NCT00255879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 1999

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
Last Updated

June 6, 2013

Status Verified

November 1, 2005

Enrollment Period

5.6 years

First QC Date

November 16, 2005

Last Update Submit

June 5, 2013

Conditions

Dyskinesia, Drug-Induced

Keywords

SchizophreniaNeurolepticTardive dyskinesia

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • 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

Interventions

QuetiapineDRUG
RisperidoneDRUG
OlanzapineDRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego Division of Geriatric Psychiatry

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Dyskinesia, Drug-InducedSchizophreniaTardive Dyskinesia

Interventions

Quetiapine FumarateRisperidoneOlanzapine

Condition Hierarchy (Ancestors)

DyskinesiasMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsNeurotoxicity SyndromesSigns and SymptomsPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoningSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-Ring

Study Officials

  • Dilip V. Jeste, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 16, 2005

First Posted

November 21, 2005

Study Start

January 1, 1999

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

June 6, 2013

Record last verified: 2005-11

Locations

US(1)