Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents
RE-Kinect
1 other identifier
observational
70
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2017
34 active sites
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
First Submitted
Initial submission to the registry
February 3, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedStudy Start
First participant enrolled
April 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedNovember 22, 2017
November 1, 2017
1.3 years
February 3, 2017
November 20, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Customized clinician-reported outcomes
Clinician evaluation of patient burden due to tardive dyskinesia symptoms
12 months
EuroQOL 5 Dimensions EQ-5D-5L)
General, single index measure for describing and valuing health-related quality of life.
12 months
Customized caregiver-reported outcomes:
Caregiver evaluation of perceived burden of symptoms on patients as well as the impact on the caregiver
12 months
Sheehan Disability Scale (SDS)
Assessment of functional impairment and disability
12 months
Study Arms (2)
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
Eligibility Criteria
Patients must be 18 years or older with a cumulative lifetime exposure to antipsychotic medication of three months or more.
You may qualify if:
- 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
You may not qualify if:
- Patient is unable to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neurocrine Bioscienceslead
- Evideracollaborator
Study Sites (34)
Neurocrine Clinical Site
Little Rock, Arkansas, 72211, United States
Neurocrine Clinical Site
Anaheim, California, 92804, United States
Neurocrine Clinical Site
Anaheim, California, 92805, United States
Neurocrine Clinical Site
Long Beach, California, 90807, United States
Neurocrine Clinical Site
Los Gatos, California, 95030, United States
Neurocrine Clinical Site
Oceanside, California, 92056, United States
Neurocrine Clinical Site
Gainesville, Florida, 32607, United States
Neurocrine Clinical Site
Hialeah, Florida, 33018, United States
Neurocrine Clinical Site
Jacksonville, Florida, 32256, United States
Neurocrine Clinical Site
Miami, Florida, 33173, United States
Neurocrine Clinical Site
Miami Beach, Florida, 33139, United States
Neurocrine Clinical Site
Miami Springs, Florida, 33166, United States
Neurocrine Clinical Site
North Miami, Florida, 33161, United States
Neurocrine Clinical Site
Orlando, Florida, 32803, United States
Neurocrine Clinical Site
Tampa, Florida, 33613, United States
Neurocrine Clinical Site
Decatur, Georgia, 30030, United States
Neurocrine Clinical Site
Honolulu, Hawaii, 96817, United States
Neurocrine Clinical Site
Naperville, Illinois, 60563, United States
Neurocrine Clinical Site
Michigan City, Indiana, 46360, United States
Neurocrine Clinical Site
Grand Rapids, Michigan, 49503, United States
Neurocrine Clinical Site
Rochester, Michigan, 48307, United States
Neurocrine Clinical Site
Kansas City, Missouri, 64108, United States
Neurocrine Clinical Site
St Louis, Missouri, 63128, United States
Neurocrine Clinical Site
Lincoln, Nebraska, 68526, United States
Neurocrine Clinical Site
Nashua, New Hampshire, 03060, United States
Neurocrine Clinical Site
Durham, North Carolina, 27707, United States
Neurocrine Clinical Site
Hickory, North Carolina, 28601, United States
Neurocrine Clinical Site
Garfield Heights, Ohio, 44125, United States
Neurocrine Clinical Site
Oklahoma City, Oklahoma, 73112, United States
Neurocrine Clinical Site
Houston, Texas, 77030, United States
Neurocrine Clinical Site
Houston, Texas, 77090, United States
Neurocrine Clinical Site
San Antonio, Texas, 78229, United States
Neurocrine Clinical Site
Salt Lake City, Utah, 84105, United States
Neurocrine Clinical Site
Bellevue, Washington, 98007, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chris O'Brien, MD
Chief Medical Officer
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2017
First Posted
February 23, 2017
Study Start
April 4, 2017
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
November 22, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share