Movement Disorders Caused by Antipsychotic Drugs in Older Patients

Dyskinesia, Drug-Induced Clinical Trial

Official title:

Neuroleptic Induced Movement Disorders in Older Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255879
• Other study ID #: R01MH059101
• Secondary ID: R01MH059101
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2005
• Last updated: June 5, 2013
• Start date: January 1999
• Est. completion date: August 2004

Study information

• Verified date: November 2005
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyskinesia, Drug-Induced
• Dyskinesias
• Movement Disorders

Intervention

Drug:
• Quetiapine

• Risperidone

• Olanzapine

Locations

Country	Name	City	State
United States	University of California, San Diego Division of Geriatric Psychiatry	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extrapyramidal symptoms; measured at Months 1 and 3 and every 3 months for the remainder of the study
Primary	Tardive dyskinesia; measured at Months 1 and 3 and every 3 months for the remainder of the study
Secondary	Everyday functioning; measured at Months 1 and 3 and every 3 months for the remainder of the study
Secondary	Quality of life; measured at Months 1 and 3 and every 3 months for the remainder of the study