Frequently Asked Questions
(ACURIAN PROJECT CODE: 1073-GAD)
  1. About This Clinical Research Trial
  2. Other Questions
I.   About This Clinical Research Trial
Clinical research trials
What is a clinical research study?
Clinical studies are conducted by scientists to determine the safety and effectiveness of investigational medications in humans.
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What are the risks and benefits of participating in a clinical research trial?
Participating in a clinical trial may have benefits, but there are also risks. Study participants may experience side effects, which are sometimes serious. The investigational drug may not be safe or effective, or as safe or effective as the standard therapy. Study participants may play an active role in helping to advance the science regarding their conditions, although there is no guarantee that participation in this trial will advance scientific knowledge. The study doctor will discuss all the risks and benefits with you during your first office visit.
You will be presented with an Informed Consent form that every research study participant must read, understand and sign before enrolling into the trial. The Informed Consent form lists in detail the most common known risks and side effects of the investigational drug.
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How will I know if I may be eligible to participate in a research trial?
We are going to ask you a series of preliminary questions that will help determine if you may be eligible or "prequalify" for this clinical research study. At the end of these questions, if you prequalify, you will be referred to a participating research center for additional screening to determine if you're eligible.
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Your personal information
How did you get my name?
If you received a letter or an email informing you of this clinical research study, you were contacted by Acurian. Acurian is a company that specializes in informing people about clinical research opportunities in their area.
Acurian received your name when you provided it either to Acurian at their website, to a third party through a survey in a magazine, a survey you may have received in the mail, or elsewhere.
When you provided your name, you also indicated an interest in receiving information about this health condition. Acurian did not receive your information from your doctor or any other health professional, and your confidentiality has not been compromised in any way.
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How do I opt-out?
Please contact Bristol-Myers Squibb Customer Relations at 1-800-332-2056
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How will the information that is collected be used?
Your responses to the questions will be compared to the enrollment criteria for this clinical research study to help determine your eligibility to be screened for participation in the trial. If you consent, the information may be used for additional purposes described in the informed consent document.
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How will the information that is collected be used/Why do you need my personal information and contact information/Does anyone have access to my personal information?
Your responses to the questions will be compared to the enrollment criteria for this clinical research study to help determine your eligibility to be screened for participation in the trial. If you consent, your information may be used for additional purposes described in that consent. Only the study sponsor or agents acting on its behalf the institutional review board and the United States Food and Drug Administration (FDA) will have access to your personal information for the purposes described in your consent form.
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Miscellaneous questions
Is there a doctor in my area? (Question is asked prior to call going through the screener)
In order to find out if there is a study doctor in your area, we need to ask you some eligibility questions about yourself.
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Will there be any cost to me if I participate in a study (i.e., physical exams, medications)?
No. All study-related exams, laboratory work and study medications are included at no cost.
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Will I be paid for my participation in this study?
The study doctor will be able to provide information about this.
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Will I receive the study drug or a placebo (a treatment not containing active drug)?
You will have a 40% chance of receiving the study medication, a 20% chance of receiveing a marketed drug for anxiety, and a 40% chance of receiving placebo (inactive substitute). However, neither you nor the study doctor will know which study treatment you are taking.
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How long will I need to be in the study?
If you qualify and decide to participate, your participation will last about 6 months and involve a total of about 11 visits to a local research doctor's office, which is about 1 visit per week.
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Is the drug experimental/Is the drug FDA approved?
The drug is still considered to be investigational, which means that it is not approved by the FDA. It is being investigated to determine if it is safe and effective for the treatment of generalized anxiety disorder in women.
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Can you give me/mail me more information about this study?
You can visit www.acurian.com for more information about this study.
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Do you have any information on generalized anxiety disorder and medications available to treat them?
For that information, I recommend that you speak directly to your health care provider.
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How long will it be until I'm contacted by the study doctor's office?
You should be called within one week by someone in the office of the study doctor. (If it has already been a week, tell the caller to contact the site directly.)
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Who are you at the Call Center?
