Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255879
Status:
COMPLETED
Last Update Posted:
2013-06-06
First Post:
2005-11-16
Brief Title:
Movement Disorders Caused by Antipsychotic Drugs in Older Patients
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Neuroleptic Induced Movement Disorders in Older Patients
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 participants 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
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 participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH059101 | NIH | None | httpsreporternihgovquickSearchR01MH059101 |