Vraylar (cariprazine) is an atypical antipsychotic that’s gained attention for its growing list of uses in mental health treatment. Initially approved by the FDA in 2015, its approved uses have since then expanded, and so has interest in its off-label potential for other psychiatric conditions.
Vraylar targets two brain chemicals called dopamine and serotonin, which influence mood, thinking, and behavior. These chemicals are often out of balance in conditions like psychosis, depression, mania, and cognitive disorders. Vraylar helps stabilize this activity by increasing it when levels are too low and reducing it when levels are too high.
In this article, we’ll take a closer look at Vraylar’s uses, review the clinical evidence behind its effectiveness, and explore how it is being used to manage complex mental health challenges.
FDA-Approved Vraylar Uses
Vraylar is used for the following conditions:
1. Schizophrenia
Schizophrenia is a complex mental health disorder that affects how a person thinks, feels, and behaves. It often distorts a person’s sense of reality, making it difficult to distinguish what’s real from what isn’t. This disconnection can be distressing for both the individual and those around them.
The World Health Organization estimates that approximately 24 million people live with schizophrenia worldwide. It remains one of the leading causes of disability across the globe.
In 2015, the FDA approved Vraylar for the treatment of schizophrenia in adults. This approval was based on several clinical trials demonstrating that the medication significantly reduced symptoms and overall illness severity.
How effective is Vraylar for Schizophrenia?
One study looked at how Vraylar compares to risperidone. Both drugs were used to treat negative symptoms like:
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- Lack of motivation
- Reduced emotional expression
- Social withdrawal
These symptoms can last a long time and are hard to treat.
The study found that both medications helped. But Vraylar worked a little better. People on Vraylar improved by 8.9 points on a symptom scale. Those on risperidone improved by 7.4 points.
Another study revealed that Vraylar reduced the risk of relapse by more than half, which is important in long-term schizophrenia management. Only 25% of people on Vraylar experienced a relapse, compared to 48% of those taking a placebo.
In addition to treating core symptoms, Vraylar also helped address complications that developed from prior antipsychotic treatments. For instance, one patient gained 30 kg (~66 lbs) and had high cholesterol and triglyceride levels after taking olanzapine (Zyprexa) for a year. After switching to Vraylar, things improved.
2. Bipolar I Disorder
Bipolar I disorder is a serious mental health condition that brings intense shifts in mood, energy, and activity that can disrupt everyday life. People living with it often find it harder to manage work, school, or relationships. It’s also linked with higher rates of anxiety, substance use, and even suicide risk.
Vraylar was approved in 2015 to treat the manic and mixed episodes of bipolar I in adults.
In 2019, the FDA extended Vraylar’s approved uses to include depressive episodes associated with bipolar I disorder. This decision followed a major study where patients taking Vraylar had significantly lower scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to those on placebo.
How effective is Vraylar for Bipolar I Disorder?
Beyond controlled trials, Vraylar has also been studied in real-world settings and clinical case reports involving patients with bipolar I disorder.
In one analysis, researchers observed that Vraylar led to more noticeable improvements in cognitive symptoms among patients experiencing manic or mixed episodes. On average, patients taking Vraylar saw a 4.0-point improvement in cognitive symptoms, compared to a 1.9-point improvement in those taking a placebo.
Some of the biggest changes were seen in:
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- Disorganized thinking
- Trouble with abstract thought
- Repetitive or rigid thinking patterns
- Difficulty paying attention
Another study looked at people with bipolar I depression. After 8 weeks of treatment, Vraylar didn’t just lift mood, it also helped people manage daily responsibilities more easily. That meant better follow-through with tasks, improved relationships, and more consistency at work or home.
3. Adjunctive Treatment for Major Depressive Disorder (MDD)
MDD is another serious and common mental health condition that affects how you feel, think, and function. People with MDD experience persistent feelings of sadness, hopelessness, or emptiness.
A large study found that between up to 66% of people with depression don’t fully recover with just an antidepressant, and only about 1 in 3 achieve full remission. This shows that relying on antidepressants alone doesn’t work for everyone, and many people need a combination of treatments to see improvement.
