Movement Disorders Caused by Antipsychotic Drugs in Older Patients
Primary Purpose
Dyskinesia, Drug-Induced
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Quetiapine
Risperidone
Olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for Dyskinesia, Drug-Induced focused on measuring Schizophrenia, Neuroleptic, Tardive dyskinesia
Eligibility Criteria
Inclusion Criteria: DSM-IV diagnosis of any psychiatric disorder for which an antipsychotic medication is needed Exclusion Criteria: N/A
Sites / Locations
- University of California, San Diego Division of Geriatric Psychiatry
Outcomes
Primary Outcome Measures
Extrapyramidal symptoms; measured at Months 1 and 3 and every 3 months for the remainder of the study
Tardive dyskinesia; measured at Months 1 and 3 and every 3 months for the remainder of the study
Secondary Outcome Measures
Everyday functioning; measured at Months 1 and 3 and every 3 months for the remainder of the study
Quality of life; measured at Months 1 and 3 and every 3 months for the remainder of the study
Full Information
NCT ID
NCT00255879
First Posted
November 16, 2005
Last Updated
June 5, 2013
Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00255879
Brief Title
Movement Disorders Caused by Antipsychotic Drugs in Older Patients
Official Title
Neuroleptic Induced Movement Disorders in Older Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief Summary
This study will assess the risk of experiencing tardive dyskinesia and other movement disturbances associated with three atypical antipsychotic drugs among middle-aged and elderly psychiatric patients.
Detailed Description
Use of antipsychotic drugs can result in tardive dyskinesia and extrapyramidal symptoms. Tardive dyskinesia (TD) is a syndrome that causes repetitive, involuntary, purposeless movements in the tongue, lips, or jaw. It can also cause facial grimacing, random movements of arms, legs, fingers, and toes, as well as swaying movements of the trunk or hips. Extrapyramidal symptoms (EPS) include a variety of symptoms, such as involuntary movements, tremors, rigidity, body restlessness, and changes in breathing and heart rate. TD and EPS are side effects of older antipsychotic drugs. Newer antipsychotic drugs, such as quetiapine, olanzapine, and risperidone, do not present as large a risk of developing these side effects. This study will assess the incidence of and risk factors for tardive dyskinesia and extrapyramidal symptoms associated with quetiapine, olanzapine, and risperidone among middle-aged and elderly individuals with psychotic disorders. Additionally, the study will examine the effect of these drugs on symptoms of pre-existing, drug-induced TD. It will also explore the impact of movement disorder symptoms on everyday functioning and quality of life.
Some participants in this open-label study will be randomly assigned to receive quetiapine, olanzapine, or risperidone. Participants who are not randomly assigned to a medication will still receive one of the three medications, based on the decision of their physician. Initial evaluations will be conducted to collect demographic information, as well as medical, psychiatric, and pharmacologic histories. Dosing will be determined by each participant's psychiatrist. All participants will be followed for approximately 5 years. They will report to the study site for outcome assessments at baseline, Months 1 and 3, and every 3 months for the remainder of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyskinesia, Drug-Induced
Keywords
Schizophrenia, Neuroleptic, Tardive dyskinesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Primary Outcome Measure Information:
Title
Extrapyramidal symptoms; measured at Months 1 and 3 and every 3 months for the remainder of the study
Title
Tardive dyskinesia; measured at Months 1 and 3 and every 3 months for the remainder of the study
Secondary Outcome Measure Information:
Title
Everyday functioning; measured at Months 1 and 3 and every 3 months for the remainder of the study
Title
Quality of life; measured at Months 1 and 3 and every 3 months for the remainder of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM-IV diagnosis of any psychiatric disorder for which an antipsychotic medication is needed
Exclusion Criteria:
N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilip V. Jeste, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego Division of Geriatric Psychiatry
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
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Movement Disorders Caused by Antipsychotic Drugs in Older Patients
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