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| Descriptive Information Fields | |||||
| Brief Title † | Side Effects of Newer Antipsychotics in Older Adults | ||||
| Official Title † | Metabolic Effects of Newer Antipsychotics in Older Patients | ||||
| Brief Summary | This study will compare four atypical antipsychotic medications in terms of the risk of specific side effects each of them presents in middle-aged and elderly individuals. |
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| Detailed Description | Atypical antipsychotic medications introduced within the last decade have been used increasingly for the treatment of several types of psychotic disorders and severe behavioral disturbances in older individuals. This trend is primarily due to a decrease in side effects caused by the new medications, as compared to conventional neuroleptic medications. There is a lower risk for developing tardive dyskinesia and extrapyramidal symptoms, both of which are movement abnormalities, with new antipsychotic medications. However, there has been a growing concern that the newer medications can cause a different set of potentially serious adverse side effects. Specifically, they may cause long-term metabolic, cardiovascular, and cerebrovascular effects, which may result in weight gain, diabetes, or stroke. This study will compare four atypical antipsychotic medications in terms of the risk of metabolic, cardiovascular, and cerebrovascular side effects that each presents in middle-aged and elderly individuals. Participants in this open-label study will be randomly assigned to receive one of four atypical antipsychotic medications: aripiprazole; olanzapine; quetiapine; or risperidone. Although assignment is random, a technique that may reflect the participant's own interests or the researcher's knowledge of relevant participant characteristics will be used to assign the participant to a medication. Dosing will be determined by each participant's psychiatrist. Participants will be followed for up to 5 years to assess the side effects of the study medications, with study visits at baseline, Week 6, and every 3 months thereafter. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Metabolic, cardiovascular, and cerebrovascular effects [ Time Frame: Measured at baseline, Week 6, and every 3 months for the remainder of the study ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Schizophrenia Alzheimer's Disease Dementia |
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| Intervention † | Drug: Aripiprazole Drug: Olanzapine Drug: Risperidone Drug: Seroquel |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 450 | ||||
| Start Date † | August 2005 | ||||
| Completion Date | June 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 45 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00245206 | ||||
| Organization ID | R01 MH71536 | ||||
| Secondary IDs †† | DATR A5-ETSE | ||||
| 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 | March 2008 | ||||
| First Received Date † | October 25, 2005 | ||||
| Last Updated Date | March 27, 2008 | ||||