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Trial record 34 of 71 for:    Tardive Dyskinesia

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

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ClinicalTrials.gov Identifier: NCT03062033
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
Evidera
Information provided by (Responsible Party):
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.

Condition or disease
Tardive Dyskinesia

Study Type : Observational [Patient Registry]
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Real‐World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Group/Cohort
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



Primary Outcome Measures :
  1. Customized clinician‐reported outcomes [ Time Frame: 12 months ]
    Clinician evaluation of patient burden due to tardive dyskinesia symptoms

  2. EuroQOL 5 Dimensions EQ-5D-5L) [ Time Frame: 12 months ]
    General, single index measure for describing and valuing health-related quality of life.

  3. 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

  4. Sheehan Disability Scale (SDS) [ Time Frame: 12 months ]
    Assessment of functional impairment and disability



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062033


Contacts
Contact: Evidera RE-Kinect Registry Team 1-800-242-2196 rekinect@evidera.com

  Show 34 Study Locations
Sponsors and Collaborators
Neurocrine Biosciences
Evidera
Investigators
Study Director: Chris O'Brien, MD Chief Medical Officer

Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT03062033     History of Changes
Other Study ID Numbers: EVA-19350
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Dyskinesias
Tardive Dyskinesia
Dyskinesia, Drug-Induced
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs