Transcript

I can laugh again: Teresa's story with bipolar II depression

(DESCRIPTION)

Video begins with white background and text in the center of the screen, and the ITCI logo centered at the bottom of the screen.

(ON SCREEN TEXT)

Hear Teresa's Story with Bipolar II Depression

[ITCI logo]

(DESCRIPTION)

The on screen text fades off screen and new text fades in. The ITCI logo remains in place.

(ON SCREEN TEXT)

The patient and healthcare provider in this video are sharing their individual experiences. They have been compensated for their time. This resource is brought to you by Intra‑Cellular Therapies.

(DESCRIPTION)

Screen cuts to Teresa packing up her gym bag getting ready to hit the gym.

(Teresa)

I often considered the feelings I had to be extreme depression. I would have panic attacks, trouble sleeping, constant fidgeting, difficulty concentrating, and an inability to find joy. Even though I worked with my doctor through various treatment and management options, my symptoms continued to get worse.

(ON SCREEN TEXT)

Teresa / Patient Advocate with Bipolar II Depression

(DESCRIPTION)

Camera cuts to Teresa making a smoothie.

(Teresa)

And I eventually had thoughts that were scary to me, like "What if I hurt myself or my son?" After seeing a new doctor and completing a mood assessment evaluation and having several sessions, I was diagnosed with bipolar II depression. It turns out that the antidepressant I was taking could have actually exacerbated my bipolar symptoms.

(DESCRIPTION)

Camera cuts to Dr. Ann Groover, MD, a psychiatry specialist, speaking to the camera. On screen text appears in the bottom left corner and then disappears.

(ON SCREEN TEXT)

Dr. Ann Groover, MD

Psychiatry Specialist

(Dr. Groover)

I see a lot of patients who are suffering from bipolar II depression. Teresa's diagnosis of bipolar II depression means she tends to experience longer depressive episodes that can be more severe than 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. The ability to differentiate bipolar I and bipolar II disorder really hinges on the identification of manic or hypomanic symptoms.

(DESCRIPTION)

Camera zooms into Dr. Ann Groover's face. On screen text appears in the bottom left corner and then disappears.

(ON SCREEN TEXT)

Bipolar I

  • 1 or more manic episodes lasting a week or longer
  • Hospitalization
  • Functional impairment and psychotic symptoms (up to 75% of the time)
(Dr. Groover)

Bipolar I is characterized by one or more manic episodes lasting a week or longer with hospitalization, functional impairment and psychotic symptoms up to 75 percent of the time, whereas bipolar II is characterized by hypomania, not mania, lasting four or more days, no hospitalizations, no psychotic symptoms and no marked functional impairment.

(DESCRIPTION)

Camera zooms out of Dr. Ann Groover's face. On screen text changes in the bottom left corner and then disappears.

(ON SCREEN TEXT)

Bipolar II

  • Hypomania, not mania, lasting 4 or more days
  • No hospitalizations
  • No psychotic symptoms and no marked functional impairment
(DESCRIPTION)

Teresa is in her room putting on her shoes.

(Teresa)

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

(DESCRIPTION)

On screen text appears at bottom of screen

(ON SCREEN TEXT)

CAPLYTA is not approved for dementia related psychosis.

CAPLYTA can increase the risk of sudden mood changes, behaviors, or suicidal thoughts. Call your healthcare provider right away if you experience these symptoms.

[CAPLYTA logo]

(Dr. Groover)

CAPLYTA is a prescription medication used to treat depressive episodes associated with bipolar I or bipolar II disorder in adults.

(DESCRIPTION)

Dr. Groover is at her desk reviewing files.

(Dr. Groover)

I consider CAPLYTA as a treatment option because I like that it's not only approved for bipolar I depression, but it's also approved for bipolar II depression. A lot of people don't realize this, but this indication is important, because there are about the same number of bipolar I patients as there are bipolar II patients. 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. But, remember, while every patient experience will be unique, it's important to monitor for potential side effects such as sudden mood changes, behaviors or suicidal thoughts. It's really important that you always talk to your healthcare provider about any concerns or questions you may have with treatment. Please see the safety information at the end of this video.

(DESCRIPTION)

Camera zooms in on Dr. Groover on the phone. On screen text appears.

(ON SCREEN TEXT)

It is important to monitor for potential side effects such as sudden mood changes, behaviors, or suicidal thoughts. Please see Important Safety Information throughout and at the end of this video.

