Reviewed by Michael Gill, B. Sc.
8 Vraylar Clinical Trials Near Me
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Most Recent Vraylar Clinical Trials

What Are Vraylar Clinical Trials?

Vraylar is used to treat depressive episodes resulting from bipolar I disorder, also known as bipolar depression, in adults. The medicine is also prescribed to treat manic or mixed episodes that occur with bipolar I disorder. Doctors may also use it to treat schizophrenia.

Bipolar disorder impacts approximately 4 percent of the adult population in the United States. Around a half a percent of the population is affected by schizophrenia. Cariprazine, known as Vraylar when sold in the United States, was approved by the Food and Drug Administration (FDA) in 2015.

Why Is Vraylar Being Studied in Clinical Trials?

Although Vraylar is already approved by the FDA and prescribed by doctors, AbbVie continues to schedule clinical trials to discover new options for treatment with the medication.

One clinical trial was started to test the effectiveness of the drug in pediatric patients aged 10 to 17. With up to 1.8 percent of the pediatric population affected by bipolar disorder, Vraylar could help young patients with limited pharmacotherapeutic options.

How Does Vraylar Treatment Work?

Vraylar works to balance the neurotransmitters of serotonin and dopamine in the brain. By rebalancing dopamine and serotonin, patients should experience improved behavior, thinking, and mood. Specifically, Vraylar acts as a D3 receptor and D2 receptor partial agonist and has high selectivity for the D3 receptor.

Neurotransmitters are the chemicals responsible for helping the brain cells communicate with one another. When the neurotransmitter dopamine doesn’t function properly, humans may experience delusions, hallucinations, and thought disorders.

Patients diagnosed with schizophrenia who take Vraylar should experience an improvement in their daily lives within one to two weeks. Negative symptoms of schizophrenia like social withdrawal, difficulty talking, lack of emotion or joy, and problems dealing with daily life may recede with Vraylar.

Although Vraylar works as an antipsychotic medication, doctors also prescribe it for bipolar disorder as a mood stabilizer. People who experience mania and depression at the same time may find effective treatment with Vraylar.

What Are Some of the Breakthrough Clinical Trials Involving Vraylar?

Clinical trial results released in 2022 showed a statistically significant improvement in Montgomery-Åsberg Depression Rating Scale (MADRS) scores when patients took cariprazine and an antidepressant at the same time.

The clinical trial was a randomized, double-blind, placebo-controlled, flexible-dose, outpatient, multicenter trial conducted in the United States and Europe.

Due to those positive results, manufacturer AbbVie submitted a supplemental new drug application to the FDA to gain approval for doctors to prescribe Vraylar simultaneously with an antidepressant.

Who Are the Key Opinion Leaders on Vraylar Clinical Trial Research?

Vraylar was co-developed by Gedeon Richter Plc and AbbVie. Gedeon Richter Plc. is a Hungarian pharmaceutical company with headquarters in Budapest. The company operates in more than 40 countries with other pharmaceutical companies like AbbVie.

AbbVie is a spin-off company of Abbott Laboratories, formed in 2013. The first well-known drug from AbbVie was Humira. The company also makes drugs like wrinkle-reducer Botox and depression medication Celexa.

AbbVie and Gedeon Richter Plc. developed Vraylar as part of a 15-year collaboration on central nervous system projects.

About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: October 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.