In December 2022, the FDA approved Vraylar as an add-on treatment to antidepressants for adults with MDD. This approval came after studies showed that pairing Vraylar with an antidepressant worked better than using antidepressants alone.
How effective is Vraylar for MDD?
In a phase 3 trial, people who added Vraylar 1.5 mg per day to their antidepressant regimen saw a stronger improvement in depression scores. Their symptoms improved by an average of 14.1 points, compared to 11.5 points in those who received a placebo. Some began noticing benefits as early as the second week of treatment.
A separate real-world study looked at data from 2018 to 2021, when Vraylar was still being prescribed off-label for MDD. Even without FDA approval at the time, people using Vraylar had:
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- Fewer hospital stays
- Fewer ER visits for depression compared to people on aripiprazole (Abilify) or quetiapine (Seroquel)
- Fewer overall doctor and psychiatric visits than most other groups
These patterns suggest that people on Vraylar may have experienced better control of their symptoms, requiring less frequent use of healthcare services.
Vraylar Off-Label Uses
While Vraylar’s FDA-approved uses are well-established, clinicians have explored its off-label applications in various psychiatric conditions, often based on how the drug works and what early research suggests.
These include:
1. Bipolar II Disorder
Bipolar II disorder involves recurring episodes of major depression and hypomania. Hypomania is a milder form of elevated mood that is less intense than the full-blown mania seen in bipolar I.
People with bipolar II often go through deep, long-lasting depressive episodes. These can be more severe than those in bipolar I. However, they do not experience the extreme manic episodes that define bipolar I.
One early study tested whether Vraylar could help with depression in bipolar II. The results showed that it didn’t work better than a placebo in reducing symptoms. Still, the medication was generally well-tolerated, with no major safety concerns. More research is needed to understand how effective Vraylar might be for this condition.
Despite limited data, some doctors are already prescribing Vraylar off-label.
In one Reddit discussion, a user shared that they had stopped Lamictal and Abilify during pregnancy. Later, feeling that “high functioning” wasn’t enough, they started Vraylar under a new psychiatrist’s care. After six days, they reported feeling exhausted, having hot flashes, nausea, and trouble focusing. They asked if others had similar experiences.
Several users said they had initial side effects as well, but these went away over time. Some described Vraylar as life-changing. One person mentioned they hadn’t been hospitalized in five years since starting the medication. Commenters encouraged the user to stick with it, suggesting the early side effects might subside and the benefits could be worth the wait.
2. Schizoaffective Disorder
Schizoaffective disorder presents with symptoms of both schizophrenia and mood disorders. Vraylar’s combined antipsychotic and mood-stabilizing properties make it a candidate for off-label use in this condition.
In a case report, a 31-year-old man was referred to a psychiatric clinic due to unusual behavior and alcohol abuse. He had a 10-year history of psychiatric issues, including two hospitalizations for suicide attempts.
Because of the combination of his symptoms, doctors diagnosed him with schizoaffective disorder, depressive type, following the DSM-5 guidelines.
Treatment was initiated with Vraylar 1.5 mg daily for the first week, then increased to 3 mg daily for two more weeks, and subsequently to 4.5 mg. After 4 weeks:
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- Delusions and disorganized thinking stopped
- Depression symptoms also resolved
- He achieved remission (minimal or no symptoms)
Over the next few months, his condition continued to improve. After 16 weeks, he requested to stop daily medication. The doctors modified his treatment plan to 6 mg of Vraylar twice a week (on Mondays and Tuesdays), supervised by a nurse. This reduced schedule successfully kept his symptoms under control, and he remained stable and in remission.
3. Treatment-Resistant Depression
Vraylar is not specifically approved for treatment-resistant depression (TRD), which is typically defined as depression that does not respond to at least two different antidepressant treatments. While the term “inadequate response” used in the MDD approval may overlap with TRD in clinical practice, the FDA’s approval does not explicitly cover TRD.
