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Trial record 1 of 1 for:    NCT03062033
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Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents (RE-Kinect)

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ClinicalTrials.gov Identifier: NCT03062033
Recruitment Status : Unknown
Verified November 2017 by Neurocrine Biosciences.
Recruitment status was:  Recruiting
First Posted : February 23, 2017
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
Evidera
Information provided by (Responsible Party):
Neurocrine Biosciences

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.

Condition or disease
Tardive Dyskinesia

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Group/Cohort
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 Measures :
  1. Customized clinician-reported outcomes [ Time Frame: 12 months ]
    Clinician evaluation of patient burden due to tardive dyskinesia symptoms

  2. EuroQOL 5 Dimensions EQ-5D-5L) [ Time Frame: 12 months ]
    General, single index measure for describing and valuing health-related quality of life.

  3. Customized caregiver-reported outcomes: [ Time Frame: 12 months ]
    Caregiver evaluation of perceived burden of symptoms on patients as well as the impact on the caregiver

  4. Sheehan Disability Scale (SDS) [ Time Frame: 12 months ]
    Assessment of functional impairment and disability



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients must be 18 years or older with a cumulative lifetime exposure to antipsychotic medication of three months or more.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062033


Contacts
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Contact: Evidera RE-Kinect Registry Team 1-800-242-2196 rekinect@evidera.com

Locations
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United States, Arkansas
Neurocrine Clinical Site Recruiting
Little Rock, Arkansas, United States, 72211
United States, California
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
United States, Florida
Neurocrine Clinical Site Recruiting
Gainesville, Florida, United States, 32607
Neurocrine Clinical Site Recruiting
Hialeah, Florida, United States, 33018
Neurocrine Clinical Site Recruiting
Jacksonville, Florida, United States, 32256
Neurocrine Clinical Site Recruiting
Miami Beach, Florida, United States, 33139
Neurocrine Clinical Site Recruiting
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
United States, Georgia
Neurocrine Clinical Site Recruiting
Decatur, Georgia, United States, 30030
United States, Hawaii
Neurocrine Clinical Site Recruiting
Honolulu, Hawaii, United States, 96817
United States, Illinois
Neurocrine Clinical Site Recruiting
Naperville, Illinois, United States, 60563
United States, Indiana
Neurocrine Clinical Site Recruiting
Michigan City, Indiana, United States, 46360
United States, Michigan
Neurocrine Clinical Site Recruiting
Grand Rapids, Michigan, United States, 49503
Neurocrine Clinical Site Recruiting
Rochester, Michigan, United States, 48307
United States, Missouri
Neurocrine Clinical Site Recruiting
Kansas City, Missouri, United States, 64108
Neurocrine Clinical Site Recruiting
Saint Louis, Missouri, United States, 63128
United States, Nebraska
Neurocrine Clinical Site Recruiting
Lincoln, Nebraska, United States, 68526
United States, New Hampshire
Neurocrine Clinical Site Recruiting
Nashua, New Hampshire, United States, 03060
United States, North Carolina
Neurocrine Clinical Site Recruiting
Durham, North Carolina, United States, 27707
Neurocrine Clinical Site Recruiting
Hickory, North Carolina, United States, 28601
United States, Ohio
Neurocrine Clinical Site Recruiting
Garfield Heights, Ohio, United States, 44125
United States, Oklahoma
Neurocrine Clinical Site Recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Texas
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
United States, Utah
Neurocrine Clinical Site Recruiting
Salt Lake City, Utah, United States, 84105
United States, Washington
Neurocrine Clinical Site Recruiting
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Neurocrine Biosciences
Evidera
Investigators
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Study Director: Chris O'Brien, MD Chief Medical Officer
Additional Information:

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Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT03062033    
Other Study ID Numbers: EVA-19350
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dyskinesias
Tardive Dyskinesia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Dyskinesia, Drug-Induced