Josh Cliffe

@joshuacliffe | staff

Sana Health’s New Non-Drug Clinical Trial for Neuropathic Chronic Pain

Chronic neuropathic pain (NP) is a debilitating condition that affects millions of people. One in five people live with chronic pain, and 30-40% of these individuals live with neuropathic pain. There are few treatment options for those with this condition, and many of the options come with multiple side effects which are hard to tolerate. Now, Sana Health, Inc , in partnership with Mt. Sinai Icahn School of Medicine Abilities Research Center, hopes to offer relief to those living with chronic neuropathic pain using their audiovisual Sana Device. The company has launched a study with 100 participants to assess the effectiveness of their device in treating chronic neuropathic pain. The study is fully remote with four study visits taking place over teleconferencing and the study devices mailed to the participants to use at home for 8-14 weeks. Sana health is currently completing several clinical trials . See if you qualify Chronic neuropathic pain has multiple and often severe consequences for people who live with the condition, their family members, and even society as a whole. Living with chronic pain, and especially neuropathic pain, negatively impacts people’s lives and impairs their ability to participate in day-to-day activities and to function at work or hold a job at all. In addition to the far-reaching effects on quality of life for pain patients, the cost to society is significant and lies in the range of billions of dollars . There are many causes of chronic neuropathic pain, and it is often related to underlying diseases or injuries. It can be caused by things like trauma, strokes, multiple sclerosis, shingles, diabetes, cancer, or hereditary conditions that affect the nervous system. Symptoms of neuropathic pain can occur in one part of the body or be more widespread. Patients often describe the pain they experience as burning, shooting, or electrical, and it is often accompanied by tingling or numbness. On top of physical symptoms of pain, most neuropathic pain patients experience other symptoms such as changes in mood (which can sometimes lead to depression), anxiety, sleep disorders, memory-related issues, fatigue, and generally feelings of unwellness that can be hard to define. In an interview with Liza, a Mighty Community Leader, she shared this about her experience living with chronic neuropathic pain: “I’ve lived with neuropathic pain for over a decade. It feels like forever, and I can’t remember life without pain. I am always in pain to some degree. It never goes away. It has impacted almost every part of my life, and some days I can barely get out of bed. It’s been very hard for me to find treatment that I can stay on. I always have to stop because the side effects are too much.” The Mighty is assisting Sana Health in recruitment for their user study for individuals in the U.S. diagnosed with chronic neuropathic pain who are seeking new options for symptom management. See if you’re eligible to try their device here. Learn More The device is a comfortable eye mask and earbud combination which gently uses audiovisual stimulation (AVS) to guide the wearer into a state of relaxation. Clinical data from Sana device treatments show that targeted AVS impact the central nervous system. In a 16-minute session, the Sana device provides a patented series of light and sound pulses, alternating eye-to-eye and ear-to-ear. These sessions can be done at home through an app paired to the device. As the algorithm moves through three phases the user relaxes into a deeper meditative state. At the conclusion of the treatment session with the device, individuals feel very relaxed and some fall asleep. Richard Hanbury, founder and CEO of Sana developed the Sana device after a Jeep accident in 1992 in Yemen left him with a spinal cord injury and chronic pain. After 14 months in the hospital, he was given a life expectancy of just five years. To address his own pain, he began to experiment with biometric sensors and neuromodulation patterns, hoping to recalibrate how his brain processed pain signals. The earliest prototype of the Sana device helped relieve his symptoms, and he went on to test it with the British and U.S. military services, Richard Branson’s Virgin Challenger flights, and the first Solar Impulse Flights. In 2016 he founded Sana Health to bring the technology to others who need it. “The therapeutic program provided in the 16-minute Sana session was refined over more than 25 years of trial and error by founder and inventor Richard Hanbury, in collaboration with neuroscientist Jeffrey Bower, PhD, who used EEG readings to validate the findings,” Sana Health told The Mighty. Users of the Sana device are finding relief for a range of symptoms, including pain, mood, and sleep disturbances. The device is breakthrough technology for anyone seeking non-drug treatment for symptoms related to chronic neuropathic pain. In fact, Sana has been awarded the status of Breakthrough Device Designation for the Sana device, for use in Fibromyalgia, from the Food and Drug Administration (FDA). This indicates that early testing shows that the device provides clinically meaningful improvement in symptom management for Fibromyalgia. With this status, Sana will receive priority when they submit Fibromyalgia studies for FDA approval. Users of the device speak well of its results. Jessica is a 44-year-old mother with Fibromyalgia, ankylosing spondylitis, and cancer. Her conditions left her fatigued and stressed, sleeping up to 16 hours a day at times. Regular use of the Sana device has helped her get better rest and left her with more energy. “With Sana, I am able to participate in life,” she said. “Something is centering me and something is grounding me. I can be in the moment.” The Mighty is excited about helping Sana Health recruit patients into this landmark clinical trial and about the promise of this technology to help those managing chronic neuropathic pain. If you’ve been diagnosed with chronic neuropathic pain and would like to learn more about how to participate in the study with Sana, see if you qualify here .

