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Completed

NCT Number: NCT00255879

Movement Disorders Caused by Antipsychotic Drugs in Older Patients

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.

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Key information

Conditions

Dyskinesia, Drug-Induced Central Nervous System Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Dyskinesias Mental Disorders Movement Disorders Nervous System Diseases Neurologic Manifestations Neurotoxicity Syndromes Pathological Conditions, Signs and Symptoms Poisoning Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms Tardive Dyskinesia

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, San Diego Division of Geriatric Psychiatry

San Diego, California, 92161, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • DSM-IV diagnosis of any psychiatric disorder for which an antipsychotic medication is needed

Exclusion criteria

  • N/A

Treatment and study plan

Quetiapine

Drug

Risperidone

Drug

Olanzapine

Drug

Primary outcomes

  1. Extrapyramidal symptoms; measured at Months 1 and 3 and every 3 months for the remainder of the study

  2. Tardive dyskinesia; measured at Months 1 and 3 and every 3 months for the remainder of the study

Secondary outcomes

  1. Everyday functioning; measured at Months 1 and 3 and every 3 months for the remainder of the study

  2. Quality of life; measured at Months 1 and 3 and every 3 months for the remainder of the study

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Neuroleptic Induced Movement Disorders in Older Patients

Important dates

Study start
1999
Primary completion
2004
Study completion
2004
First posted
Nov 21, 2005
Registry last updated
Jun 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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