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Side Effects of Newer Antipsychotics in Older Adults

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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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.

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.

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
Intervention  Drug: Aripiprazole
Drug: Olanzapine
Drug: Risperidone
Drug: Seroquel
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  450
Start Date  August 2005
Completion Date June 2010
Eligibility Criteria 

Inclusion Criteria:

  • DSM-IV diagnosis of a disease or disorder that requires treatment with an atypical antipsychotic medication

Exclusion Criteria:

  • N/A
Gender Both
Ages 45 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Danielle K. Glorioso, BS     858-642-3902     dkukene@ucsd.edu    
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 
Principal Investigator:     Dilip V. Jeste, MD     University of California, San Diego    
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

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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