Community Voices
Paid content from Takeda Pharmaceuticals and Lundbeck
Angie M
Angie M @angie-m
contributor

Trying to Be Heard: My Depression As a Woman of Color

I surround myself with a strong community of family and friends who are there for me in times of joy or hardship. But sometimes I feel alone, like no one can understand what I am going through. In large part, this is because, for years, I tried to hide one very important aspect of my life — my depression. I am a woman of color, and I am a woman of faith. Within the Black and faith communities, mental health issues are stigmatized. I received my diagnosis of Major Depressive Disorder (MDD), a type of depression, nearly 30 years ago when I was in my 20s. Over the years, I have felt shame because as a Black woman of faith, I was expected to pray my depression away and find happiness in the many blessings in my life. I’ve also felt confusion because mental health is not commonly discussed in the Black community. This silence around mental health has made it difficult for me to express how I feel when talking about my MDD. I’ve described my depression as “running in quicksand.” The more I ran, the deeper I sank. I felt sad, fatigued, and had trouble thinking clearly. I lost interest in things I enjoyed doing like spending time with my family, reading, and being out in nature. I began to have suicidal thoughts and recognized that what I was experiencing wasn’t something I could fix on my own. If you are thinking about suicide, please call the National Suicide Prevention Lifeline at 1-800-273-TALK (8255). MDD manifests as a complicated set of symptoms including (but not limited to) depressed mood, loss of interest or pleasure in things once enjoyed, trouble thinking clearly, being tired often, and being restless or moving slowly. The tricky part about MDD is that each person’s experience can be different. Only a healthcare professional can diagnose and treat MDD. I started my treatment journey with my primary care physician. She discussed treatment plan options that included prescription medications and talk therapy. But I soon realized that I needed someone more specialized who focused on treating MDD, so I got a referral to a psychiatrist. Over the years, I switched psychiatric practices, tried different treatment plans, and experienced a lot of frustration because I felt like I wasn’t being heard. If you knew me, you wouldn’t know that I suffered from depression because I created a positive façade to hide my true feelings. While those around me only saw a strong, intelligent woman with wonderful family and friends, I was struggling inside to manage my MDD. I didn’t recognize who I was anymore. Then, my adult daughter was diagnosed with MDD. It was incredibly difficult to watch her struggle with her symptoms and not be able to find the words to communicate to others what she was experiencing. Yet, I knew what she was going through. Her diagnosis was a wake-up call for me. It was the moment that I knew I had to make a change and commit to prioritizing my own mental health in order to be a good example for my daughter and encourage her to do the same. It took an immense amount of courage, but I finally realized that working to get well and find the right treatment plan for me didn’t mean that I lacked faith, which is what I had been conditioned to believe. It meant that I was taking care of myself. After more than two decades following my original MDD diagnosis, I finally found a psychiatrist who understood my experience and listened to my needs. It was around this time that I remember seeing a commercial on television for an antidepressant called Trintellix ® (vortioxetine) used to treat adults with MDD, and I asked my psychiatrist about this prescription medicine . My psychiatrist helped me understand what I could expect while taking Trintellix and explained all of the risks and benefits, like how Trintellix may increase suicidal thoughts and actions in some people 24 years of age and younger (of note, Trintellix is not approved for children under 18). My doctor also advised that I should call her or get emergency help right away if I have new or worsening depression symptoms, new or sudden changes in mood, behavior, thoughts or feelings, or suicidal thoughts or actions. My doctor also said that I shouldn’t take Trintellix if I’m on a monoamine oxidase inhibitor (MAOI), or if I am allergic to vortioxetine or any other ingredients in Trintellix. Scroll below for additional Important Safety Information, including Full Boxed WARNING for Suicidal