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

Sponsor
Neurocrine Biosciences (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03062033
Collaborator
Evidera (Industry)
70
Enrollment
34
Locations
15.9
Anticipated Duration (Months)
2.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    70 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents
    Actual Study Start Date :
    Apr 4, 2017
    Anticipated Primary Completion Date :
    Aug 1, 2018
    Anticipated Study Completion Date :
    Aug 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Customized clinician-reported outcomes [12 months]

      Clinician evaluation of patient burden due to tardive dyskinesia symptoms

    2. EuroQOL 5 Dimensions EQ-5D-5L) [12 months]

      General, single index measure for describing and valuing health-related quality of life.

    3. Customized caregiver-reported outcomes: [12 months]

      Caregiver evaluation of perceived burden of symptoms on patients as well as the impact on the caregiver

    4. Sheehan Disability Scale (SDS) [12 months]

      Assessment of functional impairment and disability

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Neurocrine Clinical Site Little Rock Arkansas United States 72211
    2 Neurocrine Clinical Site Anaheim California United States 92804
    3 Neurocrine Clinical Site Anaheim California United States 92805
    4 Neurocrine Clinical Site Long Beach California United States 90807
    5 Neurocrine Clinical Site Los Gatos California United States 95030
    6 Neurocrine Clinical Site Oceanside California United States 92056
    7 Neurocrine Clinical Site Gainesville Florida United States 32607
    8 Neurocrine Clinical Site Hialeah Florida United States 33018
    9 Neurocrine Clinical Site Jacksonville Florida United States 32256
    10 Neurocrine Clinical Site Miami Beach Florida United States 33139
    11 Neurocrine Clinical Site Miami Springs Florida United States 33166
    12 Neurocrine Clinical Site Miami Florida United States 33173
    13 Neurocrine Clinical Site North Miami Florida United States 33161
    14 Neurocrine Clinical Site Orlando Florida United States 32803
    15 Neurocrine Clinical Site Tampa Florida United States 33613
    16 Neurocrine Clinical Site Decatur Georgia United States 30030
    17 Neurocrine Clinical Site Honolulu Hawaii United States 96817
    18 Neurocrine Clinical Site Naperville Illinois United States 60563
    19 Neurocrine Clinical Site Michigan City Indiana United States 46360
    20 Neurocrine Clinical Site Grand Rapids Michigan United States 49503
    21 Neurocrine Clinical Site Rochester Michigan United States 48307
    22 Neurocrine Clinical Site Kansas City Missouri United States 64108
    23 Neurocrine Clinical Site Saint Louis Missouri United States 63128
    24 Neurocrine Clinical Site Lincoln Nebraska United States 68526
    25 Neurocrine Clinical Site Nashua New Hampshire United States 03060
    26 Neurocrine Clinical Site Durham North Carolina United States 27707
    27 Neurocrine Clinical Site Hickory North Carolina United States 28601
    28 Neurocrine Clinical Site Garfield Heights Ohio United States 44125
    29 Neurocrine Clinical Site Oklahoma City Oklahoma United States 73112
    30 Neurocrine Clinical Site Houston Texas United States 77030
    31 Neurocrine Clinical Site Houston Texas United States 77090
    32 Neurocrine Clinical Site San Antonio Texas United States 78229
    33 Neurocrine Clinical Site Salt Lake City Utah United States 84105
    34 Neurocrine Clinical Site Bellevue Washington United States 98007

    Sponsors and Collaborators

    • Neurocrine Biosciences
    • Evidera

    Investigators

    • Study Director: Chris O'Brien, MD, Chief Medical Officer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Neurocrine Biosciences
    ClinicalTrials.gov Identifier:
    NCT03062033
    Other Study ID Numbers:
    • EVA-19350
    First Posted:
    Feb 23, 2017
    Last Update Posted:
    Nov 22, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Dyskinesias
    Tardive Dyskinesia

    Study Results

    No Results Posted as of Nov 22, 2017