Clinical trial NCT03062033: Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents
Official title: Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tardive Dyskinesia
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
Collaborators: name: Evidera
First posted: 2017-02-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Customized clinician-reported outcomes
timeFrame: 12 months
measure: EuroQOL 5 Dimensions EQ-5D-5L)
timeFrame: 12 months
measure: Customized caregiver-reported outcomes:
timeFrame: 12 months
measure: Sheehan Disability Scale (SDS)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Neurocrine Clinical Site
state: Arkansas
city: Anaheim
country: United States
facility: Neurocrine Clinical Site
state: California
city: Anaheim
country: United States
facility: Neurocrine Clinical Site
state: California
city: Long Beach
country: United States
facility: Neurocrine Clinical Site
state: California
city: Los Gatos
country: United States
facility: Neurocrine Clinical Site
state: California
city: Oceanside
country: United States
facility: Neurocrine Clinical Site
state: California
city: Gainesville
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Hialeah
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Jacksonville
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Miami Beach
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Miami Springs
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Miami
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: North Miami
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Orlando
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Tampa
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Decatur
country: United States
facility: Neurocrine Clinical Site
state: Georgia
city: Honolulu
country: United States
facility: Neurocrine Clinical Site
state: Hawaii
city: Naperville
country: United States
facility: Neurocrine Clinical Site
state: Illinois
city: Michigan City
country: United States
facility: Neurocrine Clinical Site
state: Indiana
city: Grand Rapids
country: United States
facility: Neurocrine Clinical Site
state: Michigan
city: Rochester
country: United States
facility: Neurocrine Clinical Site
state: Michigan
city: Kansas City
country: United States
facility: Neurocrine Clinical Site
state: Missouri
city: Saint Louis
country: United States
facility: Neurocrine Clinical Site
state: Missouri
city: Lincoln
country: United States
facility: Neurocrine Clinical Site
state: Nebraska
city: Nashua
country: United States
facility: Neurocrine Clinical Site
state: New Hampshire
city: Durham
country: United States
facility: Neurocrine Clinical Site
state: North Carolina
city: Hickory
country: United States
facility: Neurocrine Clinical Site
state: North Carolina
city: Garfield Heights
country: United States
facility: Neurocrine Clinical Site
state: Ohio
city: Oklahoma City
country: United States
facility: Neurocrine Clinical Site
state: Oklahoma
city: Houston
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Houston
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: San Antonio
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Salt Lake City
country: United States
facility: Neurocrine Clinical Site
state: Utah
city: Bellevue
country: United States
facility: Neurocrine Clinical Site
state: Washington
Study officials:
affiliation: Chief Medical Officer
name: Chris O'Brien, MD
role: STUDY_DIRECTOR
References: