A new clinical trial for movement disorder

Whether for depression, bipolar disorder or schizophrenia, numerous people find relief in managing their mental health condition by taking psychiatric medication. However, these medications can come with various side effects, such as tardive dyskinesia (TD).

This is a disorder characterized by uncontrollable, repetitive bodily or facial movements. Scientists believe that some antipsychotic medications affect dopamine levels in a way that causes TD.

Approximately 600,000 to 800,000 people in the U.S. have TD, and its mild to severe symptoms can make everyday life uncomfortable and difficult. To help manage this condition, researchers developed a medication called valbenazine, which is approved by the U.S. Food and Drug Administration (FDA).

Evaluating the impact of restarting valbenazine

According to Dr. Paulette Cazares, principal investigator at the Sharp Neurocognitive Research Center, valbenazine works by affecting how dopamine is released in the brain, which helps reduce involuntary movements sometimes caused by antipsychotic medications.

She adds that many doctors want to help ease side effects from antipsychotic medications, especially because they can be critical in treating certain underlying mental health conditions.

“People are all different, so it can take a few tries to find a psychiatric medication that works well for someone,” she says. “That’s why if a medicine is a good fit, we want to keep that in place for a patient who needs it and then help manage any side effects.”

As part of its efforts to help find effective treatment for various mental health conditions, Sharp Neurocognitive Research Center is currently running a clinical trial to evaluate the impact of restarting valbenazine for people with TD who either previously came off of it for any reason or are still having symptoms of TD on a different medication.

Study requirements and details

KINECT-Again is a Phase 4 study, meaning it has already completed previous stages to examine the medicine’s efficacy. Eligibility requirements include:

• Being 18 years old or older

• Diagnosed with one of the following at least three months prior to screening: schizophrenia, bipolar disorder or major depressive disorder

• Diagnosed with at least mild TD for at least 3 months prior to screening

• Are either currently taking a VMAT2 inhibitor or have previously been treated with a VMAT2 inhibitor, such as deutetrabenazine

Participants will orally take the valbenazine pill once a day for 24 weeks. They will also have nine study visits, one of which will be virtual. The visits are to report on their mental health and TD symptoms.

“As a center that has participated in over 350 clinical trials, our team understands research and the value it can bring to individuals and to science,” says Dr. Cazares. “Our team is caring, and we have a deep appreciation for those who participate in research.”

Dr. Cazares adds that everyone deserves care that can lessen discomfort or pain. “We're hoping this and other studies like it can help those struggling with these symptoms,” she says. “We welcome anyone interested to contact us. We'd love to answer questions or welcome you to the study.”

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