Is Vraylar (cariprazine) effective for treating schizophrenia?

From the Guidelines

Vraylar (cariprazine) is an effective treatment option for schizophrenia, as it has been shown to reduce both positive and negative symptoms of the disorder. According to the American Psychiatric Association practice guideline for the treatment of patients with schizophrenia 1, antipsychotic medications are a crucial component of treatment, and Vraylar, as an atypical antipsychotic, modulates dopamine and serotonin receptors in the brain, particularly as a partial agonist at D2 and D3 receptors.

Key Points About Vraylar for Schizophrenia

• The typical dosing for schizophrenia starts at 1.5 mg once daily, which can be increased to 3-6 mg daily based on response and tolerability.
• Clinical trials have demonstrated the efficacy of Vraylar in reducing symptoms of schizophrenia, including both positive symptoms (like hallucinations and delusions) and negative symptoms (such as lack of motivation and social withdrawal).
• Common side effects include restlessness (akathisia), digestive issues, and weight changes, though Vraylar tends to have a more favorable metabolic profile compared to some other antipsychotics.
• Regular monitoring for movement disorders, metabolic changes, and cardiovascular effects is necessary during treatment, as recommended by the APA guideline 1.

Considerations for Treatment

• The APA recommends that patients with schizophrenia have a documented, comprehensive, and person-centered treatment plan that includes evidence-based nonpharmacological and pharmacological treatments 1.
• Vraylar, as part of a comprehensive treatment plan, can help improve outcomes for patients with schizophrenia by reducing symptoms and improving quality of life.
• It's essential to consider the individual patient's needs, preferences, and history when selecting an antipsychotic medication, including Vraylar, and to monitor its effectiveness and side effects closely 1.

From the FDA Drug Label

The efficacy of VRAYLAR for the treatment of schizophrenia was established in three, 6-week, randomized, double-blind, placebo-controlled trials in patients (mean age of 37 years, aged 18 to 60 years; 31% were female; and 45% were Caucasian) who met Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision (DSM-IV-TR) criteria for schizophrenia In each study, the primary endpoint was change from baseline in PANSS total score at the end of week 6. The results of the trials are shown in Table 16. The efficacy of VRAYLAR was demonstrated at doses ranging from 1.5 to 9 mg/day compared to placebo.

Vraylar (cariprazine) is effective for treating schizophrenia.

• The drug was superior to placebo in three 6-week, randomized, double-blind, placebo-controlled trials.
• The primary endpoint was change from baseline in PANSS total score at the end of week 6.
• The efficacy of Vraylar was demonstrated at doses ranging from 1.5 to 9 mg/day compared to placebo.
• The maximum recommended dose is 6 mg/day 2.

From the Research

Efficacy of Vraylar for Schizophrenia

• Vraylar (cariprazine) has been shown to be effective in treating schizophrenia, with significant improvements in Positive and Negative Syndrome Scale (PANSS) total scores compared to placebo 3.
• Cariprazine was also found to be effective in improving PANSS Factor Score for Negative Symptoms in patients with predominantly negative symptoms of schizophrenia, a group that is typically difficult to treat 3.
• A systematic review of case studies found that cariprazine was safe and effective in a wide range of psychiatric conditions, including schizophrenia, with different symptom profiles 4.
• Clinical trials have demonstrated the efficacy of cariprazine in treating acute schizophrenia, with pooled responder rates of 31% for cariprazine compared to 21% for placebo 5.

Effectiveness in Specific Patient Populations

• Cariprazine has been shown to be effective in young patients with schizophrenia and predominantly negative symptoms, with significant improvements in negative symptoms, global functioning, and clinical global impression 6.
• A case series found that switching from clozapine to cariprazine was effective in improving positive and negative symptoms in patients with persistent symptoms of schizophrenia, with significant improvement observed up to 14 months after starting cariprazine 7.

Tolerability and Safety

• Cariprazine has been found to be generally well-tolerated, with most adverse events being of mild to moderate severity, and metabolic changes observed were considered generally not clinically significant 3.
• Common adverse events associated with cariprazine include extrapyramidal symptoms and akathisia, with a number needed to harm (NNH) of 15 for cariprazine 1.5-3 mg/d and NNH of 10 for 4.5-6 mg/d 5.