Thoughts and Actions. Click here for Medication Guide and discuss with your doctor. Along with safety considerations, my doctor went over the positive treatment results from the clinical trials in adults with MDD. In multiple short-term studies, Trintellix was shown to help reduce the overall symptoms of MDD, based on an overall score on a standardized depression rating scale compared to sugar pill. Also, she explained to me that there were no significant changes in weight seen in clinical trials with Trintellix. Some reports of weight gain have been received since product approval. I really appreciated that my doctor took the time to explain that, while antidepressants are known to be effective based on clinical trials, there are also potential side effects of these types of medications, including nausea, vomiting, weight gain, changes in sleep, treatment-emergent sexual dysfunction (TESD), and suicidal thoughts and actions. The most common side effects of Trintellix are nausea, constipation, and vomiting. Serious potential side effects include serotonin syndrome, abnormal bleeding, hypomania (manic episodes), discontinuation syndrome, visual problems, low levels of salt in your blood, and sexual problems. On my current treatment plan, I feel that my MDD is pretty well managed. I have good days and I have bad days like everyone else. Navigating my depression continues to be a complex journey and never a straight line. But that journey has led me to where I am today. I believe we need to be honest about our mental health and share our experience with those we trust and with whom we feel safe, even if the conversation is difficult. It took a lot of courage to overcome the shame and confusion that I was feeling and to speak up. But in doing so, I found my voice, as well as a doctor who was committed to helping me with my depression. There is power in the sharing of personal experiences around mental health. It’s time to use our voices to help normalize the mental health discussion and break down stigma. I want others who relate to my experience to know that MDD is not a character flaw — it’s a real disorder. I hope that by sharing my story others may realize that they have nothing to be ashamed of and should advocate for themselves to prioritize and manage their mental health. Talk to a doctor if you are experiencing the signs and symptoms of MDD and visit Trintellix.com to hear more stories like mine and learn about other patient resources. *Angie is a paid contributor for Takeda Pharmaceuticals and Lundbeck. Last name withheld to protect personal privacy. IMPORTANT SAFETY INFORMATION (continued from above) Suicidal Thoughts & Actions TRINTELLIX and other antidepressants may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. TRINTELLIX is not for use in children under 18. Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. Pay close attention to any changes, especially new or sudden changes in mood, behavior, thoughts, or feelings. Call your doctor or get emergency help right away if you have symptoms such as suicidal thoughts or actions, impulsivity, aggressive or violent actions, depression, anxiety or panic attacks, agitation, restlessness, anger, irritability, trouble sleeping, an increase in activity or talking, or other unusual changes in behavior or mood; especially if they are new, worse, or worry you. Who should not take TRINTELLIX? Do not start or take TRINTELLIX if you: are allergic to vortioxetine or any of the ingredients in TRINTELLIX take a Monoamine Oxidase Inhibitor (MAOI) have stopped taking an MAOI in the last 14 days are being treated with the antibiotic linezolid or intravenous methylene blue Do not start taking an MAOI for at least 21 days after you stop treatment with TRINTELLIX . What should I tell my doctor before taking TRINTELLIX? Before taking TRINTELLIX, tell your doctor: about all your medical and other health conditions if you are pregnant or plan to become pregnant, since TRINTELLIX may harm your unborn baby. Taking TRINTELLIX during your third trimester may cause your baby to have withdrawal symptoms after birth or to be at increased risk for a serious lung problem at birth. Tell your doctor right away if you become or think you are pregnant while taking TRINTELLIX. if you are breastfeeding or plan to breastfeed, since it is not known if TRINTELLIX passes into your breast milk Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, since TRINTELLIX and some medicines may cause serious side effects (or may not work as well) when taken together. Especially tell your