Alliance Healthcare Information is a company hired by pharmaceutical companies to recruit study participants for clinical studies. We are recruiting potential participants throughout the United States to participate in this study.
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Where are you located?
Alliance Healthcare Information is located in Pennsylvania.
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Can I enroll my friend or relative?
No, but please give them this number you just reached us at (or if does not have it written down, call 1-800-651-2161). Our business hours are Monday through Friday, 8:00 AM 8:00 PM, Eastern Time. We look forward to speaking with him or her.
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I want to be considered for future studies.
You have the option to have us keep your information retained for consideration in future studies.
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I'd like to discuss your marketing or media needs.
All of the media has been purchased for this study.
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I am a physician who is interested in being an investigator in the study.
Physicians interested in learning about being an investigator in a clinical study should call Tasha Ennis at 203-677-6764.
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Which pharmaceutical company is sponsoring this study?
Bristol-Myers Squibb is the sponsor of this trial.
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Does my doctor have to give his/her permission?
No, but we recommend that you contact your physician, or you may give the study doctor permission to contact them to discuss your participation
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Should I still see my regular doctor?
Yes. Participants should see their regular doctor for non-study-related medical care.
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Should I tell my personal physician about this trial?
Yes, you should speak to your health care professional about all medical issues.
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Any questions regarding birth control
If you pre-qualify for the study, please speak to the study doctor regarding birth control
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Should I tell my insurance provider about this trial?
The pharmaceutical company sponsoring this trial will pay for the costs of the clinic visits, procedures and study drug required by the study. However, if you receive medical treatment from the study doctor during this trial that is part of your standard medical care (i.e., not required by the study protocol), such costs may be billable to insurance. You should consult your insurance policy and ask questions of the study doctor. (NOTE to operator: during the course of some trials, a participant may receive medication or treatment which is not required by the protocol, but is part of the standard of care for the participant's underlying condition. Any procedures or services performed as part of the standard care may be billed to Insurance.)
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How long will the first office visit take?
You will be given a study related evaluation. The length of the office visits vary. The study doctor's office should be able to give you an idea of how long the visit will be.
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Why didn't I qualify?
I do not have information about why you did not qualify. Once you have completed the questionnaire, the computer determines whether you prequalify for the study. Individuals qualify or disqualify based on their answers to questions related to the research study's criteria.
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Why do you need my phone number/ Refused to provide phone number
Your telephone number is required by the study site as a means to contact you to schedule an appointment for further screening.
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What is the phone number to the investigator site/physician's office?
The telephone number for the study site you selected will be provided to you in a letter, which will be sent within one business day.
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When will the study site be calling me back? Can they call me back in the evening?
We will let the study doctor's office know what the best time to reach you is.
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What does it mean to be referred?
Once we determine if you prequalify by answering some preliminary questions, with your permission, we will direct your prequalification answers to a study site for final determination of your eligibility to participate in the clinical trial.
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What is considered child bearing potential?
All females who have begun menstruating are of child bearing potential (able to have children).
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Will I be reimbursed for transportation or parking?
The study site will be able to give you more information regarding reimbursement.
Recording FAQs
Which state requires the audio recording?
Certain states require us to record the call.
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How can I get information without you recording my call?
Please visit www.AcurianTrials.com for more information about this study or go to www.clinicaltrials.gov to find information about clinical trials
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Suicide Protocol
Please follow the BMS approved protocol which is Alliance's suicide protocol
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Glossary
Alzheimer's Disease
Alzheimer's Disease is a disease that causes memory loss. It is caused by a gradual loss of brain cells. Its symptoms include a gradual loss of memory, problems with reasoning or judgment, difficulty in learning, loss of language skills and decline in the stability to perform routine tasks.
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Angina
Angina is chest pain due to an inadequate supply of oxygen to the heart muscle. The chest pain of angina is typically severe and crushing.
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Bipolar Disorder
Bipolar disorder causes dramatic mood swings - from overly "high" and/or irritable to sad and hopeless and then back again, often with periods of normal mood in between. Severe changes in energy and behavior go along with these changes in mood. The periods of highs and lows are episodes of mania and depression.
