Recruiting

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

Sponsor:

Neurocrine Biosciences

Code:

NCT03062033

Conditions

Tardive Dyskinesia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Tardive Dyskinesia

Study ID

NCT03062033

Start date

Apr 4, 2017

Status verified date

Nov, 2017

Completion date

Aug, 2018

Anticipated

Primary completion date

Aug, 2018

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

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

Cohort 2

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

Primary outcome measure

Customized clinician-reported outcomes [ Time Frame: 12 months ]
EuroQOL 5 Dimensions EQ-5D-5L) [ Time Frame: 12 months ]
Customized caregiver-reported outcomes: [ Time Frame: 12 months ]
Sheehan Disability Scale (SDS) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Evidera RE-Kinect Registry Team

1-800-242-2196 rekinect@evidera.com

Locations

Neurocrine Clinical Site

Recruiting

Little Rock, Arkansas, United States, 72211

Neurocrine Clinical Site

Recruiting

Anaheim, California, United States, 92804

Neurocrine Clinical Site

Recruiting

Anaheim, California, United States, 92805

Neurocrine Clinical Site

Recruiting

Long Beach, California, United States, 90807

Neurocrine Clinical Site

Recruiting

Los Gatos, California, United States, 95030

Neurocrine Clinical Site

Recruiting

Oceanside, California, United States, 92056

Neurocrine Clinical Site

Recruiting

Gainesville, Florida, United States, 32607

Neurocrine Clinical Site

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Hialeah, Florida, United States, 33018

Neurocrine Clinical Site

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Jacksonville, Florida, United States, 32256

Neurocrine Clinical Site

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Miami Beach, Florida, United States, 33139

Neurocrine Clinical Site

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Miami Springs, Florida, United States, 33166

Neurocrine Clinical Site

Recruiting

Miami, Florida, United States, 33173

Neurocrine Clinical Site

Recruiting

North Miami, Florida, United States, 33161

Neurocrine Clinical Site

Recruiting

Orlando, Florida, United States, 32803

Neurocrine Clinical Site

Recruiting

Tampa, Florida, United States, 33613

Neurocrine Clinical Site

Recruiting

Decatur, Georgia, United States, 30030

Neurocrine Clinical Site

Recruiting

Honolulu, Hawaii, United States, 96817

Neurocrine Clinical Site

Recruiting

Naperville, Illinois, United States, 60563

Neurocrine Clinical Site

Recruiting

Michigan City, Indiana, United States, 46360

Neurocrine Clinical Site

Recruiting

Grand Rapids, Michigan, United States, 49503

Neurocrine Clinical Site

Recruiting

Rochester, Michigan, United States, 48307

Neurocrine Clinical Site

Recruiting

Kansas City, Missouri, United States, 64108

Neurocrine Clinical Site

Recruiting

Saint Louis, Missouri, United States, 63128

Neurocrine Clinical Site

Recruiting

Lincoln, Nebraska, United States, 68526

Neurocrine Clinical Site

Recruiting

Nashua, New Hampshire, United States, 03060

Neurocrine Clinical Site

Recruiting

Durham, North Carolina, United States, 27707

Neurocrine Clinical Site

Recruiting

Hickory, North Carolina, United States, 28601

Neurocrine Clinical Site

Recruiting

Garfield Heights, Ohio, United States, 44125

Neurocrine Clinical Site

Recruiting

Oklahoma City, Oklahoma, United States, 73112

Neurocrine Clinical Site

Recruiting

Houston, Texas, United States, 77030

Neurocrine Clinical Site

Recruiting

Houston, Texas, United States, 77090

Neurocrine Clinical Site

Recruiting

San Antonio, Texas, United States, 78229

Neurocrine Clinical Site

Recruiting

Salt Lake City, Utah, United States, 84105

Neurocrine Clinical Site

Recruiting

Bellevue, Washington, United States, 98007

More Information

Sponsor

Neurocrine Biosciences

Last update posted

Nov 22, 2017

Last verified

Nov, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Neurocrine Biosciences on 2017-11-22.