Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents (RE-Kinect)

November 20, 2017 updated by: Neurocrine Biosciences
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Neurocrine Clinical Site
    • California
      • Anaheim, California, United States, 92804
        • Recruiting
        • Neurocrine Clinical Site
      • Anaheim, California, United States, 92805
        • Recruiting
        • Neurocrine Clinical Site
      • Long Beach, California, United States, 90807
        • Recruiting
        • Neurocrine Clinical Site
      • Los Gatos, California, United States, 95030
        • Recruiting
        • Neurocrine Clinical Site
      • Oceanside, California, United States, 92056
        • Recruiting
        • Neurocrine Clinical Site
    • Florida
      • Gainesville, Florida, United States, 32607
        • Recruiting
        • Neurocrine Clinical Site
      • Hialeah, Florida, United States, 33018
        • Recruiting
        • Neurocrine Clinical Site
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Neurocrine Clinical Site
      • Miami, Florida, United States, 33173
        • Recruiting
        • Neurocrine Clinical Site
      • Miami Beach, Florida, United States, 33139
        • Recruiting
        • Neurocrine Clinical Site
      • Miami Springs, Florida, United States, 33166
        • Recruiting
        • Neurocrine Clinical Site
      • North Miami, Florida, United States, 33161
        • Recruiting
        • Neurocrine Clinical Site
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Neurocrine Clinical Site
      • Tampa, Florida, United States, 33613
        • Recruiting
        • Neurocrine Clinical Site
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Neurocrine Clinical Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Neurocrine Clinical Site
    • Illinois
      • Naperville, Illinois, United States, 60563
        • Recruiting
        • Neurocrine Clinical Site
    • Indiana
      • Michigan City, Indiana, United States, 46360
        • Recruiting
        • Neurocrine Clinical Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Neurocrine Clinical Site
      • Rochester, Michigan, United States, 48307
        • Recruiting
        • Neurocrine Clinical Site
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Neurocrine Clinical Site
      • Saint Louis, Missouri, United States, 63128
        • Recruiting
        • Neurocrine Clinical Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Recruiting
        • Neurocrine Clinical Site
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Recruiting
        • Neurocrine Clinical Site
    • North Carolina
      • Durham, North Carolina, United States, 27707
        • Recruiting
        • Neurocrine Clinical Site
      • Hickory, North Carolina, United States, 28601
        • Recruiting
        • Neurocrine Clinical Site
    • Ohio
      • Garfield Heights, Ohio, United States, 44125
        • Recruiting
        • Neurocrine Clinical Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Neurocrine Clinical Site
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Neurocrine Clinical Site
      • Houston, Texas, United States, 77090
        • Recruiting
        • Neurocrine Clinical Site
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Neurocrine Clinical Site
    • Utah
      • Salt Lake City, Utah, United States, 84105
        • Recruiting
        • Neurocrine Clinical Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Neurocrine Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Customized clinician-reported outcomes
Time Frame: 12 months
Clinician evaluation of patient burden due to tardive dyskinesia symptoms
12 months
EuroQOL 5 Dimensions EQ-5D-5L)
Time Frame: 12 months
General, single index measure for describing and valuing health-related quality of life.
12 months
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
12 months
Sheehan Disability Scale (SDS)
Time Frame: 12 months
Assessment of functional impairment and disability
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurocrine Biosciences

Collaborators

Evidera

Investigators

  • Study Director: Chris O'Brien, MD, Chief Medical Officer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2017

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

February 3, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

November 22, 2017

Last Update Submitted That Met QC Criteria

November 20, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVA-19350

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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