Tardive DyskinesiaRE-KinectNCT03062033
Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents
An observational study of Tardive Dyskinesia, run by Neurocrine Biosciences at 34 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tardive Dyskinesia
- How many people
- 70 participants
- Where
- 34 sitesUnited States
- Study dates
- 4 Apr 2017to Aug 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients must be 18 years or older with a cumulative lifetime exposure to antipsychotic medication of three months or more.
Who may be able to join
- 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
Who cannot join
- Patient is unable to provide informed consent.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites, 34 recruiting
- Recruiting
Neurocrine Clinical Site
Anaheim, California, 92804
- Recruiting
Neurocrine Clinical Site
Anaheim, California, 92805
- Recruiting
Neurocrine Clinical Site
Bellevue, Washington, 98007
- Recruiting
Neurocrine Clinical Site
Decatur, Georgia, 30030
- Recruiting
Neurocrine Clinical Site
Durham, North Carolina, 27707
- Recruiting
Neurocrine Clinical Site
Gainesville, Florida, 32607
- Recruiting
Neurocrine Clinical Site
Garfield Heights, Ohio, 44125
- Recruiting
Neurocrine Clinical Site
Grand Rapids, Michigan, 49503
- Recruiting
Neurocrine Clinical Site
Hialeah, Florida, 33018
- Recruiting
Neurocrine Clinical Site
Hickory, North Carolina, 28601
- Recruiting
Neurocrine Clinical Site
Honolulu, Hawaii, 96817
- Recruiting
Neurocrine Clinical Site
Houston, Texas, 77030
- Recruiting
Neurocrine Clinical Site
Houston, Texas, 77090
- Recruiting
Neurocrine Clinical Site
Jacksonville, Florida, 32256
- Recruiting
Neurocrine Clinical Site
Kansas City, Missouri, 64108
- Recruiting
Neurocrine Clinical Site
Lincoln, Nebraska, 68526
- Recruiting
Neurocrine Clinical Site
Little Rock, Arkansas, 72211
- Recruiting
Neurocrine Clinical Site
Long Beach, California, 90807
- Recruiting
Neurocrine Clinical Site
Los Gatos, California, 95030
- Recruiting
Neurocrine Clinical Site
Miami, Florida, 33173
- Recruiting
Neurocrine Clinical Site
Miami Beach, Florida, 33139
- Recruiting
Neurocrine Clinical Site
Miami Springs, Florida, 33166
- Recruiting
Neurocrine Clinical Site
Michigan City, Indiana, 46360
- Recruiting
Neurocrine Clinical Site
Naperville, Illinois, 60563
- Recruiting
Neurocrine Clinical Site
Nashua, New Hampshire, 03060
- Recruiting
Neurocrine Clinical Site
North Miami, Florida, 33161
- Recruiting
Neurocrine Clinical Site
Oceanside, California, 92056
- Recruiting
Neurocrine Clinical Site
Oklahoma City, Oklahoma, 73112
- Recruiting
Neurocrine Clinical Site
Orlando, Florida, 32803
- Recruiting
Neurocrine Clinical Site
Rochester, Michigan, 48307
- Recruiting
Neurocrine Clinical Site
Salt Lake City, Utah, 84105
- Recruiting
Neurocrine Clinical Site
San Antonio, Texas, 78229
- Recruiting
Neurocrine Clinical Site
St Louis, Missouri, 63128
- Recruiting
Neurocrine Clinical Site
Tampa, Florida, 33613
About this study
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.
- Conditions
- Tardive Dyskinesia
- Medical subject headings
- Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Customized clinician-reported outcomes
Clinician evaluation of patient burden due to tardive dyskinesia symptoms
Measured: 12 months
EuroQOL 5 Dimensions EQ-5D-5L)
General, single index measure for describing and valuing health-related quality of life.
Measured: 12 months
Customized caregiver-reported outcomes:
Caregiver evaluation of perceived burden of symptoms on patients as well as the impact on the caregiver
Measured: 12 months
Sheehan Disability Scale (SDS)
Assessment of functional impairment and disability
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start4 Apr 2017
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tardive DyskinesiaStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Evidera
- Responsible party
- Sponsor
- Investigators
- Chris O'Brien, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062033
- Sponsor's protocol ID
- EVA-19350
- Acronym
- RE-Kinect
- Status last verified
- Nov 2017
- First submitted
- 3 Feb 2017
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents
- ClinicalTrials.gov ID
- NCT03062033
- Acronym / sponsor ID
- RE-Kinect / EVA-19350
- Conditions
- Tardive Dyskinesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Evidera
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients must be 18 years or older with a cumulative lifetime exposure to antipsychotic medication of three months or more.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patient is unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Customized clinician-reported outcomes
Time frame: 12 months
Clinician evaluation of patient burden due to tardive dyskinesia symptoms
EuroQOL 5 Dimensions EQ-5D-5L)
Time frame: 12 months
General, single index measure for describing and valuing health-related quality of life.
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
Sheehan Disability Scale (SDS)
Time frame: 12 months
Assessment of functional impairment and disability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris O'Brien, MD study director
Chief Medical Officer
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tardive Dyskinesia, run by Neurocrine Biosciences at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evidera RE-Kinect Registry Team (1-800-242-2196, rekinect@evidera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Customized clinician-reported outcomes (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.