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| Sponsored by: |
National Institute of Mental Health (NIMH) |
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00320671 |
Purpose
This study will evaluate the effectiveness of aripiprazole versus risperidone in treating people with first-episode schizophrenia.
| Condition | Intervention | Phase |
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Schizophrenia |
Drug: Aripiprazole Drug: Risperidone |
Phase IV |
| MedlinePlus related topics: | Psychotic Disorders Schizophrenia |
| Drug Information available for: | Risperidone Aripiprazole |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Preventing Morbidity in First Episode Schizophrenia, Part II |
| Estimated Enrollment: | 242 |
| Study Start Date: | December 2005 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
Participants will take aripiprazole for 12 weeks
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Drug: Aripiprazole
The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form for a total of 12 weeks. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week.
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2: Experimental
Participants will take risperidone for 12 weeks
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Drug: Risperidone
The dosage for risperidone will be is 1 mg to 6 mg per day in capsule form for a total of 12 weeks. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week.
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Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. Medications are available to alleviate the symptoms of schizophrenia, but many cause undesirable side effects. For example, two early second generation antipsychotics, olanzapine and risperidone, have been shown to be effective in treating schizophrenia symptoms, but cause rapid, substantial weight gain. There is a lower risk of such side effects with newer second generation antipsychotics, such as aripiprazole. Little is known, however, about the effectiveness of these newer medications in treating people with first-episode schizophrenia. This study will evaluate the effectiveness of aripiprazole versus risperidone for the treatment of first-episode schizophrenia.
Participants in this double-blind study will be randomly assigned to receive either aripiprazole or risperidone for 12 weeks. Additionally, all participants will take part in a Healthy Lifestyles program aimed at preventing weight gain. The Healthy Lifestyles program will provide psycho-education, supportive psychotherapy, and medication adherence counseling. Participants will report to the study site for baseline assessments upon study entry. They will then return to the study site weekly for 4 weeks, followed by once every 2 weeks for the remainder of the study. At each visit, treatment and metabolic outcomes will be assessed. Participants will meet with both a psychiatrist, who will evaluate progress and medication dosage, and a social worker, who will administer the Healthy Lifestyles Program. Blood and urine will be collected weekly for the first 4 weeks. Upon completion of the study, participants will receive follow-up care from clinical staff members who were not part of the research team.
Eligibility
| Ages Eligible for Study: | 15 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Joanne McCormack, MSW | 718-470-8446 | JmcCorma@lij.edu |
| Contact: Delbert Robinson, MD | 718-470-8195 | robinson@lij.edu |
| United States, New Jersey | |||||
| University of Medicine and Dentistry of New Jersey | Recruiting | ||||
| Newark, New Jersey, United States, 07107 | |||||
| Contact: Kristen Tobias, BA 973-972-8259 tobiaskg@umdnj.edu | |||||
| Contact: Charles Kellner, MD 973-972-5411 kellner@umdnj.edu | |||||
| Principal Investigator: Charles Kellner, MD | |||||
| United States, New York | |||||
| The Zucker Hillside Hospital | Recruiting | ||||
| Glen Oaks, New York, United States, 11004 | |||||
| Contact: Joanne McCormack, MSW 718-470-8446 JmcCorma@lij.edu | |||||
| Contact: Delbert Robinson, MD 718-470-8195 robinson@lij.edu | |||||
| Principal Investigator: Delbert Robinson, MD | |||||
| Sub-Investigator: Serge Sevy, MD | |||||
| Jamaica Hospital | Recruiting | ||||
| Jamaica, New York, United States, 11418 | |||||
| Contact: Tom Pawelzik, L Psic 718-206-7318 tpawelzi@jhmc.org | |||||
| Principal Investigator: Seeth Vivek, MD | |||||
| North Shore University Hospital | Recruiting | ||||
| Manhasset, New York, United States, 11030 | |||||
| Contact: Michael Sanders, MD 516-562-2011 msanders@nshs.edu | |||||
| Principal Investigator: Michael Sanders, MD | |||||
| Brookdale University Hospital and Medical Center | Recruiting | ||||
| Brooklyn, New York, United States, 11212 | |||||
| Contact: Leah Nicholls 718-240-5811 Nichollsld@yahoo.com | |||||
| Contact: Miriam Varghese 718-240-6219 | |||||
| Principal Investigator: Manoj Shah, MD | |||||
| Bronx-Lebanon Hospital Center | Recruiting | ||||
| Bronx, New York, United States, 10456 | |||||
| Contact: Beth Lorrell, CSW 718-579-7300 bethlorell@gmail.com | |||||
| Contact: Raman Patel, MD 718-901-8883 rpatel@bronxleb.org | |||||
| Principal Investigator: Raman Patel, MD | |||||
| Principal Investigator: | Delbert Robinson, MD | The North Shore-Long Island Jewish Health System |
More Information
| Responsible Party: | The Zucker Hillside Hospital ( Delbert Robinson, MD / Principal Investigator ) |
| Study ID Numbers: | R01 MH60004-06, DSIR 83-ATAP |
| First Received: | May 1, 2006 |
| Last Updated: | September 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00320671 |
| Health Authority: | United States: Federal Government |
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