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| Sponsor: | Veterans Medical Research Foundation |
|---|---|
| Collaborator: |
National Institute of Mental Health (NIMH) |
| Information provided by: | Veterans Medical Research Foundation |
| ClinicalTrials.gov Identifier: | NCT00245206 |
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 |
| Estimated Enrollment: | 450 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Danielle K. Glorioso, MSW | 858-642-3902 | dkukene@ucsd.edu |
| United States, California | |
| University of California, San Diego | Recruiting |
| San Diego, California, United States, 92037 | |
| Contact: Danielle K. Glorioso, BS 858-642-3902 dkukene@ucsd.edu | |
| Principal Investigator: | Dilip V. Jeste, MD | University of California, San Diego |
More Information
| Responsible Party: | Dilip V. Jeste, UCSD |
| 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: | January 20, 2011 |
| Health Authority: | United States: Federal Government |
|
Antipsychotic Diabetes Hyperlipidemia Stroke |
|
Alzheimer Disease Dementia Schizophrenia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Schizophrenia and Disorders with Psychotic Features Antipsychotic Agents Risperidone Olanzapine Aripiprazole |
Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Dopamine Antagonists Dopamine Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |