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Starting in her early twenties, Lindsay noticed some extreme changes in her mood and behavior.

"I was making all kinds of impulsive decisions," Lindsay remembered. "One day I would go on a huge shopping spree, not worrying about the money I didn't have. The next day I felt so depressed I would end up in bed all day not doing anything. There was no happy medium."

These highs and lows were unpredictable, making it hard for her to know what each day would look like, even after she became a mother. "Living with these symptoms was driving me crazy and I didn't know what to do," Lindsay said. "As a mother, it was becoming tougher to take care of my kids. I always worried that today would be the day they couldn't count on me to be there for them."

These concerns led Lindsay to seek help. Although she didn't receive a diagnosis from her doctor, she was treated for the symptoms she was experiencing.

"The antidepressants I was taking helped a little, but nothing was working the way I needed it to," Lindsay said. "A few years later, I found a new doctor that talked with me and diagnosed me right away with bipolar I depression."

Difficulties with diagnoses

Lindsay's story is not unusual, as uncovering the correct diagnosis for bipolar disorder can take time.

"Diagnosing bipolar I and II depression is sadly often a lengthy process - five years for bipolar I and ten for bipolar II, on average," said Dr. Greg Mattingly. "In general, both bipolar I and II can be misdiagnosed as major depressive disorder up to 3/4 of the time."¹

Dr. Mattingly advises other providers to seek additional clues, beyond depressive episodes, to diagnose bipolar disorder. "Additional symptoms may include the 4 'A's: anxiety, agitation, anger and attention problems," explained Dr. Mattingly. "Also, inadequate response to multiple antidepressants can suggest bipolar depression, as was the case for Lindsay."

What is bipolar disorder?

Bipolar disorder is a common mental health condition that causes extreme changes in mood and behavior. These changes, or mood episodes, can cause you to experience lows (depression) and highs (mania).^3,4 Mood episodes can affect your sleep, energy, activity, judgment, behavior, and the ability to think clearly.²

The Lows

The lows of bipolar disorder, also known as bipolar depression or depressive episodes, can make people feel sad or hopeless. They may lose interest or pleasure in most activities, even those they once enjoyed. These depressive episodes may be present through their lives, and some episodes may even last several months.⁵

People with bipolar depression typically spend more time in the lows than in the highs of the illness. The lows can be the more debilitating state for some people and may have a greater impact than manic episodes on everyday function. About 90% of people report severe impairment due to depressive episodes.^4,6

The Highs

The highs of bipolar disorder, known as manic or hypomanic episodes, can cause people to feel euphoric, impulsive, unusually irritable, or have an abnormal amount of increased energy. Symptoms during hypomanic episodes are milder than manic episodes.⁵

Manic symptoms are usually reported less frequently and can often be easily overlooked or seen as something positive rather than a sign of bipolar disorder. People with bipolar disorder are three times more likely to experience bipolar depression than mania.⁴

Effective treatment for bipolar disorder

Discovering the correct diagnosis is the first step toward finding effective treatment. If you're experiencing symptoms of bipolar depression, it's important to talk to a healthcare provider who specializes in mental health, and to have open conversations about all your symptoms to identify bipolar depression and the best treatment path.⁴

"When I was finally diagnosed with bipolar I depression, I worried about the stigma associated with it," said Lindsay. "But my doctor told me that together, we could manage this! After a few years of trying different treatments, I had a doctor tell me about a medication called CAPLYTA."

CAPLYTA^® (lumateperone) is a once-daily pill that is proven to deliver significant relief across bipolar depression in adults and can be taken alone or with the medicines lithium or valproate.⁷

Studies have shown CAPLYTA is proven to provide significant relief from depressive symptoms of bipolar disorder and can reduce the overall severity of bipolar depression. Unlike some medications that can only treat bipolar I depression, CAPLYTA treats both bipolar I and bipolar II depression and can be taken alone or with lithium or valproate.

CAPLYTA has Boxed Warnings for increased risk of death in elderly people with dementia-related psychosis and increased risk of suicidal thoughts and behaviors in children and young adults. CAPLYTA is not approved for people under 18. See additional important safety information below.

"When I talked to my doctor about CAPLYTA, I liked hearing that CAPLYTA could make a difference when it comes to improving my bipolar depression symptoms," said Lindsay. Getting her symptoms under control was important to Lindsay and her doctor.

At first, Lindsay was worried about weight gain with CAPLYTA. But her healthcare provider reassured her that most people who took CAPLYTA did not gain weight or have changes in their blood sugar or cholesterol in short- or long-term clinical trials. At 6 months, the average weight change for people on CAPLYTA was -0.02 lbs.

CAPLYTA may cause problems with your metabolism including high blood sugar, diabetes, increased fat (cholesterol and triglyceride) levels in your blood and weight gain. Most people in clinical studies did not have a change in their blood sugar, cholesterol, or weight. Your healthcare provider should check your blood sugar, fat levels, and weight before you start, or soon after you start CAPLYTA, and then periodically during treatment.

"I like that CAPLYTA is approved to treat both bipolar I and bipolar II depression," said Dr. Mattingly. "The proven efficacy and well-established safety and tolerability profile, along with the convenient once-daily dosing, make CAPLYTA an excellent choice for a patient like Lindsay. But remember, every patient experience will be unique, so it's important to monitor for potential side effects such as sudden mood changes, behaviors, or suicidal thoughts. It's really important to talk to your healthcare provider about any concerns or questions you have. I encourage all of my patients to be proactive and to come to me with any questions they may have or side effects they may experience."