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Cushings Disease/syndrome
Cushing's syndrome is a condition that occurs when your body is exposed to high levels of the hormone cortisol for a prolonged period of time. Sometimes called hypercortisolism, Cushing's syndrome can occur when your adrenal glands, located above your kidneys, make too much cortisol. It may also develop if you're taking high doses of cortisol-like medications (corticosteroids) for a prolonged period.
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Chronic Obstructive Pulmonary Disease (COPD)
COPD is any disorder that persistently obstructs bronchial airflow. COPD mainly involves two related diseases - chronic bronchitis and emphysema. Both cause chronic obstruction of air flowing through the airways and in and out of the lungs. The obstruction is generally permanent and becomes worse over time.
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Dementia
Dementia is the significant loss of intellectual abilities such as memory capacity, severe enough to interfere with social or occupational functioning.
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Emphysema
Emphysema is an abnormal condition of the lungs marked by decreased ability to breathe normally. It is associated with smoking or chronic bronchitis or old age.
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Fibromyalgia
Fibromyalgia is a syndrome characterized by chronic pain, stiffness, and tenderness of muscles, tendons, and joints without detectable inflammation.
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Generalized Anxiety Disorder (GAD)
A condition characterized by 6 months or more of chronic, exaggerated worry and tension that is unfounded or much more severe than the normal anxiety most people experience. People with GAD usually expect the worst. They worry excessively about money, health, family or work even when there are no signs of trouble.
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HIV (AIDS)
HIV is a viral infection that gradually destroys the immune system. It is passed from person to person through bodily fluids.
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Hysterectomy
A hysterectomy is an operation to remove the uterus (womb).
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Obsessive Compulsive Disorder (OCD)
Obsessive Compulsive Disorder (OCD) is an anxiety disorder and is characterized by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors (compulsions). Repetitive behaviors such as hand-washing, counting, checking, or cleaning are often performed with the hope of preventing obsessive thoughts or making them go away. Performing these so-called rituals, however, provides only temporary relief and not performing them markedly increases anxiety.
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Panic Disorder
Panic disorder is characterized by sudden attacks of fear and panic. The episodes may resemble a heart attack. They may strike at any time and occur without a known reason but more frequently are triggered by specific events or thoughts, such as taking an elevator or driving.
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Parkinson's Disease
Parkinson's disease is a disease of the nervous system. It is characterized by a fixed face that has no expression, a tremor or slight shaking even when sitting still, a slowing down of body movements, a tendency to walk with short steps that become faster and faster, a peculiar posture and weakening muscle. The disease progresses slowly and is caused by degeneration of an area of the brain.
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Post Traumatic Stress Disorder
Post traumatic stress disorder is a common anxiety disorder that develops after exposure to a terrifying event or ordeal in which grave physical harm occurred or was threatened. Family members of victims also can develop the disorder.
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Schizophrenia
A mental illness in which the person suffers from distorted thinking, hallucinations and a reduced ability to feel normal emotions.
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Thyroid Disease
If you have a thyroid disease, your body uses energy more slowly or quickly than it should. A thyroid gland that is not active enough, can make you gain weight, feel fatigued and have difficulty dealing with cold temperatures. If your thyroid is too active, it makes more thyroid hormones than your body needs. Too much thyroid hormone can make you lose weight, speed up your heart rate and make you very sensitive to heat
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What is TIA (transient ischemic attack)?
Transient ischemic attack is commonly known as a mini stroke
Some people call a transient ischemic attack (TIA) a mini-stroke, because the symptoms are like those of a stroke but do not last long. A TIA happens when blood flow to part of the brain is blocked or reduced, often by a blood clot. After a short time, blood flows again and the symptoms go away.
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Do you have a website?
Yes there are two websites for this trial they are www.AcurianTrials.com or www.ClinicalTrials.gov
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II. Other Questions
Screening Online
What is an online screening questionnaire?
