Side Effects of Newer Antipsychotics in Older Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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Metabolic Effects of Newer Antipsychotics in Older Patients

Conditions
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Schizophrenia, Alzheimer's Disease, Dementia

Intervention / Treatment
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* Drug: Aripiprazole
* Drug: Olanzapine
* Drug: Risperidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV diagnosis of a disease or disorder that requires treatment with an atypical antipsychotic medication Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: Risperdal<br>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. | Drug: Risperidone<br>* Participant will take risperidone. Dosing will be determined by each participant's psychiatrist.<br>* Other names: Risperidal;|
| Experimental: 3: Aripiprazole<br>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. | Drug: Aripiprazole<br>* Participant will take aripiprazole. Dosing will be determined by each participant's psychiatrist.<br>|
| Experimental: 4: Olanzapine<br>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. | Drug: Olanzapine<br>* Participant will take olanzapine. Dosing will be determined by each participant's psychiatrist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Mass Index | 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.) | Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 
| Change in Fasting Plasma Glucose (FPG) | 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.) | Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 
| Change in LDL cholesterol, HDL cholesterol, and triglycerides | 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.) | Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antipsychotic, Diabetes, Hyperlipidemia, Stroke