Side Effects of Newer Antipsychotics in Older Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dilip V. Jeste, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00245206
First received: October 25, 2005
Last updated: June 11, 2013
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Alzheimer's Disease
Dementia
Drug: Aripiprazole
Drug: Olanzapine
Drug: Risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metabolic Effects of Newer Antipsychotics in Older Patients

Resource links provided by NLM:


Further study details as provided by Veterans Medical Research Foundation:

Primary Outcome Measures:
  • 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 ]

Enrollment: 406
Study Start Date: August 2005
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will take risperidal
Drug: Risperidone
Participant will take risperidone. Dosing will be determined by each participant's psychiatrist.
Other Name: Risperidal
Experimental: 3
Participants will take aripiprazole
Drug: Aripiprazole
Participant will take aripiprazole. Dosing will be determined by each participant's psychiatrist.
Experimental: 4
Participants will take olanzapine
Drug: Olanzapine
Participant will take olanzapine. Dosing will be determined by each participant's psychiatrist.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245206

Locations
United States, California
University of California, San Diego
San Diego, California, United States, 92037
Sponsors and Collaborators
Veterans Medical Research Foundation
Investigators
Principal Investigator: Dilip V. Jeste, MD University of California, San Diego
  More Information

No publications provided by Veterans Medical Research Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dilip V. Jeste, Psychiatry, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00245206     History of Changes
Other Study ID Numbers: R01 MH071536, DATR A5-ETSE, R01MH071536
Study First Received: October 25, 2005
Last Updated: June 11, 2013
Health Authority: United States: Federal Government

Keywords provided by Veterans Medical Research Foundation:
Antipsychotic
Diabetes
Hyperlipidemia
Stroke

Additional relevant MeSH terms:
Alzheimer Disease
Schizophrenia
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Schizophrenia and Disorders with Psychotic Features
Tauopathies
Antipsychotic Agents
Aripiprazole
Olanzapine
Risperidone
Antiemetics
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents

ClinicalTrials.gov processed this record on October 20, 2014