doctor if you take: medicines for migraine headache called triptans; tricyclic antidepressants; opioids (such as fentanyl and tramadol); lithium; tryptophan; buspirone; St. John’s Wort; medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin; and diuretics. What are the possible side effects of TRINTELLIX? TRINTELLIX may cause serious side effects, including: Serotonin syndrome: A potentially life ‐ threatening problem that can happen when you take TRINTELLIX with certain other medicines. Call your doctor or go to the nearest emergency room right away if you have any of the following signs and symptoms of serotonin syndrome: agitation; seeing or hearing things that are not real; confusion; coma; fast heart beat; changes in blood pressure; dizziness; sweating; flushing; high body temperature; shaking, stiff muscles, or muscle twitching; loss of coordination; seizures; nausea, vomiting, diarrhea. Increased risk of bleeding: Taking TRINTELLIX with aspirin, NSAIDs, warfarin or blood thinners may add to this risk. Tell your doctor right away about any unusual bleeding or bruising. Manic episodes: Manic episodes may happen in people with bipolar disorder who take TRINTELLIX. Symptoms may include: greatly increased energy; racing thoughts; unusually grand ideas; talking more or faster than usual; severe problems sleeping; reckless behavior; excessive happiness or irritability. Discontinuation syndrome: Suddenly stopping TRINTELLIX may cause you to have serious side effects including: nausea; sweating; changes in your mood; irritability and agitation; dizziness; electric shock feeling; tremor; anxiety; confusion; headache; tiredness; problems sleeping; hypomania; ringing in your ears; seizures. Eye problems: TRINTELLIX may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your doctor if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Low levels of salt (sodium) in your blood: Low sodium levels in your blood that may be serious and may cause death can happen during treatment with TRINTELLIX. Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in your blood. Signs and symptoms may include headache; difficulty concentrating; memory changes; confusion; weakness and unsteadiness on your feet which can lead to falls. In more severe or more sudden cases, signs and symptoms include: seeing or hearing things that are not real; fainting; seizures; coma; stopping breathing. Sexual problems: Taking antidepressants like TRINTELLIX may cause sexual problems. Symptoms in males may include: delayed ejaculation or inability to have an ejaculation, decreased sex drive, or problems getting or keeping an erection. Symptoms in females may include: decreased sex drive, or delayed orgasm or inability to have an orgasm. Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with TRINTELLIX. The most common side effects of TRINTELLIX include: nausea constipation vomiting These are not all the possible side effects of TRINTELLIX. Tell your doctor if you have any side effect that bothers you or does not go away. What is TRINTELLIX (vortioxetine)? TRINTELLIX is a prescription medicine used in adults to treat a certain type of depression called Major Depressive Disorder (MDD). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1 ‐ 800 ‐ FDA ‐ 1088. For additional safety information, click here for Medication Guide and discuss with your doctor. ©2021 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved. TAKEDA and the TAKEDA logo are registered trademarks of Takeda Pharmaceutical Company Limited. TRINTELLIX is a trademark of H. Lundbeck A/S registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc. US-VOR-0915v1.0 5/22

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Navigating My Depression as a Woman of Color and Faith

I surround myself with a strong community of family and friends who are there for me in times of joy or hardship. But, sometimes I feel alone, like no one can understand what I am going through. In large part, this is because, for years, I tried to hide one very important aspect of my life — my depression. I am a woman of color, and I am a woman of faith. Within the black and faith communities, mental health issues are stigmatized. My diagnosis of Major Depressive Disorder (MDD), a type of depression, almost 30 years ago when I was in my 20s triggered a series of doctor appointments and treatment plans. Over the years, I felt shame because as a black woman of faith, I was expected to pray my depression away and find happiness in the many blessings in my life. I’ve also felt confusion because mental