Trial Information

Summary: First Episode Psychosis Study (CAFÉ)

What is the purpose of this study?
The purpose of this study is to compare the effectiveness and side effects of three antipsychotic medications (olanzapine, quetiapine, and risperidone) for the treatment of schizophrenia, schizophreniform, or schizoaffective disorder. All of these medications are currently approved by the FDA for use in the United States. We will study the main reasons why study participants stop taking each of the study medications because this problem sometimes is encountered in the treatment of your illness. We will also study the effects of the medications on your symptoms and functioning. We will study the side effects of the medications, your use of mental health services, and your quality of life.

What will I have to do if I decide to participate in this study?
You will participate in up to 24 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 study medication, visits once a week for the first six weeks of treatment, once every other week for the next six weeks, and then monthly visits for the rest of the study). There are three phases to this study. In the first 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 of a coin) to one study medication and do well, you may continue with the study medication up to four more months by entering phase 3 of the study.

You (and your family members, if they can attend study visits) will receive basic information about your illness, what you can expect to happen in the course of your illness, how you can deal with these changes, what you can expect from the study drug treatment and what mental health services and support groups are available to you locally.

You or your study doctor may decide to stop the study medication and end your participation in the study at any time.

What are the risks of participating in this study?
There is a risk that your symptoms of your illness will not respond to the study medication. Your symptoms may worsen if the study drug is ineffective for you. You will be told if any new information is learned which may affect your illness or influence your willingness to continue participation in this study.

Will I be paid to participate in the study?
You may receive up to $10 per visit for your participation in this study to help offset the cost of transportation and your effort. Payment will be made by check at the end of your study participation.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.