"Since taking CAPLYTA I've noticed a real difference," Lindsay noted. "I have fewer extreme highs and lows. I have some energy back and I get out of bed in the morning ready to face the day."

The most common side effects experienced by people with bipolar depression taking CAPLYTA were sleepiness, dizziness, nausea, and dry mouth. CAPLYTA can cause sleepiness and difficulty thinking. Until a patient is aware of how CAPLYTA may affect them, they should not drive, operate heavy machinery, or do other dangerous activities. These are not all the possible side effects, please see the Important Safety Information, including Boxed Warnings, below.

If you or a loved one is struggling with bipolar depression, CAPLYTA may be able to help. Talk to your healthcare provider and ask if CAPLYTA is right for you. To learn more, visit CAPLYTA.com.

CAPLYTA^® (lumateperone) is a prescription medication used in adults for the treatment of depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression). CAPLYTA can be taken alone or with the medicines lithium or valproate for bipolar depression. It is not known if CAPLYTA is safe and effective in children.

Important Safety Information

Medicines like CAPLYTA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). CAPLYTA is not approved for treating people with dementia-related psychosis.

CAPLYTA and antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Patients and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when CAPLYTA or an antidepressant medicine is started or when the dose is changed. Report any change in these symptoms to your healthcare provider immediately.

Do not take CAPLYTA if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (e.g., rash, itching, hives, swelling of the tongue, lip, face, or throat).

CAPLYTA may cause serious side effects, including:

• Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.
• Neuroleptic malignant syndrome (NMS): high fever, confusion, changes in your breathing, heart rate, and blood pressure, stiff muscles, and increased sweating; these may be symptoms of a rare but potentially fatal condition. Contact your healthcare provider or go to the emergency room if you experience signs and symptoms of NMS.
• Uncontrolled body movements (tardive dyskinesia, TD) in your face, tongue, or other body parts. TD may not go away, even if you stop taking CAPLYTA. It may also occur after you stop taking CAPLYTA.
• Problems with your metabolism including high blood sugar, diabetes, increased fat (cholesterol and triglyceride) levels in your blood and weight gain. Your healthcare provider should check your blood sugar, fat levels and weight before you start and during your treatment with CAPLYTA. Extremely high blood sugar levels can lead to coma or death. Call your healthcare provider if you have any of the following symptoms of high blood sugar: feeling very thirsty, hungry, sick to your stomach, needing to urinate more than usual, weak/tired, or confused, or your breath smells fruity.
• Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with CAPLYTA.
• Decreased blood pressure (orthostatic hypotension). You may feel lightheaded, dizzy, or faint when you rise too quickly from a sitting or lying position.
• Falls. CAPLYTA may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause broken bones or other injuries.
• Seizures (convulsions).
• Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Until you know how CAPLYTA affects you, do not drive, operate heavy machinery, or do other dangerous activities.
• Problems controlling your body temperature so that you feel too warm. Avoid getting overheated or dehydrated while taking CAPLYTA.
• Difficulty swallowing that can cause food or liquid to get into the lungs.

The most common side effects of CAPLYTA include sleepiness, dizziness, nausea, and dry mouth.

These are not all the possible side effects of CAPLYTA. Tell your healthcare provider if you have or have had heart problems or a stroke, high or low blood pressure, diabetes, or high blood sugar, problems with cholesterol, have or have had seizures (convulsions), kidney or liver problems, or a low white blood cell count. CAPLYTA may cause fertility problems in females and males. You should notify your healthcare provider if you become pregnant or intend to become pregnant while taking CAPLYTA. CAPLYTA may cause abnormal involuntary movements and/or withdrawal symptoms in newborn babies exposed to CAPLYTA during the third trimester. Talk to your healthcare provider if you breastfeed or are planning to breastfeed as CAPLYTA passes into breast milk. Tell your healthcare provider about all the medicines you're taking. CAPLYTA may affect the way other medicines work, and other medicines may affect how CAPLYTA works, causing possible serious side effects. Do not start or stop any medicines while taking CAPLYTA without talking to your healthcare provider. You are encouraged to report negative side effects of prescription drugs. Contact Intra-Cellular Therapies, Inc. at 1-888-611-4824 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules.

Please see Medication Guide, including Boxed Warnings.

References:

1. Frye MA, Calabrese JR, Reed ML, et al. Use of health care services among persons who screen positive for bipolar disorder. Psychiatr Serv. 2005;56(12):1529-1533.
2. Bipolar disorder. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/bipolar-disorders/symptoms-causes/syc-20355955. February 16, 2021. Accessed April 20, 2023.
3. National Institute of Mental Health. https://www.nimh.nih.gov/health/topics/bipolar-disorder. Accessed April 21, 2023.
4. Miller S, Dell'Ossa B, Kettera TA. The prevalence and burden of bipolar depression. J Affect Disorder. 2014; 169(1): S3-S11. Accessed April 19, 2023.
5. National Institute of Mental Health. https://www.nimh.nih.gov/health/statistics/bipolar-disorder. Accessed April 21, 2023.
6. Merikangas KR, Akiskal HS, Angst J, et al. Lifetime and 12-month prevalence of bipolar spectrum disorder in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2007;64(5):543-522.
7. CAPLYTA (lumateperone) [package insert]. New York, NY: Intra-Cellular Therapies, Inc.; 2023.

US-CAP-2300545 10/2023