Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents

NCT ID: NCT03062033

Last Updated: 2017-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-04

Study Completion Date

2018-08-31

Brief Summary

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Prospective study to quantify the prevalence of possible tardive dyskinesia (TD) in outpatient psychiatry practices in the United States (US), as well as to describe the associated disease burden in a cohort of patients with one or more psychiatric disorders and a cumulative lifetime exposure to antipsychotic medication of three months or more.

Detailed Description

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Conditions

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Tardive Dyskinesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Patients without visible signs of involuntary movements (possible TD) at time of clinician assessment

No interventions assigned to this group

Cohort 2

Patients with visible signs of involuntary movements (possible TD) at the time of clinician assessment

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patient has a cumulative lifetime exposure to antipsychotic medication of three months or more
* Patient has a clinician confirmed diagnosis of one or more psychiatric disorder(s), as defined in the DSM-5
* Patient has a usual care clinic visit scheduled during the study recruitment window (i.e. a pre-defined 2-week period)
* Patient is able to read and understand English
* Patient is willing and able to comply with the study requirements

Exclusion Criteria

* Patient is unable to provide informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Evidera

INDUSTRY

Sponsor Role collaborator

Neurocrine Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris O'Brien, MD

Role: STUDY_DIRECTOR

Chief Medical Officer

Locations

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Neurocrine Clinical Site

Little Rock, Arkansas, United States

Site Status RECRUITING

Neurocrine Clinical Site

Anaheim, California, United States

Site Status RECRUITING

Neurocrine Clinical Site

Anaheim, California, United States

Site Status RECRUITING

Neurocrine Clinical Site

Long Beach, California, United States

Site Status RECRUITING

Neurocrine Clinical Site

Los Gatos, California, United States

Site Status RECRUITING

Neurocrine Clinical Site

Oceanside, California, United States

Site Status RECRUITING

Neurocrine Clinical Site

Gainesville, Florida, United States

Site Status RECRUITING

Neurocrine Clinical Site

Hialeah, Florida, United States

Site Status RECRUITING

Neurocrine Clinical Site

Jacksonville, Florida, United States

Site Status RECRUITING

Neurocrine Clinical Site

Miami, Florida, United States

Site Status RECRUITING

Neurocrine Clinical Site

Miami Beach, Florida, United States

Site Status RECRUITING

Neurocrine Clinical Site

Miami Springs, Florida, United States

Site Status RECRUITING

Neurocrine Clinical Site

North Miami, Florida, United States

Site Status RECRUITING

Neurocrine Clinical Site

Orlando, Florida, United States

Site Status RECRUITING

Neurocrine Clinical Site

Tampa, Florida, United States

Site Status RECRUITING

Neurocrine Clinical Site

Decatur, Georgia, United States

Site Status RECRUITING

Neurocrine Clinical Site

Honolulu, Hawaii, United States

Site Status RECRUITING

Neurocrine Clinical Site

Naperville, Illinois, United States

Site Status RECRUITING

Neurocrine Clinical Site

Michigan City, Indiana, United States

Site Status RECRUITING

Neurocrine Clinical Site

Grand Rapids, Michigan, United States

Site Status RECRUITING

Neurocrine Clinical Site

Rochester, Michigan, United States

Site Status RECRUITING

Neurocrine Clinical Site

Kansas City, Missouri, United States

Site Status RECRUITING

Neurocrine Clinical Site

St Louis, Missouri, United States

Site Status RECRUITING

Neurocrine Clinical Site

Lincoln, Nebraska, United States

Site Status RECRUITING

Neurocrine Clinical Site

Nashua, New Hampshire, United States

Site Status RECRUITING

Neurocrine Clinical Site

Durham, North Carolina, United States

Site Status RECRUITING

Neurocrine Clinical Site

Hickory, North Carolina, United States

Site Status RECRUITING

Neurocrine Clinical Site

Garfield Heights, Ohio, United States

Site Status RECRUITING

Neurocrine Clinical Site

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Neurocrine Clinical Site

Houston, Texas, United States

Site Status RECRUITING

Neurocrine Clinical Site

Houston, Texas, United States

Site Status RECRUITING

Neurocrine Clinical Site

San Antonio, Texas, United States

Site Status RECRUITING

Neurocrine Clinical Site

Salt Lake City, Utah, United States

Site Status RECRUITING

Neurocrine Clinical Site

Bellevue, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Evidera RE-Kinect Registry Team

Role: CONTACT

Phone: 1-800-242-2196

Email: [email protected]

Other Identifiers

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EVA-19350

Identifier Type: -

Identifier Source: org_study_id