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

Tardive Dyskinesia Clinical Trial

— RE-Kinect  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03062033
• Other study ID #: EVA-19350
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2017
• Last updated: November 20, 2017
• Start date: April 4, 2017
• Est. completion date: August 2018

Study information

• Verified date: November 2017
• Source: Neurocrine Biosciences
• Contact: Evidera RE-Kinect Registry Team
• Phone: 1-800-242-2196
• Email: rekinect[@]evidera.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyskinesias
• Tardive Dyskinesia

Locations

Country	Name	City	State
United States	Neurocrine Clinical Site	Anaheim	California
United States	Neurocrine Clinical Site	Anaheim	California
United States	Neurocrine Clinical Site	Bellevue	Washington
United States	Neurocrine Clinical Site	Decatur	Georgia
United States	Neurocrine Clinical Site	Durham	North Carolina
United States	Neurocrine Clinical Site	Gainesville	Florida
United States	Neurocrine Clinical Site	Garfield Heights	Ohio
United States	Neurocrine Clinical Site	Grand Rapids	Michigan
United States	Neurocrine Clinical Site	Hialeah	Florida
United States	Neurocrine Clinical Site	Hickory	North Carolina
United States	Neurocrine Clinical Site	Honolulu	Hawaii
United States	Neurocrine Clinical Site	Houston	Texas
United States	Neurocrine Clinical Site	Houston	Texas
United States	Neurocrine Clinical Site	Jacksonville	Florida
United States	Neurocrine Clinical Site	Kansas City	Missouri
United States	Neurocrine Clinical Site	Lincoln	Nebraska
United States	Neurocrine Clinical Site	Little Rock	Arkansas
United States	Neurocrine Clinical Site	Long Beach	California
United States	Neurocrine Clinical Site	Los Gatos	California
United States	Neurocrine Clinical Site	Miami	Florida
United States	Neurocrine Clinical Site	Miami Beach	Florida
United States	Neurocrine Clinical Site	Miami Springs	Florida
United States	Neurocrine Clinical Site	Michigan City	Indiana
United States	Neurocrine Clinical Site	Naperville	Illinois
United States	Neurocrine Clinical Site	Nashua	New Hampshire
United States	Neurocrine Clinical Site	North Miami	Florida
United States	Neurocrine Clinical Site	Oceanside	California
United States	Neurocrine Clinical Site	Oklahoma City	Oklahoma
United States	Neurocrine Clinical Site	Orlando	Florida
United States	Neurocrine Clinical Site	Rochester	Michigan
United States	Neurocrine Clinical Site	Saint Louis	Missouri
United States	Neurocrine Clinical Site	Salt Lake City	Utah
United States	Neurocrine Clinical Site	San Antonio	Texas
United States	Neurocrine Clinical Site	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Neurocrine Biosciences	Evidera

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Customized clinician-reported outcomes	Clinician evaluation of patient burden due to tardive dyskinesia symptoms	12 months
Primary	EuroQOL 5 Dimensions EQ-5D-5L)	General, single index measure for describing and valuing health-related quality of life.	12 months
Primary	Customized caregiver-reported outcomes:	Caregiver evaluation of perceived burden of symptoms on patients as well as the impact on the caregiver	12 months
Primary	Sheehan Disability Scale (SDS)	Assessment of functional impairment and disability	12 months