Tardive DyskinesiaNCT06011408
Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes
A study testing TDtect in people with Tardive Dyskinesia, run by iRxReminder at 2 sites in United States.
Trial summary
The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tardive Dyskinesia
- What is being tested?
- TDtect
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 May 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Fermata Helath
Brooklyn, New York, 10038
Nogga Schwartz, 917-634-4648, nogga.schwartz@fermata.health
Owen Muir, M.D.
- Recruiting
Charak Research Center
Garfield Heights, Ohio, 44125
Kenzie Miller, 216-280-6374, kmiller@atcharakcenter.com
Rakesh Ranjan, M.D.
About this study
The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia.
Read the detailed description
The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia. Participants will all be taking an antipsychotic medication and half will have a diagnosis of Tardive Dyskinesia and half will not. Participant responses to interview questions and elements of the Abnormal Involuntary Movement Scale will be collected on video. The videos will be rated by trained observers. Machine learning methods will be used to develop an algorithm to detect abnormal movements in individuals with a known Tardive Dyskinesia diagnosis. The trained rater results will be compared to the algorithm to determine the accuracy of the algorithm.
- Conditions
- Tardive Dyskinesia
- Being tested
- TDtect
- Medical subject headings
- Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDtectOther
Collecting video data on abnormal movement
| Study group | Role | What they receive |
|---|---|---|
| Taking antipsychotic medication with Tardive Dyskinesia | Other | Not described Receives: Other: TDtect |
| Taking antipsychotic medication without Tardive Dyskinesia | Other | Not described Receives: Other: TDtect |
What is being measured
The primary outcome is the main question the study is designed to answer.
AIMS Score
Abnormal Involuntary Scale Score
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start30 May 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tardive DyskinesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, observational study with two groups taking antipsychotic with or without Tardive Dyskinesia
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iRxReminder
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Rakesh Ranjan, M.D., Study director, Charak Research CenterOwen Muir, M.D., Study director, Fermata Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011408
- Sponsor's protocol ID
- #23-002
- Other IDs
- R43MH114763
- Status last verified
- Mar 2024
- First submitted
- 21 Aug 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes
- ClinicalTrials.gov ID
- NCT06011408
- Acronym / sponsor ID
- #23-002
- Conditions
- Tardive Dyskinesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- iRxReminderIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia.
Detailed description
The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia. Participants will all be taking an antipsychotic medication and half will have a diagnosis of Tardive Dyskinesia and half will not. Participant responses to interview questions and elements of the Abnormal Involuntary Movement Scale will be collected on video. The videos will be rated by trained observers. Machine learning methods will be used to develop an algorithm to detect abnormal movements in individuals with a known Tardive Dyskinesia diagnosis. The trained rater results will be compared to the algorithm to determine the accuracy of the algorithm.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, observational study with two groups taking antipsychotic with or without Tardive Dyskinesia
| Arm | Type | Receives |
|---|---|---|
| Taking antipsychotic medication with Tardive Dyskinesia | Other | Other: TDtect |
| Taking antipsychotic medication without Tardive Dyskinesia | Other | Other: TDtect |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDtectCollecting video data on abnormal movement | Other | Taking antipsychotic medication with Tardive Dyskinesia, Taking antipsychotic medication without Tardive Dyskinesia |
Primary outcome
AIMS Score
Time frame: Baseline
Abnormal Involuntary Scale Score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Tardive Dyskinesia
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A Computer-Assisted Tool for Objective Assessment of Extrapyramidal Symptoms
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Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
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Single-Center, Double-Blind, Randomized, Placebo-Controlled Study on Efficacy and Safety of rTMS (With Precise Localization) in Relieving Motor Symptoms of TD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rakesh Ranjan, M.D. study director
Charak Research Center
Owen Muir, M.D. study director
Fermata Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TDtect in people with Tardive Dyskinesia, run by iRxReminder at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anthony Sterns, Ph.D. (3306066675, asterns@irxreminder.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AIMS Score (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.