Tardive dyskinesia (TD) is a neurological disorder that manifests as involuntary and repetitive movements, often as a side effect of long-term use of antipsychotic medications. While treatments exist to manage symptoms, ongoing research is critical for understanding the condition and discovering better therapeutic approaches. Clinical trials play a vital role in this endeavor, offering individuals access to cutting-edge treatments while contributing to the advancement of medical knowledge.
This article explores the clinical trials available for tardive dyskinesia, highlighting their purpose, benefits, and eligibility requirements. It also provides a detailed list of trials currently underway to aid patients and caregivers in finding appropriate studies.
Understanding Clinical Trials for Tardive Dyskinesia
Clinical trials are research studies designed to evaluate the safety, efficacy, and side effects of new treatments, therapies, or interventions. For tardive dyskinesia, these trials may focus on:
- Testing new medications to alleviate symptoms.
- Investigating alternative therapies, such as neuromodulation techniques.
- Studying the underlying mechanisms of TD to identify biomarkers.
- Evaluating non-pharmacological approaches, including behavioral therapies.
Participation in a clinical trial can provide access to innovative treatments and personalized care while contributing to a deeper understanding of this condition.
Why Participate in a Clinical Trial for Tardive Dyskinesia?
There are several compelling reasons to consider participating in a clinical trial for TD:
- Access to New Treatments: Clinical trials provide participants with early access to experimental treatments that are not yet widely available.
- Personalized Care: Participants often receive specialized medical attention, including regular monitoring and tailored treatment plans.
- Contribution to Science: Joining a trial helps advance medical research, paving the way for future breakthroughs in the treatment of TD.
- Compensation and Support: Many trials offer financial compensation for travel and time, along with additional support during the study.
While there are clear benefits, participants should also consider potential risks, such as side effects or receiving a placebo instead of the active treatment.
Types of Clinical Trials for Tardive Dyskinesia
Clinical trials for TD encompass a variety of approaches:
- Medication Trials: These studies test new drugs or combinations of drugs to determine their effectiveness in managing TD symptoms. For instance, medications like VMAT2 inhibitors are often the focus of these trials.
- Behavioral Therapy Trials: These trials evaluate the impact of non-drug interventions, such as mindfulness, relaxation techniques, or physical therapy, on symptom management.
- Neuromodulation Trials: Emerging research explores the use of techniques like transcranial magnetic stimulation (TMS) or deep brain stimulation (DBS) for treating TD.
- Long-Term Safety Studies: These trials assess the long-term effects of existing or newly approved treatments to ensure their safety and efficacy over extended periods.
- Genetic and Biomarker Studies: Research in this area seeks to identify genetic markers or other biological indicators that could predict the onset or progression of TD, leading to more personalized treatment approaches.
Who Can Participate in a Tardive Dyskinesia Clinical Trial?
Each clinical trial has specific eligibility criteria to ensure the safety of participants and the integrity of the research. Common factors include:
- Diagnosis: Participants must typically have a confirmed diagnosis of tardive dyskinesia.
- Age: Many trials have age requirements, often focusing on adults over 18.
- Medication History: Trials may require participants to have a history of taking antipsychotic medications or other drugs associated with TD.
- Health Status: Participants must meet certain health criteria, which may include physical and mental health assessments.
- Previous Treatment: Some studies focus on patients who have tried and failed standard treatments, while others may recruit treatment-naïve participants.
Before enrolling, potential participants undergo a screening process to determine their eligibility.
How to Find Tardive Dyskinesia Clinical Trials
Finding the right clinical trial for TD involves thorough research and consultation with healthcare providers. Here are some resources to help:
- ClinicalTrials.gov: This comprehensive database lists clinical trials worldwide, including those focused on TD. You can filter by location, study phase, and eligibility criteria.
- Research Hospitals and Universities: Many leading institutions conduct TD clinical trials. Contacting their research departments can provide information on current studies.
