To date, over 1,700 of the nearly 18,000 enrolled patients don’t use their pharmacy card-62 patients in the last month alone. In the harshest terms, failure to use the card is a protocol violation, putting that patient’s data at risk for rejection. At the very least, missing pharmacy data creates a disruption of the larger collection network and could potentially compromise study outcomes.

The problem may be most acute in the Medicare and Medicaid populations. These patients are the least familiar with a card system and may be adding the study prescription to their Medicare or Medicaid accounts.

Over one-quarter of all enrolled ZODIAC patients fail to use their

Pharmacy Card when they get their prescription filled. Patient

habit may be driving the problem, we need to work together to find

a solution.

OVERVIEWPATIENTENROLLMENT

Card TricksPatients need your help! Here are some safety-net measures to ensure proper dispensing:

Make a notation at the top of each Study prescription: “To be paid by McKesson. Call 1-800-750-9835.”

Pre-print stickers inscribed: “To be paid by McKesson. Call 1-800-750-9835.” Affix these stickers on prescriptions as they are given to patients.

Staple the prescription to the prescription card.

Call ahead to the pharmacy before the patient gets his or her prescription filled.

Don’t Leave Home Without It

UPDATESSTUDYREMINDERS

u

u

Who’s Hot & Who’s Not

What can you do? Talk to your patients. Explain that their participation in the Study will help advance medical research and that even a seemingly small thing, like how they pay for their medication, makes a difference.

2 THE ZODIAC UPDATE

ZODIAC UPDATETHEZODIAC

The study protocol states, “Male and female patients newly treated for schizophrenia and those receiving continuing treatment will be eligible to be enrolled in this Study.” Unfortunately, this language implicitly excludes patients with a diagnosis of bipolar disorder.

The good news is that there is latitude when it comes to evaluating patients diagnosed with schizoaffective disorder. Since the ZODIAC study

is designed to mimic normal clinical

practice, this standard should apply

when considering schizoaffective

patients for inclusion into the Study. As

the enrolling physician, if you would

contemplate treatment with olanzapine

or ziprasidone for the patient outside the

confines of the Study, he or she would

indeed qualify for participation as long

as all other criteria have been met.

u

u

“Everyone wants to feel useful and be a part of something bigger than themselves,” said Ms. Hughes-Potter. “It’s no different for people with schizophrenia. Participation in the ZODIAC study brings a sense of purpose to patients who are frequently overlooked and not expected to contribute to society.”

In the office where she sees patients, Kathleen Hughes-Potter,

Advanced Registered Nurse Practitioner, has placed a small sign on her

desk that says, “Ask me about the ZODIAC Study.” Patients do! Most of

the patients she oversees in her large practice are recent “graduates” of

the public mental health system who are taking their first fragile steps

back into the world.

1

The Big Picture Hughes-Potter Manages Success

3THE ZODIAC UPDATE

ZODIAC UPDATETHEZODIAC

Ms. Hughes-Potter is the first to acknowledge that a 3,000-patient Medicare and Medicaid practice could potentially be a nightmare to administrate-especially for one who manages multiple research studies. Ms Hughes-Potter credits her office manager with keeping her on track by pre-assembling study document packets, identified by a study-specific, color-coded cover sheet. Each morning, pre-assembled ZODIAC packets get inserted in each scheduled patient appointment file that shows a diagnosis of schizophrenia.

Ms. Hughes-Potter has also grappled with Pharmacy Card compliance issues. “Medicare and Medicaid patients have a hard time remembering to use their card,” she laments. “They are used to a coupon system to receive their medication.”

Her solution? She puts labels on every prescription instructing the pharmacy to call McKesson at the toll-free number for approval to dispense the medication. “In an ideal world, every patient would remember the card. Unfortunately, most of my patients live in a less than ideal world.”

candidates,” said Ms. Hughes-Potter. “The ZODIAC study is great; it’s easy.” The 60 patients she has randomized since April of this year, appear to be ample evidence of this.

Ms. Hughes-Potter is most gratified that the Study lets her do something good for people.

When patients ask her about the study, Ms. Hughes-Potter tells them that their participation won’t change their treatment plan. As Study subjects they will keep their same appointment schedule, won’t need to undergo any additional tests and have the added assurance that they will be receiving a FDA-approved drug for a full year at no cost.

“What seems to motivate patients more than anything else is the desire to be a part of this. “When I tell them that their role is special because the Study involves gathering information from around the world to help physicians make better treatment decisions, they are flattered to be considered as

What information is most critical on the Questionnaire Pages ?

There are three key events that require submission of Questionnaire Pages to Covance:

subject randomization; subject contact that results in a change of medication, Study

withdrawal or a safety report; and Study completion. Upon subject randomization,

you should complete the first three Baseline Pages. Pay special attention to questions

pertaining to diagnosis date, as well as prior Ziprasidone and Olanzapine use and the

extent of use. When a patient reaches his or her one year milestone, complete the

12-Month Disposition. The final status of the patient must be classified in one of three

groups: completed the Study, did not complete the Study, or died. Patient contact report

pages are critical to the Study outcomes. Please complete page 4 immediately if you

change a subject’s medication or the subject experiences a qualifying safety event.

UPDATESCOMMONQUESTIONSQ

4 THE ZODIAC UPDATE

A

U.S. Non-Cumulative Enrollment

ZODIAC UPDATETHEZODIAC

Visit the ZODIAC study website at www.StudyForSchizophrenia.com. The site expands the information presented in the study brochure and should give patients, caregivers and family members enough information to make an informed decision about study participation. Please feel free to add this link to your website.

Subjects’ 24/7 Online Resource

The Website Includes:• An overview of the ZODIAC study

and the inclusion criteria• Facts about schizophrenia, including

definitions of clinically relevant terms

• General information about what it means to volunteer for a clinical study

• A downloadable copy of the study brochure

• A contact page for interested patients to receive more information

0

100

200

300

400

500

600

700

62

166174

2002 2003 2004 2005

Jan

Feb

Mar

Ap

r

May Jun

Jul

Au

g

Sep

Oct

Nov

DecJan

Feb

Mar

Ap

r

May Jun

Jul

Au

g

Sep

Oct

Nov

Dec

Feb

Mar

Ap

r

May Jun

Jul

Au

g

Sep

Oct

Nov

Dec

306

579596

478491486

351368

234

200

262

224

258

131

177172187

175168

147

81 76 81

10211192 84

7660

94

173182

144

102

142138122

Jan

Feb

Mar

Ap

r

May Jun

Jul

Au

g

Sep

Oct

147

198

167

141121

Global Cumulative Enrollment

16,430

WEBMATERIALS