Side Effects of Newer Antipsychotics in Older Adults
|ClinicalTrials.gov Identifier: NCT00245206|
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : June 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Alzheimer's Disease Dementia||Drug: Aripiprazole Drug: Olanzapine Drug: Risperidone||Phase 4|
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 three atypical antipsychotic medications: aripiprazole; olanzapine; 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||406 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metabolic Effects of Newer Antipsychotics in Older Patients|
|Study Start Date :||August 2005|
|Primary Completion Date :||October 2010|
|Study Completion Date :||October 2010|
Participants will take risperidal
Participant will take risperidone. Dosing will be determined by each participant's psychiatrist.
Other Name: Risperidal
Participants will take aripiprazole
Participant will take aripiprazole. Dosing will be determined by each participant's psychiatrist.
Participants will take olanzapine
Participant will take olanzapine. Dosing will be determined by each participant's psychiatrist.
- Metabolic, cardiovascular, and cerebrovascular effects [ Time Frame: Measured at baseline, Week 6, and every 3 months for the remainder of the study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245206
|United States, California|
|University of California, San Diego|
|San Diego, California, United States, 92037|
|Principal Investigator:||Dilip V. Jeste, MD||University of California, San Diego|