- Non-Profit Organizations: Organizations like the National Organization for Rare Disorders (NORD) and the Tourette Association of America may have information about TD trials.
- Pharmaceutical Companies: Companies developing treatments for TD often recruit participants for trials through their websites.
- Local Healthcare Providers: Your doctor or psychiatrist may know about trials in your area and can help you determine if participation is right for you.
List of Current Clinical Trials for Tardive Dyskinesia
Clinical Trials.Gov allows you to search for clinical trials for Tardive Dyskinesia
Psychological Adjustment to Tardive Dyskinesia
The purpose of this research project is to determine the feasibility of a larger study aimed at demonstrating that treatment of tardive dyskinesia with Valbenazine is associated with reduction of demoralizationDetailed DescriptionThis will be an Investigator-initiated, prospective, single center, interventional pilot study. This study will examine the feasibility of a larger study aimed at determining if there is an association between the improvement in tardive dyskinesia and the reduction in demoralization and subjective incompetence in patients with tardive dyskinesia after treatment with Valbenazine. Participants will be treated with Valbenazine for a total of 7 weeks.
Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes
The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia.Detailed DescriptionThe 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.
This is a single-center, randomized, double-blind, placebo-controlled, multiple-ascending doses trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for later clinical trials.Official TitleA Randomized, Double-blind, Placebo-controlled, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic of Multiple-ascending Doses of LPM3770164 Sustained-release Tablets in Healthy Subjects
To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in smoking status and neurological symptoms using standardized rating scales. The aim is to examine clinically significant effects on antipsychotic-induced neurological side effects that may warrant further investigation.
Detailed Description
- Objectives(s): To study whether smoking cessation with varenicline treatment will be associated with a significant reduction in symptoms of antipsychotic-induced tardive dyskinesia without worsening acute extrapyramidal symptoms.
- Research Design: To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week exploratory, open-label, proof-of-concept, pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in smoking status and neurological symptoms using standardized rating scales. The aim is to examine clinically significant effects on antipsychotic-induced neurological side effects that may warrant further investigation.
- Methodology: Patients will be evaluated at a Screening Visit 1 (Week 0) and at a Baseline Visit 2 (Week 2) two weeks apart. After the Baseline Visit, subjects will be asked to cease smoking completely by the target date four weeks after the baseline visit (Week 6) and will attend a clinic Cessation Visit 4 (Week 6) for medication check and resupply. Treatment with varenicline will start at Baseline Visit 2 (Week 2) with 0.5mg hs x 3 days, 0.5mg bid x 4 days, then start 1mg bid at Visit 3 (Week 3) for the remaining 9 weeks of the study.
At the Screening and Baseline Visits, and at study visits thereafter (Visit 3-7), subjects will be evaluated for efficacy and safety, and changes in smoking or other tobacco use since the last visit. The following measures will be taken; Fagerstrom Test for Cigarette Dependence (FTCD) at screening only; Cigarette smoking will be assessed by a structured questionnaire of time-line follow-back (TLFB) usage; Expired carbon using a hand-held carbon monoxide monitor; Simpson-Angus Scale (SAS), Barnes Akathisia Scale (BAS), and the Abnormal Involuntary Movement Scale (AIMS); Global Clinical Impression Scale (CGI-S at baseline, CGI-I at final visit) for TD; C-SSRS; Brief Psychiatric Rating Scale (BPRS), Mini-Mental Status Examination (MMSE) and Hospital Anxiety and Depression Scale (HADS) at baseline and the final visit only; Brief smoking cessation counseling; Laboratory measures; Urine toxicology sample at the screening and final visits only, serum pregnancy test (women) at screening visit only; Changes in psychotropic medications; Varenicline compliance by pill counts; Adverse events.
Conclusion
Tardive dyskinesia clinical trials offer hope for improved treatments and a better understanding of this challenging condition. By participating, individuals gain access to innovative therapies while contributing to the advancement of medical research. If you or a loved one is considering joining a trial, consult your healthcare provider to explore the options and take a step toward improving care for TD.
