Dyskinesia, Drug-Induced
Conditions
Keywords
Schizophrenia, Neuroleptic, Tardive dyskinesia
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.
Interventions
DRUGQuetiapine
DRUGRisperidone
DRUGOlanzapine
Sponsors
National Institute of Mental Health (NIMH)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* DSM-IV diagnosis of any psychiatric disorder for which an antipsychotic medication is needed
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed