Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tardive Dyskinesia
- Sponsor
- Neurocrine Biosciences
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- EuroQOL 5 Dimensions EQ-5D-5L)
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
EuroQOL 5 Dimensions EQ-5D-5L)
Time Frame: 12 months
General, single index measure for describing and valuing health-related quality of life.
Customized clinician-reported outcomes
Time Frame: 12 months
Clinician evaluation of patient burden due to tardive dyskinesia symptoms
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