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Movement Disorders Caused by Antipsychotic Drugs in Older Patients

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Dilip V. Jeste, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00255879
First received: November 16, 2005
Last updated: June 5, 2013
Last verified: November 2005
History of Changes
  Purpose

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 Intervention Phase
Dyskinesia, Drug-Induced
 Drug: Quetiapine
Drug: Risperidone
Drug: Olanzapine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neuroleptic Induced Movement Disorders in Older Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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
Estimated Enrollment: 250
Study Start Date: January 1999
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility
Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255879

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

No publications provided

Responsible Party: Dilip V. Jeste, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00255879     History of Changes
Other Study ID Numbers: R01 MH59101, R01MH059101
Study First Received: November 16, 2005
Last Updated: June 5, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, San Diego:
Schizophrenia
Neuroleptic
Tardive dyskinesia

Additional relevant MeSH terms:
Dyskinesia, Drug-Induced
Movement Disorders
Central Nervous System Diseases
Chemically-Induced Disorders
Drug-Related Side Effects and Adverse Reactions
 Dyskinesias
Nervous System Diseases
Neurotoxicity Syndromes
Poisoning

ClinicalTrials.gov processed this record on February 27, 2015