SE Wok Compaen Otis, using, ad Rien the Tenet of Ft poe Piychoss: A Randonked Dae nd S2-Week Compatison EXHIB! Adult Consent Form yor Protocol: So77IL/O114 : IND NO 32, 132 Title of Study: Bflicacy and Tolerability of Olanzapine, Quetiapine and Risperidone in the Treatment of First Episode Psychosis: A Randomized Double Blind 52 Week Comparison, The CAFE Study Principal Investigator: Dr, Stephen Olson Co-Investigators: Drs. Charles Sehulz and John Vuchetich of the University of Minnesota Sponsor: AstraZeneca Pharmaceuticals 1, INTRODUCTION ow ate being asked to take part im a research study. Before you decide to participate it ie important fer you to undcistand why the research is being done, what it will involw ad the possible benefits, risks and discomforts to you of study participation. This process is known sz _informed consent”. This consent form describes the purpose, procedures, and possible boneie and risks of participating in this study. Please take time to read the following information ‘arefully and discuss it with tusted family, friends, or health care providers if you ‘wish. The investigators listed above are in charge of the study; other professional persons may help them or act for them, Your healthcare provider may be an investigator for tis esearch project, and as an investigator, is interested both in your clinical welfare and in the conduct of this study. The investigator is X being pald by AstraZeneca to conduct this study. AstraZeneca isthe pharmnaseation company that manufactures and markets the medication quetiapine (Seroquel), ‘Before entering this study Gr at any time during the study, you may ask for a second opinion about your cars ftem anothe, doctor who is in ‘no way associated with this study. You are not under any obligation to participate in a research project offered by your doctor. What are some general things you should know about research studies? Research studies arg designed to gain scientific knowledge that may help other people in the Entre. You may or may not receive any direct benefit ffom participating, There may also be risks associated with participating in research studies, Your participation is voluntary. You may refuse to participate, or may withdraw your consent ‘© participate in any study at any time, and for any reason, without jeopardizing yous future care HSC# o202MI7441 ps 000176 Version: 03/2503 Page 1 of 10SEW Compaen 2 Olamarine, Quer, and sprint Tena! of it EpsdePyharis A Randoms De nd 52-Week Compatson at this institution or your relationship with your doctor. You do not have to participate in research in order to receive treatment. Details about this particular study are discussed below. It is importent that you understand this information so that you can decide in a free and informed manner whether ‘you want to Participate. You will be given a copy of this consent form. You are urged to ak the investigalors named above, or staf members who may assist them, any questions you have about this study at any time. 2. PURPOSE OF THE RESEARCH STUDY ‘The purpose of this study is to compare the effectiveness and side effects of three antipsychotic medications: olanzapine, (Zyprexa®); quetiapine, (Seroquel®); and risperidone, Risperdal) for the treatment of schizophrenia, schizopbreniform, or schizoaffective disorder. All of they medications are currently approved by the FDA for use in the United States, at 24 institutions will participate in this study, including institution, You must be 16 to 40 years of age to this study will last for up to 12 months, 3: DESCRIPTION OF THE RESEARCH STUDY AND PROCEDURES Soni participate in up to 21 scheduled study visits (an initial visit to see if you qualify for the study, a baseline visit for additional tests and the assignment of a stady medication, visits see week forthe fist six weeks of treatment, once every other week for the next six weeks, and then monthly visits for the rest of the study). If you are an oulpatient you will come to the study doctor's hospitalized, the study doctor will come to you for the study vis e in your condition we will schedule extra study visits at no cost to you. sme There are two phases to this study. Inthe frst phase, you will participate in an evaluation to determine if you are eligible for the study. In the second phase, you will be randomly assigned Like the flip ofa coin) to one study medigation, and will participate up to one year, You ot your any time, This could be because the study antipsychotic did not work well enough for you, because of side effects, or for other reasons, Phase 1 Screening Visit: At your first study visit we will do the following: sce o20aMaTan 0s4 gogr?7 Version: 03725103 Page2 of 10biain written informed consent (this document) and answer any questions you may have about this study ack you about your medical history, including all medications you have taken,-and about your drug and/or alcohol use ae ‘onduct a physical examination which will include an opthalmologi detection of cataracts obtain vital signs conduct a complete psychiatric examination {ake a blood sample (1 tablespoon) for standard lab tests ‘The screening visit will take approximately 2 hours. Phase Xr the results of the screening tests indidife that you are eligible to exter Phase 2 of the study, we will schedule your second (baseline) study visit within 2 wees, Baseline Visit: This visit will take approximately 3 hours of your time, During this visit we will do the following: weer gcout Your curent symptoms, how it affects your day to-dey functioning and the history of how your illness began.. . ave You computerized and pencil and paper tests of your coordination, memory, and problem solving abilities, + ask you about your use of mental health services and your opinion about your ness and treatment. ‘measure your height, weight, and hip and waist size. ‘Vitel signs (systolic and diastolic blood pressure) will be measured, take a sample of hair to test for use of illegal drugs. biain a blood sample for evaluation of blood chemistries. It is important that you Go not eat or drink (except for water) for 8 hours before giving ws this blood sample, At the end of the baseline visit you willbe randomly (like the flip of a coin) assigned to receive Gioaules of olanzapine, or quetiapine, or risperidone, Your study doctor will werk with you to. discontinue any antipsychotic medicines you are taking and will start the new oné gradually, - Neither you nor the study doctor will know which study medication you have been given. This 's to make sure that neither you nor the study doctor's evaluation of how well the study drug works are affected by knowing what study drug you have been given, However, if in an smergency you need to know which study drug you have been taking, we oan find out If the study antipsychotic medication is not effective for you, o you are having side effects that Je Cannot tolerate, you will discontinue from the study. "Should you discontinue from the the study physician will provide immediate care for your psychotic illness, and will assist 204 a objaining follow-up treatment, including starting you on a new antipsychotic medicae if indicated, SCH O202MI7441 000178 - Version: 03/25/03 Page 3 of 10 ps4 |