Movement Disorders Caused by Antipsychotic Drugs in Older... | NCT00255879

Studies
Movement Disorders Caused by Antipsychotic Drugs in Older Patients

NCT00255879

Sponsor

University of California, San Diego

Status

Completed

Last Update Posted

Jun 6, 2013Estimated

Enrollment

250

Phase

Phase 1

Conditions

Dyskinesia, Drug-Induced

Interventions

Quetiapine
Risperidone
Olanzapine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01MH059101	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1999

Primary Completion Date

Aug 2004Actual

Completion Date

Aug 2004Actual

First Submitted Date

Nov 16, 2005

First Submission Date that Met QC Criteria

Nov 16, 2005

First Posted Date

Nov 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2013

Last Update Posted Date

Jun 6, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dilip V. Jeste, Professor, University of California, San DiegoPrincipal Investigator

Lead Sponsor

University of California, San DiegoOTHER

Collaborators

Name	Class
National Institute of Mental Health (NIMH)	NIH

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dilip V. Jeste, MD	University of California, San Diego	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Diego Division of Geriatric Psychiatry		San Diego	California	92161	United States

Condition Browse Module

MeSH Terms

ID	Term
D004409	Dyskinesia, Drug-Induced
D012559	Schizophrenia
D000071057	Tardive Dyskinesia

Ancestor Terms

ID	Term
D020820	Dyskinesias
D009069	Movement Disorders
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069348	Quetiapine Fumarate
D018967	Risperidone
D000077152	Olanzapine

Ancestor Terms

ID	Term
D003987	Dibenzothiazepines
D013841	Thiazepines
D013846	Thiepins
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Quetiapine	Drug
Risperidone	Drug
Olanzapine	Drug