NCT00245206

Side Effects of Newer Antipsychotics in Older Adults

Metabolic Effects of Newer Antipsychotics in Older Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 406 (actual)
• Sponsor: Veterans Medical Research Foundation · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Schizophrenia
• Alzheimer's Disease
• Dementia

Interventions

Type	Name	Description
DRUG	Aripiprazole	Participant will take aripiprazole. Dosing will be determined by each participant's psychiatrist.
DRUG	Olanzapine	Participant will take olanzapine. Dosing will be determined by each participant's psychiatrist.
DRUG	Risperidone	Participant will take risperidone. Dosing will be determined by each participant's psychiatrist.

Timeline

• Start date: 2005-08-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2005-10-27
• Last updated: 2018-12-17

Locations

1 site across 1 country: United States