Movement Disorders Caused by Antipsychotic Drugs in Older Patients

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Dyskinesia, Drug-Induced	Drug: Quetiapine; Drug: Risperidone; Drug: Olanzapine	Phase 1

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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

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Locations

United States, California
University of California, San Diego Division of Geriatric Psychiatry
San Diego, California, United States, 92161

Sponsors and Collaborators

University of California, San Diego

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Dilip V. Jeste, MD	University of California, San Diego

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 )
First Posted:	November 21, 2005
Last Update Posted:	June 6, 2013
Last Verified:	November 2005

Keywords provided by Dilip V. Jeste, University of California, San Diego:

Schizophrenia; Neuroleptic; Tardive dyskinesia

Additional relevant MeSH terms:

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