DREAM - Disease Recovery Evaluation and Modification Study
Brief Description Of Study
This is a study to test a new way of taking a medication. The purpose of this study is to help understand if monthly injectable medication [paliperidone palmitate (Invega®]) or oral antipsychotic medication is better at preventing symptoms of schizophrenia or schizophreniform disorder from getting worse. During the study you will continue to take medication(s) you/your doctor feel are necessary for your treatment. Approximately 275 adults, ages 18 - 35 years old, will be in this study across the US.
Detailed Study Description
You will visit the Hospital of the University of Pennsylvania (HUP) about 28 times (over 20 months ) during the entire study. The study requires that you have a designated individual (e.g., family member, significant other, friend) who has knowledge of you and is generally aware of your daily activities. At each visit, we will gather basic information about you. For example, we may ask questions about your clinical symptoms, hospitalizations & other treatment, about your school, work & living situation, and about your satisfaction with your current therapy. There are also several tasks you will complete at several (about 5) visits: cognitive tests, physical exam, vital signs, blood draw (about 3 tablespoons), a urine test, and an ECG (measures your heart activity). This study has 3 main parts: Part I: Lasts 8 weeks. You will come to HUP 5 times during Part I. Part II: Lasts 37 weeks. You will come to HUP at least 8 times. Your study doctor may ask you to come in for an additional 2 visits or may contact you via phone. Part III: Treatment lasts 37 weeks. You will come to HUP at least 9 times. Your study doctor may ask you to come in an additional 2 visits or may contact you via phone.
Additional Information About The Study
You will receive the study drug and the medical testing needed for the study for free. There are no costs to you or your insurance for the study drug and study procedures. You will receive $93.00 for your time and to help cover your expenses for attending each study visit. This entire study is expected to take about 3 years.