·  Legal News, Analysis, & Commentary

Mental Health

Cariprazine has been FDA Approved for Treatment of MDD

— December 30, 2022

New antipsychotic medication shows promise for treating major depressive disorder.

Cariprazine (VRAYLAR®) is a prescription drug that has been FDA approved as an additional therapy to antidepressants for the treatment of adult patients with major depressive disorder (MDD). MDD, commonly known as clinical depression, is defined by a chronic low mood and loss of interest in activities, which causes considerable difficulties in everyday functioning.

One-fifth of all U.S. adults will suffer from MDD at some point in their lives. Adding therapy to an antidepressant treatment plan may help alleviate specific depressive symptoms after antidepressant use. According to AbbVie, the maker of Cariprazine, half of the individuals with MDD still had depressive symptoms after taking their first antidepressant. Treatment resistant depression is particular difficult to manage.

Study 3111-301-001 is a third-phase study on FDA approved Cariprazine. In the clinical trial, Cariprazine, a once-daily oral antipsychotic medication, outperformed a placebo. Cariprazine produced a significantly greater change from baseline to week 6, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.

Cariprazine has been FDA Approved for Treatment of MDD
Photo by Daniel Reche from Pexels

Patients administered 2-4.5 mg/day (mean dose 2.6 mg) of the new drug in addition to ADT demonstrated a statistically and clinically significant improvement in the MADRS total score from baseline to week 8 in the registration-enabling RGH-MD-75 study, compared to a placebo plus ADT trial.

An increased risk of adverse events was seen in clinical trials when dosage was titrated at intervals of shorter than 14 days (AEs). Across both 6- and 8-week studies, FDA approved Cariprazine was safe for most participants. In six-week, fixed-dose trials, akathisia, nausea, and sleeplessness were the most frequently seen side effects.

The approval of Cariprazine provides a new treatment option for adult patients with MDD who have experienced an incomplete or partial response to antidepressant medications. The adjunctive use of Cariprazine with antidepressants has been shown to improve patient outcomes, with a decrease in the severity of MDD symptoms overall.

Over 8,000 patients in over 20 clinical trials evaluating the efficacy and safety of Cariprazine in various psychiatric diseases across the globe attest to the drug’s reliability and safety profile. Cariprazine is also approved for the treatment of adult Bipolar I Disorder, depressed, acute manic, as well as schizophrenia.

However, Cariprazine may cause a range of side effects, including constipation, akathisia, increased appetite, weight gain, and changes to lipid levels. Therefore, it is essential to consider potential contraindications, drug interactions, and risks concerning individual patients before prescribing the drug. Specific patient populations, such as those with kidney or hepatic failure, pregnant women, and elderly patients, must be carefully evaluated and monitored for potential risks.

More research needs to be done to better understand Cariprazine’s long-term effects and its efficacy in other psychiatric disorders. Additionally, guidelines should be developed to help clinicians and patients identify potential risks and mitigate them when prescribing and taking the new drug.


The Prevalence of Chronic Kidney Disease and Albuminuria in Patients With Type 1 and Type 2 Diabetes Attending a Single Centre

FDA Approves Cariprazine for Major Depressive Disorder

Cariprazine: A New Atypical Antipsychotic Agent. Clinical Neuropharmacology

Join the conversation!