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Trial record 1 of 1 for:    NCT00245206
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Side Effects of Newer Antipsychotics in Older Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00245206
First Posted: October 27, 2005
Last Update Posted: June 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Dilip V. Jeste, Veterans Medical Research Foundation
  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
Intervention Model: Parallel Assignment
Masking: None (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 Dilip V. Jeste, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245206


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

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: R01MH071536 ( U.S. NIH Grant/Contract )
DATR A5-ETSE
First Submitted: October 25, 2005
First Posted: October 27, 2005
Last Update Posted: June 12, 2013
Last Verified: April 2009

Keywords provided by Dilip V. Jeste, Veterans Medical Research Foundation:
Antipsychotic
Diabetes
Hyperlipidemia
Stroke

Additional relevant MeSH terms:
Schizophrenia
Alzheimer Disease
Dementia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Risperidone
Antipsychotic Agents
Aripiprazole
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors