Movement Disorders Caused by Antipsychotic Drugs in Older Patients

NCT ID: NCT00255879

Last Updated: 2013-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-01-31
• Study Completion Date: 2004-08-31

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.

Conditions

Dyskinesia, Drug-Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Quetiapine

Intervention Type: DRUG

Risperidone

Intervention Type: DRUG

Olanzapine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• N/A

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Dilip V. Jeste

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dilip V. Jeste, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California, San Diego Division of Geriatric Psychiatry

San Diego, California, United States

Countries

United States

Other Identifiers

R01MH059101

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH059101

Identifier Type: NIH

Identifier Source: org_study_id

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