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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Neurocrine Biosciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Evidera

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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