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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03062033
Acronym
RE-Kinect
Enrollment
70
Registered
2017-02-23
Start date
2017-04-04
Completion date
2018-08-31
Last updated
2017-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tardive Dyskinesia

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.

Interventions

None listed

Sponsors

Evidera
CollaboratorINDUSTRY
Neurocrine Biosciences
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Customized clinician-reported outcomes12 monthsClinician evaluation of patient burden due to tardive dyskinesia symptoms
EuroQOL 5 Dimensions EQ-5D-5L)12 monthsGeneral, single index measure for describing and valuing health-related quality of life.
Customized caregiver-reported outcomes:12 monthsCaregiver evaluation of perceived burden of symptoms on patients as well as the impact on the caregiver
Sheehan Disability Scale (SDS)12 monthsAssessment of functional impairment and disability

Countries

United States

Contacts

Primary ContactEvidera RE-Kinect Registry Team
rekinect@evidera.com1-800-242-2196

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026