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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00245206 |
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 Drug: Seroquel |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
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1: Experimental
Participants will take risperidal
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Drug: Risperidone
Participant will take risperidone. Dosing will be determined by each participant's psychiatrist.
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2: Experimental
Participants will take seroquel
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Drug: Seroquel
Participant will take seroquel. Dosing will be determined by each participant's psychiatrist.
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3: Experimental
Participants will take aripiprazole
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Drug: Aripiprazole
Participant will take aripiprazole. Dosing will be determined by each participant's psychiatrist.
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4: Experimental
Participants will take olanzapine
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Drug: Olanzapine
Participant will take olanzapine. Dosing will be determined by each participant's psychiatrist.
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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 four atypical antipsychotic medications: aripiprazole; olanzapine; quetiapine; 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.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | UCSD ( Dilip V. Jeste ) |
Study ID Numbers: | R01 MH71536, DATR A5-ETSE |
Study First Received: | October 25, 2005 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00245206 |
Health Authority: | United States: Federal Government |
Antipsychotic Diabetes Hyperlipidemia Stroke |
Hyperlipidemias Cerebral Infarction Alzheimer Disease Stroke Risperidone Olanzapine Diabetes Mellitus Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Serotonin |
Cognition Disorders Schizophrenia Quetiapine Dopamine Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Psychotic Disorders Aripiprazole Dementia Schizophrenia and Disorders with Psychotic Features Delirium |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Tauopathies Central Nervous System Agents |