health is not commonly discussed in the black community; therefore, it’s difficult to find the words to fully express how I feel. I’ve described my depression as “running in quicksand.” The more I ran, the deeper I sank. I felt sad, fatigued and had trouble thinking clearly. I lost interest in things I enjoyed doing like spending time with my family, reading and being out in nature. I began to have suicidal thoughts and knew that what I was experiencing wasn’t something I could fix on my own. If you are thinking about suicide, please call the National Suicide Prevention Lifeline at 1-800-273-TALK (8255). MDD manifests as a complicated set of symptoms including (but not limited to) depressed mood, loss of interest or pleasure in things once enjoyed, trouble thinking clearly, being tired often, and being restless or moving slowly. The tricky part about MDD is that each person’s experience can be different. Only a healthcare professional can diagnose and treat MDD. I started my treatment journey with my primary care physician. She discussed treatment plan options that included prescription medications and talk therapy. But I soon realized that I needed someone more specialized who focused on treating MDD, so I got a referral to a psychiatrist. Over the years, I switched psychiatric practices, tried different treatment plans, and throughout it all experienced frustration because I felt like I wasn’t being heard. To see me, you wouldn’t know that I suffered from depression because I created a positive façade to hide my true feelings. While those around me only saw a strong, intelligent woman with wonderful family and friends, I was struggling inside to manage my MDD. I didn’t recognize who I was anymore. Then one day, my adult daughter was diagnosed with MDD. It was incredibly difficult to watch her struggle with her symptoms and not be able to find the words to communicate to others what she was experiencing. Yet, I knew what she was going through. This was a wake-up call for me. It was the moment that I knew I had to make a change and commit to prioritizing my own mental health in order to be a good example for my daughter and encourage her to do the same. It took an immense amount of courage, but I finally realized that working to get well and find the right treatment plan for me didn’t mean that I lacked faith, which is what I had been conditioned to believe. It meant that I was taking care of myself. After more than two decades following my original MDD diagnosis, I finally found a psychiatrist who understood my experience and listened to my needs. It was around this time that I remember seeing a commercial on television for an antidepressant called Trintellix ® (vortioxetine) used to treat adults with MDD and I asked my psychiatrist about this prescription medicine . My psychiatrist helped me understand what I could expect while taking Trintellix and explained all of the risks and benefits, like how Trintellix may increase suicidal thoughts and actions in some people 24 years of age and younger (of note, Trintellix is not approved for children under 18). My doctor also advised that I should call her or get emergency help right away if I have new or worsening depression symptoms, new or sudden changes in mood, behavior, thoughts or feelings, or suicidal thoughts or actions. My doctor also said that I shouldn’t take Trintellix if I’m on a monoamine oxidase inhibitor (MAOI), or if I am allergic to vortioxetine or any other ingredients in Trintellix. Scroll below for additional Important Safety Information, including Full Boxed WARNING for Suicidal Thoughts and Actions. Click here for Medication Guide and discuss with your doctor. Along with safety considerations, my doctor went over the positive treatment results from the clinical trials in adults with MDD. In multiple short-term studies, Trintellix was shown to help reduce the overall symptoms of MDD, based on an overall score on a standardized depression rating scale compared to sugar pill. Also, she explained to me that there were no significant changes in weight seen in clinical trials with Trintellix. Some reports of weight gain have been received since product approval. I really appreciated that my doctor took the time to explain that, while antidepressants are known to be effective based on clinical trials, there are also potential side effects of these types of medications, including nausea, vomiting, weight gain, changes in sleep, treatment-emergent sexual dysfunction (TESD), and suicidal thoughts and actions. The most common side effects