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| Descriptive Information Fields | |||||||||
| Brief Title † | Comparison of Aripiprazole and Risperidone for the Treatment of People With First-Episode Psychosis | ||||||||
| Official Title † | Preventing Morbidity in First Episode Schizophrenia, Part II | ||||||||
| Brief Summary | This study will evaluate the effectiveness of aripiprazole versus risperidone in treating people with first-episode schizophrenia. |
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| Detailed Description | 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. |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Treatment response [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ] Patterns of change in weight and body mass index (BMI) [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ] Incidence rates of metabolic syndrome and new-onset diabetes [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Negative symptoms [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ] Cognition [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ] Quality of life [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ] Adverse events other than metabolic [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ] Substance use [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ] |
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| Condition † | Schizophrenia | ||||||||
| Intervention † | Drug: Aripiprazole Drug: Risperidone |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 242 | ||||||||
| Start Date † | December 2005 | ||||||||
| Completion Date | July 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 15 Years to 40 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00320671 | ||||||||
| Organization ID | R01 MH60004-06 | ||||||||
| Secondary IDs †† | DSIR 83-ATAP | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | September 2008 | ||||||||
| First Received Date † | May 1, 2006 | ||||||||
| Last Updated Date | September 8, 2008 | ||||||||
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