(BPT) – By Dr. Greg Mattingly, Physician and Principal Investigator in clinical trials for Midwest Research Group

This article is sponsored by Intra-Cellular Therapies. Dr. Mattingly provides paid consulting services to Intra-Cellular Therapies.

The Current State of Bipolar Depression

Bipolar disorder (bipolar I and II) is a common mental health condition that causes unusual changes in mood and behavior. It affects about 11 million adults in the United States. Bipolar disorder is characterized by mood episodes where patients experience both lows (depression) and highs (mania).

Patients with bipolar I or II disorder are reported to spend 70-81% of their illness in depressive episodes. The depressive episodes (the lows) with bipolar disorder are known as bipolar depression. It is more common for people living with bipolar II to experience longer depressive episodes in comparison to those living with bipolar I.

During bipolar depression, patients may feel sad or hopeless and lose interest or pleasure in most activities. Depressive episodes can be very debilitating to everyday functioning and typically occur more frequently than manic episodes.

Research shows that two out of three patients with bipolar disorder are initially misdiagnosed with major depressive disorder.

Finding a Path Forward

“The first step in treating bipolar depression is having an open conversation with your healthcare provider to explore how your symptoms have developed over time. This helps to establish an accurate diagnosis and ultimately, an appropriate treatment plan, which helps build a mutual understanding and partnership between patient and doctor in addressing the best path forward,” said Dr. Greg Mattingly, Associate Clinical Professor at Washington University School of Medicine in St. Louis, MO and a partner at St. Charles Psychiatric Associates, Midwest Research Group in St. Charles, MO.

That said, bipolar depression can be difficult for doctors to identify. The major challenge to an accurate diagnosis is differentiating bipolar depression from Major Depressive Disorder (MDD). The challenge arises, as there is often a lack of information about patient history, including previous highs (mania) or lows (depression), or the family psychiatric history. Because bipolar depression is so often misdiagnosed as Major Depressive Disorder, it can take up to 5 years to properly diagnose a patient with bipolar I and up to 10 years to properly diagnose someone with bipolar II. It is important that patients are honest and open when speaking with their care provider, so their physician can help identify the right treatment options available for them.

Identifying a Treatment Plan

“There continues to remain a significantly, underserved medical need for people struggling with bipolar depression, with only a few FDA-approved treatment options available. There remains a need for more treatments that are effective and tolerable,” said Dr. Mattingly.

CAPLYTA^® (lumateperone) is an FDA-approved option to treat bipolar depression. CAPLYTA is a prescription medicine used to treat the depressive episodes in adults with bipolar I or II, that can be taken alone or with lithium or valproate.

“While there remains a stigma attached to mental illness that causes many patients to keep their symptoms a secret, it is important for patients to know they are not alone. Finding the right treatment can be a long road, but fortunately, effective therapies, specific for bipolar depression are available. It’s all about working together with your healthcare provider to reach a proper diagnosis and find a treatment that works for you,” said Dr. Mattingly.

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 doctor 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 doctor 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 your medication.
• Problems with your metabolism including high blood sugar, diabetes, increased fat (cholesterol and triglyceride) levels in your blood and weight gain. Your doctor 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. Tell your doctor if you have symptoms of high blood sugar, which include feeling very thirsty, hungry, sick to your stomach, weak/tired or needing to urinate more than usual.
• Low white blood cell count. Your doctor 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 doctor 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 doctor 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. When taking CAPLYTA, you should not breastfeed. Tell your doctor 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.

Please see Medication Guide, including Boxed Warnings.

CAPLYTA is available in 42 mg capsules.

If you’re affected by bipolar depression, have a conversation with your doctor about CAPLYTA today.

CAPLYTA is a registered trademark of Intra-Cellular Therapies, Inc.

©2022 Intra-Cellular Therapies, Inc. All rights reserved.

US-CAP-2200213

4/22

References:

1. NIMH Bipolar Disorder. 2020. From: https://www.nimh.nih.gov/health/statistics/bipolar-disorder.shtml. Accessed: January 2021.
2. United States Census. Population estimates by age (18+): July 2019. From: https://www.census.gov/data/tables/time-series/demo/popest/2010s-national-detail.html Accessed: January 2021.
3. Forte et al. Journal of Affective Disorders. 2015; 178:71–78.
4. American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.).
5. Hirschfeld MA, et al. Journal of Clinical Psychiatry. 2003; Feb;64(2):161-174.
6. Swartz HA, Suppes T. Bipolar II Disorder: Recognition, Understanding, and Treatment. DC: APA Publishing; 2019.