of Trintellix are nausea, constipation, and vomiting. Serious potential side effects include serotonin syndrome, abnormal bleeding, hypomania (manic episodes), discontinuation syndrome, visual problems, low levels of salt in your blood, and sexual problems. On my current treatment plan, I feel that my MDD is pretty well managed. I have good days and I have bad days like everyone else. Navigating my depression continues to be a complex journey and never a straight line. But that journey has led me to where I am today. I believe we need to be honest about our mental health and share our experience with those we trust and with whom we feel safe, even if the conversation is difficult. It took a lot of courage to overcome the shame and confusion that I was feeling. But in doing so, I found my voice, as well as a doctor who was committed to helping me with my depression. There is power in the sharing of personal experiences around mental health. It’s time to use our voices to help normalize the mental health discussion and break down stigma. I want others who relate to my experience to know that MDD is not a character flaw – it’s a real disorder. I hope that by sharing my story others may realize that they have nothing to be ashamed of and should advocate for themselves to prioritize and manage their mental health. Talk to a doctor if you are experiencing the signs and symptoms of MDD and visit Trintellix.com to hear more stories like mine and learn about other patient resources. *Angie is a paid contributor for Takeda Pharmaceuticals and Lundbeck. Last name withheld to protect personal privacy. IMPORTANT SAFETY INFORMATION (continued from above) Suicidal Thoughts & Actions TRINTELLIX and other antidepressants may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. TRINTELLIX is not for use in children under 18. Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. Pay close attention to any changes, especially new or sudden changes in mood, behavior, thoughts, or feelings. Call your doctor or get emergency help right away if you have symptoms such as suicidal thoughts or actions, impulsivity, aggressive or violent actions, depression, anxiety or panic attacks, agitation, restlessness, anger, irritability, trouble sleeping, an increase in activity or talking, or other unusual changes in behavior or mood; especially if they are new, worse, or worry you. Who should not take TRINTELLIX? Do not start or take TRINTELLIX if you: are allergic to vortioxetine or any of the ingredients in TRINTELLIX take a Monoamine Oxidase Inhibitor (MAOI) have stopped taking an MAOI in the last 14 days are being treated with the antibiotic linezolid or intravenous methylene blue Do not start taking an MAOI for at least 21 days after you stop treatment with TRINTELLIX . What should I tell my doctor before taking TRINTELLIX? Before taking TRINTELLIX, tell your doctor: about all your medical and other health conditions if you are pregnant or plan to become pregnant, since TRINTELLIX may harm your unborn baby. Taking TRINTELLIX during your third trimester may cause your baby to have withdrawal symptoms after birth or to be at increased risk for a serious lung problem at birth. Tell your doctor right away if you become or think you are pregnant while taking TRINTELLIX. if you are breastfeeding or plan to breastfeed, since it is not known if TRINTELLIX passes into your breast milk Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, since TRINTELLIX and some medicines may cause serious side effects (or may not work as well) when taken together. Especially tell your doctor if you take: medicines for migraine headache called triptans; tricyclic antidepressants; opioids (such as fentanyl and tramadol); lithium; tryptophan; buspirone; St. John’s Wort; medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin; and diuretics. What are the possible side effects of TRINTELLIX? TRINTELLIX may cause serious side effects, including: Serotonin syndrome: A potentially life ‐ threatening problem that can happen when you take TRINTELLIX with certain other medicines. Call your doctor or go to the nearest emergency room right away if you have any of the following signs and symptoms of serotonin syndrome: agitation; seeing or hearing things that are not real; confusion; coma; fast heart beat; changes in blood pressure; dizziness; sweating; flushing; high body temperature; shaking, stiff muscles, or muscle twitching; loss of coordination; seizures; nausea, vomiting, diarrhea. Increased risk of bleeding: Taking TRINTELLIX with aspirin, NSAIDs, warfarin