The online screening questionnaire asks a series of relevant health-related questions and compares the responses to the enrollment criteria for this clinical research trial to help determine your eligibility to participate in a specific trial.
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What should I do if I have a question about the online screening questionnaire?
If you are unsure about a particular question or do not understand what you are being asked, please select the appropriate help topic link. The Help and Synopsis buttons will always be available if you have questions or concerns while completing the questionnaire. We encourage you to discuss any detailed medical questions with your physician or other healthcare provider. You may also contact us by email or call the toll-free number, which was provided in the message that you received, to complete the screening questionnaire by telephone. Our call center operators are available Monday through Friday between 8 a.m. and 8 p.m. (Eastern time).
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How long will it take to complete the online screening questionnaire?
The length of time required to complete the online screening questionnaire will vary from person to person and may also vary depending on the speed of your Internet connection or browser. For your convenience a progress bar located at the bottom of the page indicates your relative position within the survey, which can be used as an indicator of the length of time remaining until the questionnaire will be complete.
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Getting Around
How do I navigate around the online screening questionnaire?
While completing the online screening questionnaire, please use the Next and Back buttons provided at the bottom of the screen to move forward and backward through the questionnaire. Please DO NOT use your Internet browser's FORWARD and BACK buttons.
After completing a question, select the Next button to move to the next question; select the Back button to move to a previous question.
The Help and Synopsis buttons will always be available if you have questions or concerns while completing the questionnaire.
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How do I change a response to a specific question?
If you would like to revise a response, select the back button to navigate to that question and revise as necessary. You will also have the opportunity to review, confirm, and revise your responses upon completion of the questionnaire, when a summary of your responses to the questions will appear.
Please note, however, that the series of questions may change based on any revisions you make to your responses. Therefore, if you revise any response, you will need to recheck your responses for the subsequent questions.
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How will I know if I am eligible to participate in a research trial?
If your responses establish that you pre-qualify for this trial, you will be asked to select from a list of convenient research locations. Your completed questionnaire will then be forwarded to the research location that you choose, and a member of the research study staff there will contact you to schedule an appointment for further evaluation.
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Once I complete the online screening questionnaire, how do I get back onto the Internet?
Once you have clicked on the Submit button and have reached our "Thank you" page, you can follow the link on that page to the Acurian Web site, or you can simply use one of your bookmarks or type in a URL to go to another site on the Internet.
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What if I have questions or concerns that are not answered here or elsewhere in the Help section?
We encourage you to discuss any detailed medical questions with your physician or other healthcare provider. You may also contact us by email if you have questions about completing the online screening questionnaire.
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Technical Questions
How do I address any technical problems I encounter while completing an online screening questionnaire?
Unfortunately, we occasionally experience technical problems with our servers or online screening questionnaires. From time to time, our servers may become overloaded when too many people try to access a questionnaire at the same time. If you can't access the questionnaire or it takes too long to complete a particular survey, you can always complete the questionnaire at a later time.
If you are experiencing a technical problem, please feel free to contact us by email or call the toll-free number, which was provided in the message that you received, to complete the screening questionnaire by telephone. Our call center operators are available Monday through Friday between 8 a.m. and 8 p.m. (Eastern time).
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Which browser works best?
We recommend using Internet Explorer 5.0 (or subsequent releases) to view our online screening questionnaires. We also encourage AOL users to use the non-AOL version of Internet Explorer when completing our questionnaires because it produces a faster connection and a better overall experience. For your convenience, here is a link to download the latest version of Internet Explorer
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What other computer technology do I need to complete the online screening questionnaire?
All you need is an Internet browser (please see Which browser works best?) and an Internet connection to complete the online screening questionnaire.
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Acurian
What is Acurian?
Acurian is a company that helps potential research study volunteers and caregivers find doctors who are running research studies. In this way, Acurian helps to speed up the research process for new investigational medicines. For more information about Acurian and clinical research trials, visit their web site at www.acurian.com.
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Contact information
If you have comments, suggestions, or concerns about the online screening questionnaire, please feel free to contact us.
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After you have read these instructions, please close this window to return the online screening questionnaire.