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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00330863 |
This study is designed to find out whether taking antipsychotic medication once every two weeks by injection compared to taking daily oral medication will help people with schizophrenia maintain better control of their symptoms.
Condition | Intervention | Phase |
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Schizophrenia Schizoaffective Disorder |
Drug: Risperidone microspheres Drug: Risperidone Drug: Olanzapine Drug: Quetiapine Drug: Ziprasidone Drug: Aripiprazole Drug: Paliperidone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Preventing Relapse: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE) |
Estimated Enrollment: | 304 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Injectable: Experimental
Participants assigned to receive long-acting injectable risperidone
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Drug: Risperidone microspheres
Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.
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Oral: Active Comparator
Participants assigned to receive oral "atypical" antipsychotic medication
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Drug: Risperidone
Target dose is 4 mg/day.
Drug: Olanzapine
Target dose is 15 mg/day.
Drug: Quetiapine
Target dose is 600 mg/day.
Drug: Ziprasidone
Target dose is 120 mg/day.
Drug: Aripiprazole
Target dose is 20 mg/day.
Drug: Paliperidone
Target dose is 6 mg/day.
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As is the case with many chronic illnesses, it can be challenging for people with schizophrenia to take multiple pills every day on a long-term basis. At the same time, missing or discontinuing the anti-psychotic medications that treat schizophrenia substantially increases the risk of relapse and re-hospitalization. This study will determine how effective long-acting injectable risperidone is compared to oral antipsychotic medications to help patients who have schizophrenia. Patients who enroll in the study will be randomly assigned to receive either long-acting injectable risperidone or to receive oral "atypical" antipsychotic medication. The "atypical" antipsychotics that are included for patients in the oral group are: aripiprazole, olanzapine, quetiapine, risperidone, and ziprasidone. Patients in the "oral" group will receive whichever of the five "atypical" antipsychotic medications they and their study doctor decide is best for them. Patients in the "oral" group will be allowed to switch to others of the five medications during the study if they and their doctor think that is best.
Patients in this study will be evaluated at the beginning of the study and then again every two weeks for up to 30 months (2 1/2 years). Each two-week visit will take about 20 minutes. At the visit, patients will receive medication and will be examined for side effects of the medications, their vital signs (heart rate, blood pressure, weight, and waist measurement) will be measured, and they will be asked a few questions about attendance at visits and taking medication. The visit that occurs every three months will take about one hour, instead of 20 minutes, and will include additional questions, an examination for muscle stiffness or abnormal body movements, and an interview from a member of the research team conducted using computer technology. In addition, blood and urine samples may be collected about seven times throughout the 30 months of the study treatment. Patients who enroll in this study after the halfway point of the study, may not receive a full 30 months of treatment, but it is planned that all patients will have the opportunity to receive no less than 18 months of treatment.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Susan E. Ray, MS, CCRC | 718-470-8442 | SRay@lij.edu |
United States, California | |
University of California, Los Angeles | Recruiting |
Los Angeles, California, United States, 91344 | |
Contact: Richard L Franco 818-832-2505 RLFranco@mednet.ucla.edu | |
Contact: Brenda V Alvarez 818-832-2505 brenda.v.alvarez@gmail.com | |
Principal Investigator: Alex Kopelowicz, M.D. | |
United States, Georgia | |
Medical College of Georgia, Department of Psychiatry | Recruiting |
Augusta, Georgia, United States, 30912-3800 | |
Contact: Dawn Montoya, B.S. 706-721-0409 dmontoya@mcg.edu | |
Contact: Rebecca Nichols, B.S. 706-721-4605 rnichols@mcg.edu | |
Principal Investigator: Peter F. Buckley, M. D. | |
United States, Iowa | |
University of Iowa College of Medicine, Psychiatry Research | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: Tim Holman, M.A. 319-335-6769 timothy-holman@uiowa.edu | |
Contact: Jane Kerr, B.S. 319-353-4955 jane-kerr@uiowa.edu | |
Principal Investigator: Del D. Miller, PharmD, M.D. | |
United States, Massachusetts | |
Harvard Medical School -- Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Lisa H. Raeke, M.A. 617-912-7840 LRaeke@partners.org | |
Contact: Kelsey Shannahan, B.A. 617-912-7868 kshannahan@partners.org | |
Principal Investigator: Donald Goff, M.D. | |
Harvard Medical School -- Dr. John C. Corrigan Community Mental Health Center | Recruiting |
Fall River, Massachusetts, United States, 02720 | |
Contact: Samantha S O'Connell, M.A. 508-235-7343 SSamberg@bidmc.harvard.edu | |
Contact: Amanda Fennessey, B.A. 508-235-7299 AFenness@bidmc.harvard.edu | |
Principal Investigator: Theo Manschreck, M.D. | |
United States, Nebraska | |
Creighton University | Recruiting |
Omaha, Nebraska, United States, 68131 | |
Contact: Kim A. Carroll, B.A. 402-345-8828 ext 22 KCarroll@creighton.edu | |
Contact: Wendy Taylor 402-345-8828 ext 20 wtaylor@creighton.edu | |
Principal Investigator: Daniel R. Wilson, M.D., Ph.D. | |
United States, New Mexico | |
University of New Mexico | Recruiting |
Albuquerque, New Mexico, United States, 87131 | |
Contact: Heather Hawk, CPhT 505-272-9552 hhawk@salud.unm.edu | |
Contact: Tara Biehl, M.S., CPhT 505-272-9544 tbiehl@salud.unm.edu | |
Principal Investigator: John Lauriello, M.D. | |
United States, New York | |
The Zucker Hillside Hospital | Recruiting |
Glen Oaks, New York, United States, 11004 | |
Contact: Susan E. Ray, M.S., CCRC 718-470-8442 SRay@lij.edu | |
Contact: Christopher M. Phillips, R.N. 718-470-8163 CPhillip@lij.edu | |
Principal Investigator: Alan Mendelowitz, M.D. |
Principal Investigator: | John M. Kane, MD | Steering and Implementation Center |
Study Director: | Nina R. Schooler, PhD | Steering and Implementation Center |
Study Director: | Stephen R. Marder, MD | Steering and Implementation Center |
Responsible Party: | North Shore Long Island Jewish Health System ( John M. Kane, MD ) |
Study ID Numbers: | U01 MH070007-01, U01 MH070023, U01 MH070011, U01 MH070009, U01 MH070008, U01 MH070017, UO1 MH070010, U01 MH070016, U01 MH070012, DSIR 83-ATAP |
Study First Received: | May 26, 2006 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00330863 History of Changes |
Health Authority: | United States: Federal Government |
Relapse Prevention Schizophrenia Injectable Medication |
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Olanzapine Risperidone Antiemetics Central Nervous System Depressants 9-hydroxy-risperidone Antipsychotic Agents Serotonin Uptake Inhibitors Serotonin |
Recurrence Schizophrenia Quetiapine Dopamine Mental Disorders Dopamine Agents Psychotic Disorders Peripheral Nervous System Agents Aripiprazole Ziprasidone Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Uptake Inhibitors Disease Attributes Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics 9-hydroxy-risperidone Schizophrenia Serotonin Antagonists Pathologic Processes Mental Disorders Therapeutic Uses Psychotic Disorders |
Aripiprazole Schizophrenia and Disorders with Psychotic Features Tranquilizing Agents Gastrointestinal Agents Risperidone Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Serotonin Uptake Inhibitors Recurrence Pharmacologic Actions Quetiapine Serotonin Agents Autonomic Agents Dopamine Agents |