or blood thinners may add to this risk. Tell your doctor right away about any unusual bleeding or bruising. Manic episodes: Manic episodes may happen in people with bipolar disorder who take TRINTELLIX. Symptoms may include: greatly increased energy; racing thoughts; unusually grand ideas; talking more or faster than usual; severe problems sleeping; reckless behavior; excessive happiness or irritability. Discontinuation syndrome: Suddenly stopping TRINTELLIX may cause you to have serious side effects including: nausea; sweating; changes in your mood; irritability and agitation; dizziness; electric shock feeling; tremor; anxiety; confusion; headache; tiredness; problems sleeping; hypomania; ringing in your ears; seizures. Eye problems: TRINTELLIX may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your doctor if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Low levels of salt (sodium) in your blood: Low sodium levels in your blood that may be serious and may cause death can happen during treatment with TRINTELLIX. Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in your blood. Signs and symptoms may include headache; difficulty concentrating; memory changes; confusion; weakness and unsteadiness on your feet which can lead to falls. In more severe or more sudden cases, signs and symptoms include: seeing or hearing things that are not real; fainting; seizures; coma; stopping breathing. Sexual problems: Taking antidepressants like TRINTELLIX may cause sexual problems. Symptoms in males may include: delayed ejaculation or inability to have an ejaculation, decreased sex drive, or problems getting or keeping an erection. Symptoms in females may include: decreased sex drive, or delayed orgasm or inability to have an orgasm. Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with TRINTELLIX. The most common side effects of TRINTELLIX include: nausea constipation vomiting These are not all the possible side effects of TRINTELLIX. Tell your doctor if you have any side effect that bothers you or does not go away. What is TRINTELLIX (vortioxetine)? TRINTELLIX is a prescription medicine used in adults to treat a certain type of depression called Major Depressive Disorder (MDD). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1 ‐ 800 ‐ FDA ‐ 1088. For additional Important Safety Information, click here for Medication Guide and discuss with your doctor. ©2022 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved. TAKEDA and the TAKEDA logo are registered trademarks of Takeda Pharmaceutical Company Limited. TRINTELLIX is a trademark of H. Lundbeck A/S registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc. Angie M. is a paid contributor for Takeda Pharmaceuticals and Lundbeck. She is a wife, mother and person living with Major Depressive Disorder, a type of depression. US-VOR-0915v1.0 03/22

Community Voices
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Living With Treatment-Resistant Depression

<p>Living With Treatment-Resistant <a href="https://dev.themighty.info/topic/depression/?label=Depression" class="tm-embed-link  tm-autolink health-map" data-id="5b23ce7600553f33fe991123" data-name="Depression" title="Depression" target="_blank">Depression</a></p>
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Community Voices

Living With Treatment Resistant Depression

<p>Living With Treatment Resistant <a href="https://dev.themighty.info/topic/depression/?label=Depression" class="tm-embed-link  tm-autolink health-map" data-id="5b23ce7600553f33fe991123" data-name="Depression" title="Depression" target="_blank">Depression</a></p>
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Katie Jackson

Finding My New ‘Normal’ With Primary Immunodeficiency

I was always a “sick kid.” This meant lots of ear infections, an asthma diagnosis in my early 20s, and more visits to doctor’s offices than I could ever count. In nursing school, I would get sick frequently. It was always brushed off because “everyone catches everything” when you’re in training. But I caught everything . I was getting sick every other month, and it always took me longer to recover. I also experienced constant, severe fatigue. I noticed I needed more sleep than my peers, and I was still tired all of the time. I was feeling progressively worse, so I started going to specialists to try and find answers. A pulmonologist decided to get my Immunoglobulin G (IgG) levels tested. This one test, which measured the function of my immune system and its ability to fight off infections changed everything. Sure enough, my levels were