Side Effects of Newer Antipsychotics in Older Adults
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| ClinicalTrials.gov Identifier: NCT00245206 |
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Recruitment Status :
Completed
First Posted : October 27, 2005
Last Update Posted : December 17, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia Alzheimer's Disease Dementia | Drug: Aripiprazole Drug: Olanzapine Drug: Risperidone | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 406 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Metabolic Effects of Newer Antipsychotics in Older Patients |
| Study Start Date : | August 2005 |
| Actual Primary Completion Date : | October 2010 |
| Actual Study Completion Date : | October 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1: Risperdal
Participants randomized to this arm will be prescribed risperdal. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff.
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Drug: Risperidone
Participant will take risperidone. Dosing will be determined by each participant's psychiatrist.
Other Name: Risperidal |
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Experimental: 3: Aripiprazole
Participants randomized to this arm will be prescribed aripiprazole. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff.
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Drug: Aripiprazole
Participant will take aripiprazole. Dosing will be determined by each participant's psychiatrist. |
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Experimental: 4: Olanzapine
Participants randomized to this arm will be prescribed olanzapine. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff.
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Drug: Olanzapine
Participant will take olanzapine. Dosing will be determined by each participant's psychiatrist. |
- Change in Body Mass Index [ Time Frame: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]Change in body mass index (BMI) between each study visit. weight and height will be combined to report BMI in kg/m^2. (This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)
- Change in Fasting Plasma Glucose (FPG) [ Time Frame: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]Blood sample collected to measure Fasting Plasma Glucose (FPG) to determine if there are changes between study visits. (This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)
- Change in LDL cholesterol, HDL cholesterol, and triglycerides [ Time Frame: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ]Lipid Panel collected to measure LDL cholesterol, HDL cholesterol, and triglycerides and determine if there are changes between study visits. (This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- DSM-IV diagnosis of a disease or disorder that requires treatment with an atypical antipsychotic medication
Exclusion Criteria:
- N/A
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
| United States, California | |
| University of California, San Diego | |
| San Diego, California, United States, 92037 | |
| Principal Investigator: | Dilip V. Jeste, MD | University of California, San Diego |
| Responsible Party: | Dilip V. Jeste, Psychiatry, Veterans Medical Research Foundation |
| ClinicalTrials.gov Identifier: | NCT00245206 |
| Other Study ID Numbers: |
R01MH071536 ( U.S. NIH Grant/Contract ) DATR A5-ETSE ( Registry Identifier: Clinicaltrials.gov ) R01MH071536 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 27, 2005 Key Record Dates |
| Last Update Posted: | December 17, 2018 |
| Last Verified: | December 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Antipsychotic Diabetes Hyperlipidemia Stroke |
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Alzheimer Disease Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Olanzapine Risperidone Aripiprazole Serotonin Antagonists |
Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Serotonin Uptake Inhibitors |