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Side Effects of Newer Antipsychotics in Older Adults

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00245206
First received: October 25, 2005
Last updated: October 17, 2012
Last verified: April 2009
History of Changes

October 25, 2005
October 17, 2012
August 2005
October 2010   (final data collection date for 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 ]
Metabolic, cardiovascular, and cerebrovascular effects; measured at baseline, Week 6, and every 3 months for the remainder of the study
Complete list of historical versions of study NCT00245206 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Side Effects of Newer Antipsychotics in Older Adults
Metabolic Effects of Newer Antipsychotics in Older Patients

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Alzheimer's Disease
  • Dementia
  • 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.
    Other Name: Risperidal
  • Experimental: 1
    Participants will take risperidal
    Intervention: Drug: Risperidone
  • Experimental: 3
    Participants will take aripiprazole
    Intervention: Drug: Aripiprazole
  • Experimental: 4
    Participants will take olanzapine
    Intervention: Drug: Olanzapine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
406
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
Both
40 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00245206
R01 MH071536, DATR A5-ETSE, R01MH071536
Yes
Veterans Medical Research Foundation
Veterans Medical Research Foundation
National Institute of Mental Health (NIMH)
Principal Investigator: Dilip V. Jeste, MD University of California, San Diego
Veterans Medical Research Foundation
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP