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Side Effects of Newer Antipsychotics in Older Adults
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), April 2009
First Received: October 25, 2005   Last Updated: April 10, 2009   History of Changes
Sponsor: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
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 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

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Metabolic, cardiovascular, and cerebrovascular effects [ Time Frame: Measured at baseline, Week 6, and every 3 months for the remainder of the study ] [ Designated as safety issue: Yes ]

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
1: Experimental
Participants will take risperidal
Drug: Risperidone
Participant will take risperidone. Dosing will be determined by each participant's psychiatrist.
3: Experimental
Participants will take aripiprazole
Drug: Aripiprazole
Participant will take aripiprazole. Dosing will be determined by each participant's psychiatrist.
4: Experimental
Participants will take olanzapine
Drug: Olanzapine
Participant will take olanzapine. Dosing will be determined by each participant's psychiatrist.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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:

  • N/A
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245206

Contacts
Contact: Danielle K. Glorioso, MSW 858-642-3902 dkukene@ucsd.edu

Locations
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    
Sponsors and Collaborators
Investigators
Principal Investigator: Dilip V. Jeste, MD University of California, San Diego
  More Information

No publications provided

Responsible Party: UCSD ( Dilip V. Jeste )
Study ID Numbers: R01 MH071536, DATR A5-ETSE
Study First Received: October 25, 2005
Last Updated: April 10, 2009
ClinicalTrials.gov Identifier: NCT00245206     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Antipsychotic
Diabetes
Hyperlipidemia
Stroke

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Neurodegenerative Diseases
Brain Diseases
Schizophrenia
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Aripiprazole
Dementia
Schizophrenia and Disorders with Psychotic Features
Tranquilizing Agents
Nervous System Diseases
Alzheimer Disease
Gastrointestinal Agents
Risperidone
Central Nervous System Diseases
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Delirium, Dementia, Amnestic, Cognitive Disorders
Serotonin Agents
Autonomic Agents

ClinicalTrials.gov processed this record on November 05, 2009