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Understanding symptoms of bipolar I and bipolar II disorder

(BPT) - From the outside, Teresa's life looked great. She had a healthy family and lasting friendships. However, she didn't feel great. She had periods of panic attacks, trouble sleeping, constant fidgeting, difficulty concentrating, and the inability to feel joy.2

Teresa figured these symptoms were due to extreme depression. Even though she worked with her doctor through various treatment and management options, her symptoms continued to get worse. She started having thoughts that scared her, like, 'What if I hurt myself?'

Teresa decided it was time to see a new doctor and get another opinion. Dr. Ann Groover reviewed Teresa's symptoms and medical history over several sessions before diagnosing her with bipolar II depression.

'It turns out that the antidepressant I was taking could have actually exacerbated my bipolar disorder,' recalled Teresa. Unfortunately, Teresa's story is not unusual. Studies have shown that 3 in 4 patients with bipolar disorder are misdiagnosed, most often with major depressive disorder (MDD) (like, persistent feelings of sadness, loss of interest, and lethargy) are one of the key diagnostic features in both conditions.

Understanding bipolar depression

Bipolar disorder is a mental health condition which causes extreme changes in mood and behavior. These changes in mood, known as mood episodes, can cause patients to experience lows (bipolar depression) and highs (mania).1,3 Mood episodes can affect a person's sleep, energy, activity levels, judgement, behavior and the ability to think clearly.

The lows of bipolar, also known as 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 throughout their lives and some episodes may even last several months.4

The highs of bipolar, also known as manic or hypomanic episodes, can cause people to feel intense excitement, impulsive, unusually irritable or have an abnormal amount of increased energy.4

'I see a lot of patients who are suffering from bipolar II disorder. People with bipolar II disorder, like Teresa, may experience longer depressive episodes that can be more severe than some patients with bipolar I while not experiencing debilitating bouts of mania or needing to go to the hospital. This can make bipolar II hard to diagnose, as it can be frequently confused with major depressive disorder,' said Dr. Groover.

Treating Teresa's bipolar II depression

'Even though the diagnosis wasn't what I expected, it was a relief learning that I might be able to work with my health care provider toward a treatment and management plan that might work for me,' said Teresa. 'At a follow-up appointment with my doctor, she told me about a medication called CAPLYTA® (lumateperone).'

CAPLYTA is a prescription medication used to treat depressive episodes associated with bipolar I or bipolar II disorder in adults. CAPLYTA is a once-daily capsule that's believed to work by affecting chemicals in the brain that are involved in mood, including dopamine and serotonin. The exact way CAPLYTA works is not fully understood.

Studies have also 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 only treat bipolar I depression, CAPLYTA treats both bipolar I and bipolar II depression and can be taken alone or with lithium or valproate.

'For patients experiencing bipolar I or II depression, I often prescribe CAPLYTA. I feel that the combined efficacy and safety data along with the convenient once-a-day dosing makes CAPLYTA an excellent choice for some adult patients like Teresa with bipolar depression. Every patient's experience will be unique,' said Dr. Groover.

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. See additional important safety information below.

Finding the LYTE and breaking the stigma

'CAPLYTA has helped me light up the darkness. And I'm happy with the success I've had,' said Teresa. 'I'm grateful for my work with my doctor to talk through options that could work for me. I hope others can find the same success I did, and together we can fight the stigma of bipolar II depression.' At first, Teresa 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 the 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. Your healthcare provider should check your blood sugar, fat levels and weight before you start and periodically during treatment with CAPLYTA.

Teresa and her healthcare provider have been happy with the results. Over time, the depressive symptoms decreased with CAPLYTA. Teresa said, 'I can laugh again and feel more like myself.'

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.

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

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. CAPLYTA passes into your breast milk. Talk to your healthcare provider about the risks and benefits of breastfeeding and the best way to feed your baby during treatment with CAPLYTA. 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.

1. National Institute of Mental Health. https://www.nimh.nih.gov/health/topics/bipolar-disorder. Accessed April 21, 2023.
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. 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.
4. National Institute of Mental Health. https://www.nimh.nih.gov/health/statistics/bipolar-disorder. Accessed April 21, 2023.

©2023 Intra-Cellular Therapies, Inc. All rights reserved. CAPLYTA is a registered trademark of Intra-Cellular Therapies, Inc. All other trademarks and registered trademarks are the property of their respective owners.

US-CAP-2300251 7/2023

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