[CAPLYTA logo]

(DESCRIPTION)

The camera cuts to shots of Teresa speaking to camera. The camera cuts to a shot of Teresa and Dr. Groover walking and talking. Text appears on screen.

(ON SCREEN TEXT)

High cholesterol and weight gain may occur, as can high blood sugar which may be fatal. Monitoring is recommended.

[CAPLYTA logo]

(Teresa)

When I talked to my doctor about CAPLYTA, I liked that it was approved to help reduce my symptoms of bipolar II depression. Getting these symptoms under control was important to me. I was really worried about the weight gain with CAPLYTA, so I was pleased to hear 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.

(DESCRIPTION)

On screen text changes. Cuts of Dr. Groover speaking to the camera interspace cuts of Teresa and Dr. Groover walking and talking.

(ON SCREEN TEXT)

Report fever, stiff muscles or confusion, which may be life‑threatening, or uncontrollable muscle movements which may be permanent.

[CAPLYTA logo]

(Dr. Groover)

I encourage all my patients to be proactive and to come to me with any questions they may have. I tell them about how CAPLYTA is approved to provide significant relief from bipolar depression symptoms and that they may see improvement in the first week, with additional relief over the course of six weeks.

Of course, everyone's experience is different, and patients should work with their healthcare providers to determine what treatment is the best choice for them. I'm also careful to talk through potential side effects with patients considering CAPLYTA as a treatment option for their bipolar depression. I make sure my patients know that it's important to call me if they experience fever, confusion, stiff or uncontrollable muscle movements, which may be life‑threatening or permanent. I also make sure my patients understand that antidepressants may increase the risk of suicidal thoughts and to call me immediately if they experience any of these thoughts or have any sudden mood changes or behaviors. And remember, CAPLYTA isn't right for everyone. CAPLYTA is not approved for dementia-related psychosis, as it can increase the risk of death or stroke. Please be sure to listen to the additional safety information towards the end of this video.

(DESCRIPTION)

On screen text changes

(ON SCREEN TEXT)

CAPLYTA is not approved for dementia-related psychosis or for people under 18. CAPLYTA can increase the risk of sudden mood changes, behaviors, or suicidal thoughts. Call your healthcare provider right away if you experience these symptoms.

[CAPLYTA logo]

(DESCRIPTION)

Camera cuts to Teresa playing Putt-Putt with friends. Text appears in the left bottom corner of the screen.

(ON SCREEN TEXT)

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

[CAPLYTA logo]

(Teresa)

Before I started CAPLYTA, I told my healthcare provider about all the medical conditions I had and medications I was taking. My doctor and I went over the potential benefits and risks of treatment, including the most common side effects such as sleepiness, dizziness, nausea and dry mouth.

In the beginning I did experience some dry mouth and nausea for a couple weeks.

Since beginning my treatment with CAPLYTA, I haven't experienced a depressive episode.

Because my symptoms are under control, I can laugh again and feel more like myself.

This was just my experience, and it's important to work with your healthcare provider to monitor any side effects you may experience.

(DESCRIPTION)

Camera cuts to Dr. Groover in her office taking notes. CAPLYTA logo is in the bottom right hand corner.

(Dr. Groover)

I always try to develop a treatment plan that addresses the whole patient.

With Teresa, I've been very pleased with the results I've seen since she started treatment with CAPLYTA.

(DESCRIPTION)

Camera cuts back to Teresa playing Putt-Putt with friends. Text appears in the left bottom corner of the screen.

(ON SCREEN TEXT)

Individual results may vary. Talk to your doctor to see if CAPLYTA might be right for you.

[CAPLYTA logo]

(Teresa)

CAPLYTA has helped light-up the darkness. And I'm happy with the success I've had. 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.

(DESCRIPTION)

Screen goes white. Previous on screen text disappears and Important Safety Information appears on screen. The CAPLYTA logo remains in the bottom right corner and the ITCI logo is in the top right corner. Important Safety Information begins scrolling as it's read on voiceover.

(DESCRIPTION)

Camera cuts to blue end card with CAPLYTA Logo

(ON SCREEN TEXT)

[CAPLYTA logo]

[ITCI logo]

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.

(DESCRIPTION)

Previous on screen text disappears and the screen becomes blue. The CAPLYTA logo is in the middle of the screen. There is legal language in the bottom left corner and the ITCI logo is in the bottom right corner.

[CAPLYTA logo]

[ITCI logo]

©2023 Intra-Cellular Therapies, Inc.

All rights reserved. US-CAP-2300618 10/23