not very good, so he sent me to see an immunologist. If this doctor had not thought outside the box, and if I had not gotten that one test, who knows when I would have found the answers to my life-long health challenges. After seeing the immunologist, I finally got the diagnosis that explained everything I had gone through my whole life: common variable immune deficiency , a type of primary immunodeficiency (PI) disease. Living with PI simply means my body’s immune system isn’t working like it should. Unlike autoimmune disorders, where your body is fighting against itself, with PIs, your immune system has trouble fighting at all. 1 This explained why I was always more vulnerable to infections and why it always took me so long to recover. PI is rare, affecting 1 in 1,200 people in the U.S. 2 , and there are over 450 different types. 3 My family, especially my parents, was overjoyed at my diagnosis because now we knew what was going on and could do something about it. It was also nice to have validation. Doctors had accused me of faking it and had dismissed my symptoms in the past. For me, though, the relief was complicated. Getting this diagnosis meant acknowledging I was a “sick person” who had a chronic condition that wouldn’t go away. Like other people who face health challenges, it’s hard to pretend you don’t want to be “normal” every once in a while. Unfortunately, my unwillingness to accept the reality of my condition affected my decisions about treatment. I was willing to try different antibiotics, but getting immunoglobulin (Ig) therapy like my doctor recommended, which replaces the antibodies (immunoglobulins) that are missing or not working properly in people with PI, intimidated me. 4 After two years, I finally got so sick my doctor simply said, “Listen, this isn’t working.” I agreed that Ig therapy was worth trying. Despite my initial hesitation, I was relieved when we finally started. I was able to get my infusions at home (I’m a nurse, and didn’t want to spend even more time at the hospital!). My mom is a nurse too, so in the beginning it was comforting to know she’d be right there with me. The management plan that my doctor and I agreed on together has become part of my new normal, and my husband and I use my weekly infusions to spend time together. We’ll order pizza, watch a movie, and snuggle up with our dog. Now, I personally understand the importance of donating plasma. Plasma is a specific part of the blood filled with immune cells needed to fight off infections — and it’s how they can make IgG therapies. 5,6 When people donate plasma, it makes these therapies available for people like me. I want people with PI to know that even though our “normal” might look different, I got married, am looking forward to having a family, and have hobbies I enjoy. I love crafting, painting, and have a weird obsession with tie dye.  I’ve also been lucky to have such a supportive family, and the connections I’ve made through MyIgSource have been invaluable as well. MyIgSource is a unique community with helpful information, resources, and peer-to-peer support for those living with primary immunodeficiency. Now, I’m in my 30s and pregnant with my first child. When the doctor said everything was “normal” for the baby at my 20-week ultrasound, I cried tears of joy. I had never heard a doctor say that to me before. For my child, having a mom with PI will be his normal, and we’ll navigate life with it together. 1 Ballow, M., et al., (2019). Antibody Immune Deficiencies. In Patient & Family Handbook for Primary Immunodeficiency diseases (6th ed., pp. 18–20). Textbook, IDF Immune Deficiency Foundation. 2 McCusker, C., Upton, J., & Warrington, R. (2018). Primary immunodeficiency. Allergy, Asthma & Clinical Immunology, 14(S2), 2. https://doi.org/10.1186/s13223-018-0290-5 3 Immune Deficiency Foundation. About Primary Immunodeficiencies | Immune Deficiency Foundation. (n.d.). Retrieved March 16, 2022, from https://primaryimmune.org/about-primary-immunodeficiencies 4 Ballow, M., et al., (2019). Antibody Immune Deficiencies. In Patient & Family Handbook for Primary Immunodeficiency diseases (6th ed., pp. 23). Textbook, IDF Immune Deficiency Foundation. 5 Ballow, M., et al., (2019). Antibody Immune Deficiencies. In Patient & Family Handbook for Primary Immunodeficiency diseases (6th ed., pp. 13). Textbook, IDF Immune Deficiency Foundation. 6 Liebe, R. (2020, January 23). Plasma. Plasma Protein Therapeutics Association (PPTA). Retrieved March 16, 2022, from https://www.pptaglobal.org/plasma US-NON-7336v1.0 04/22