Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents
- Conditions
- Tardive Dyskinesia
- Registration Number
- NCT03062033
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
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
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Exclusion Criteria
- Patient is unable to provide informed consent.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method EuroQOL 5 Dimensions EQ-5D-5L) 12 months General, single index measure for describing and valuing health-related quality of life.
Customized clinician-reported outcomes 12 months Clinician evaluation of patient burden due to tardive dyskinesia symptoms
Customized caregiver-reported outcomes: 12 months Caregiver evaluation of perceived burden of symptoms on patients as well as the impact on the caregiver
Sheehan Disability Scale (SDS) 12 months Assessment of functional impairment and disability
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Neurocrine Clinical Site
🇺🇸Bellevue, Washington, United States