Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes
2 other identifiers
interventional
300
1 country
2
Brief Summary
The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 30, 2023
CompletedFirst Submitted
Initial submission to the registry
August 21, 2023
CompletedFirst Posted
Study publicly available on registry
August 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMarch 12, 2024
March 1, 2024
1.5 years
August 21, 2023
March 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
AIMS Score
Abnormal Involuntary Scale Score
Baseline
Study Arms (2)
Taking antipsychotic medication with Tardive Dyskinesia
OTHERTaking antipsychotic medication without Tardive Dyskinesia
OTHERInterventions
Collecting video data on abnormal movement
Eligibility Criteria
You may qualify if:
- For the non-TD group:
- Prescribed and taking an antipsychotic medication for 90-days or longer.
- Tardive Dyskinesia symptoms if present are not from Parkinsons, Tourette's syndrome, Huntington disease.
- Signed an informed consent.
- Speaks English fluently.
You may not qualify if:
- Suffered a moderate or severe head injury in the last year;
- History of a learning disorder or developmental disability that would inhibit a patient from completing the TD protocol.
- Severe visual impairment that is cannot be corrected by glasses or contacts.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- iRxReminderlead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (2)
Fermata Helath
Brooklyn, New York, 10038, United States
Charak Research Center
Garfield Heights, Ohio, 44125, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rakesh Ranjan, M.D.
Charak Research Center
- STUDY DIRECTOR
Owen Muir, M.D.
Fermata Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2023
First Posted
August 25, 2023
Study Start
May 30, 2023
Primary Completion
November 30, 2024
Study Completion
December 31, 2024
Last Updated
March 12, 2024
Record last verified: 2024-03