In a peer-reviewed case report, a middle-aged woman with a graduate degree and a full-time job developed MDD. Her symptoms included:
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- Depressed mood
- Loss of interest
- Low energy
- Sleep issues
- Trouble concentrating
- Suicidal thoughts
Initial treatment with venlafaxine and trazodone did not help. After a suicide attempt, her medication was changed to fluoxetine and quetiapine. Although some symptoms improved, others persisted.
Because of limited progress, bupropion and lithium were added. Still, her condition did not improve enough. She was then given electroconvulsive therapy (ECT), but it had limited results and had to be stopped due to severe bradycardia (slow heart rate).
When Vraylar was added, her symptoms only partially improved. Clozapine was then introduced and helped with both her psychotic and depressive symptoms, and Vraylar was gradually stopped to reduce medication load.
However, she developed urgency urinary incontinence (UI) from clozapine. This refers to a sudden need to urinate, followed by involuntary leaking, which occurred frequently, was distressing, and was even observed by medical staff.
Reintroducing Vraylar led to a significant reduction in UI episodes. After a few months, clozapine was stopped, and UI completely resolved. By the 17th month, she returned to work, stabilized on fluoxetine, lithium, and Vraylar.
4. Borderline Personality Disorder (BPD)
BPD involves intense mood shifts, impulsive behavior, confusing thoughts, and unstable relationships. As of now, the FDA hasn’t approved any medication specifically for treating BPD.
Even though scientists don’t fully understand how BPD works in the brain, research suggests that problems in the brain’s serotonin and dopamine systems may be involved. Vraylar targets both of these pathways, which may explain its potential use in managing BPD symptoms.
In a case report, a 42-year-old man scored 18 on a rating scale for BPD, meaning he had a moderate level of symptoms. He had already tried behavioral therapy for a year, which helped a little. He also tried olanzapine, but it caused him to gain too much weight, so he stopped taking it.
At the time he arrived for care, he wasn’t taking any medications and agreed to try Vraylar off-label. He started with 3 mg daily and was increased gradually to 6 mg per day. After 2 months on this dose:
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- He had less anxiety
- Better mood stability
- No more angry outbursts
After 7 months, his BPD rating score dropped from 18 to 8, which is a significant improvement. He had no signs of anger or impulsive behaviors and had no side effects from the medication.
5. Autism Spectrum Disorder (ASD)
In some cases, Vraylar has been used off-label to manage irritability and aggression in individuals with ASD. However, this application is based on limited evidence, and other antipsychotics like risperidone are more commonly used for this purpose.
However, in a case series involving six ASD patients treated with Vraylar, experts observed noticeable improvement in tough behaviors like:
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- Anger
- Aggression
- Self-harm
- Mania-like behavior
- Paranoia and hyper-religious thoughts
Families and caregivers also noticed better communication and social skills, especially in one standout case. A man with level 3 ASD (the most severe type) gained independence to live in his own apartment with little help, complete a college degree, and get a job.
Moreover, Vraylar showed no significant changes in weight or metabolism. This is an important consideration, especially for individuals with ASD who are already at higher risk for developing metabolic conditions.
An early study also showed that Vraylar may be safe and tolerable for children with ASD, even at low doses, and there were some promising signs that it might help with behavior.
Summary
Vraylar is an FDA-approved medication for schizophrenia, bipolar I disorder (including manic and depressive episodes), and as an add-on for major depressive disorder. Studies show it helps reduce symptoms, lowers the risk of relapse, and improves daily functioning.
It’s also used off-label for conditions like bipolar II disorder, schizoaffective disorder, borderline personality disorder, autism spectrum disorder, and treatment-resistant depression. While not officially approved for these uses, early reports and case studies suggest it may help when other treatments don’t work.
However, it’s not for everyone. Side effects like restlessness or nausea can happen, and more research is still needed for its off-label uses.
Nonetheless, Vraylar is a strong option for people with hard-to-treat mental health conditions, especially when standard treatments haven’t been enough.
Frequently Asked Questions
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