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Movement Disorders Caused by Antipsychotic Drugs in Older Patients

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ClinicalTrials.gov Identifier: NCT00255879
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : June 6, 2013
Information provided by (Responsible Party):

Study Description
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

Study Type : Interventional  (Clinical Trial)
Estimated 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
Primary Completion Date : August 2004
Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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:

Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
University of California, San Diego
National Institute of Mental Health (NIMH)
Principal Investigator: Dilip V. Jeste, MD University of California, San Diego
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    Key Record Dates
Last Update Posted: June 6, 2013
Last Verified: November 2005

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

Additional relevant MeSH terms:
Dyskinesia, Drug-Induced
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Neurotoxicity Syndromes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
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
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors