Movement Disorders Caused by Antipsychotic Drugs in Older Patients
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| ClinicalTrials.gov Identifier: NCT00255879 |
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Recruitment Status :
Completed
First Posted : November 21, 2005
Last Update Posted : June 6, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dyskinesia, Drug-Induced | Drug: Quetiapine Drug: Risperidone Drug: Olanzapine | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 250 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Neuroleptic Induced Movement Disorders in Older Patients |
| Study Start Date : | January 1999 |
| Actual Primary Completion Date : | August 2004 |
| Actual Study Completion Date : | August 2004 |
- 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
- 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
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- DSM-IV diagnosis of any psychiatric disorder for which an antipsychotic medication is needed
Exclusion Criteria:
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): NCT00255879
| United States, California | |
| University of California, San Diego Division of Geriatric Psychiatry | |
| San Diego, California, United States, 92161 | |
| Principal Investigator: | Dilip V. Jeste, MD | University of California, San Diego |
| Responsible Party: | Dilip V. Jeste, Professor, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT00255879 History of Changes |
| Other Study ID Numbers: |
R01MH059101 ( U.S. NIH Grant/Contract ) R01MH059101 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 21, 2005 Key Record Dates |
| Last Update Posted: | June 6, 2013 |
| Last Verified: | November 2005 |
Keywords provided by Dilip V. Jeste, University of California, San Diego:
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Schizophrenia Neuroleptic Tardive dyskinesia |
Additional relevant MeSH terms:
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Dyskinesias Movement Disorders Dyskinesia, Drug-Induced Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Neurotoxicity Syndromes Drug-Related Side Effects and Adverse Reactions Chemically-Induced Disorders Poisoning Risperidone Olanzapine Quetiapine Fumarate Antipsychotic Agents |
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 |