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Side Effects of Newer Antipsychotics in Older Adults

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ClinicalTrials.gov Identifier: NCT00245206
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : December 17, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Dilip V. Jeste, Veterans Medical Research Foundation

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Alzheimer's Disease Dementia Drug: Aripiprazole Drug: Olanzapine Drug: Risperidone Phase 4

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.


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
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.
Drug: Risperidone
Participant will take risperidone. Dosing will be determined by each participant's psychiatrist.
Other Name: Risperidal

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.
Drug: Aripiprazole
Participant will take aripiprazole. Dosing will be determined by each participant's psychiatrist.

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.
Drug: Olanzapine
Participant will take olanzapine. Dosing will be determined by each participant's psychiatrist.




Primary Outcome Measures :
  1. 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.)

  2. 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.)

  3. 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
Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of a disease or disorder that requires treatment with an atypical antipsychotic medication

Exclusion Criteria:


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

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 ( 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

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