What People Don’t Understand About the Reality of Living With Treatment-Resistant Depression

 

 

For the longest time, I thought I was “okay.” I thought it was normal to skip school seven or eight days a month because I couldn’t bring myself to get out of bed. I thought it was normal that I struggled to take a shower and leave the house. So many people in my life also thought I was just an “angsty” person. It wasn’t until my mom became worried about me and started taking me to doctors and psychiatrists that I began to realize I actually wasn’t totally fine – I have major depressive disorder (MDD).

Now, at 24 years old, and finally on a treatment plan that works for me, I can look back and realize that there are so many things some of my family members, teachers, friends and loved ones didn’t understand about how to support me – or others – living with MDD. We need our loved ones to sit with us and take the time to figure out if we’re really okay. The people who did that for me have made a huge difference in my life.

I didn’t really understand my depression symptoms when I started experiencing them. I just knew that it was hard for me to get out of bed unlike other people. I struggled during the day and became someone who would lie on the bathroom floor and cry because I just couldn’t get up and shower. I would sleep 18 hours a day. It was also difficult for me to make friends because my depression made it challenging to open up and relate to other people. I was constantly struggling while criticizing myself because I believed the struggle was something that everyone faced.

This was just reinforced by the many people in my life who didn’t seem concerned about what was wrong with me. Some people told my mom that my behavior was normal – something everyone goes through. People who I looked up to and thought would be able to help me used to comment on how I never attended school, and that I would probably end up a dropout. Hearing this hurt and discouraged me, especially because I always loved going to class – my childhood dream was to go to college. But hearing others express their doubts made me feel guilty that I couldn’t function the way everyone else could and really hurt my self-confidence.

When I was around 20, I checked myself into an in-patient psychiatric facility because I wanted to live a full, healthy life. Checking in to inpatient care was the only way I knew how to keep fighting. I wanted the numbness to stop and knew I needed help figuring out how to cope. It was there that I received my current diagnosis: treatment-resistant depression (TRD). My doctor told me that while I still have MDD, my type of depression is harder to treat, and typical medication may not work for me – which made sense, since I had almost run out of medications to try that actually helped me.

It was about six months after that inpatient treatment that I found a great psychiatrist who worked with me to find different treatment options. He eventually recommended that I participate in the clinical trial of a medicine called SPRAVATO^® (esketamine) CIII nasal spray. He warned me that every medicine has risks and benefits, and we discussed some of the most serious side effects of SPRAVATO^®, including sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation), breathing problems (respiratory depression and respiratory arrest), the risk of abuse and misuse, and increased risk of suicidal thoughts or actions. We also discussed the most common side effects of SPRAVATO^® (please see below for a list of all side effects of SPRAVATO^®). I told him I would let him know right away if I had new or sudden changes in how I was thinking, feeling or behaving. As with all SPRAVATO^® patients, my doctor enrolled me in the SPRAVATO^® Risk Evaluation and Mitigation Strategy (REMS) Program to keep track of any serious side effects I may experience. While this medicine will not work for everyone, it’s helped me manage my symptoms of TRD.

For Important Safety Information and BOXED WARNINGS, click here.

At first, I didn’t know what to expect when I walked into the certified SPRAVATO^® treatment center. My doctor brought me to a quiet room and supervised me while I self-administered my SPRAVATO^® treatment. Now, along with a daily oral antidepressant, I self-administer SPRAVATO^® treatments once every week, after my initial regimen of twice-a-week treatment for 4 weeks at my local certified treatment center. SPRAVATO^® must be administered under the direct supervision of a healthcare practitioner. Because it’s a nasal spray, it gives me kind of a funny taste in the back of my mouth. After administering my dose, I listen to music or catch up on reading for at least two hours while a doctor or nurse monitors me for possible side effects like increased blood pressure.

After treatment, I can’t drive, operate machinery or do anything where I need to be alert until the next day – after I’ve had a good night’s sleep.

For me, my mom was my biggest cheerleader and I know I’m lucky to have her support. She drives me to all my SPRAVATO^® appointments and keeps me company during the observation period. She has been so strong through everything, especially the times when I couldn’t be.

It hasn’t been an easy road to get to where I am today, but I’m happy with the progress I’ve made. Before, I would never leave the house, not even to get the mail, because the outside world was so overwhelming to me. But with a different treatment plan, I feel better prepared to manage my TRD. I enrolled in college and am now in my third semester – working toward my goals. I’m doing “normal things” more regularly, things like brushing my teeth, showering every day, and playing video games with friends. Now I don’t feel my whole day is dedicated to struggling with my depressive symptoms. These may seem like normal, everyday activities, but they weren’t normal at all for me before I found a treatment plan that works for me.

I view myself as a warrior for the battles I’ve fought with TRD for so long. I know others struggle and I want you to know that you aren’t alone. Share your experiences with friends and family or ask your loved ones with depression to explain what they’re feeling and why they might feel that way. Really listen to their answers. Ask questions, connect with friends and family, and openly communicate with your psychiatrist. Once I got that support and worked with my doctor to find the treatment plan that was right for me, I was able to feel more prepared to continue down a path that I’m proud of. I’m not “cured,” and I know I will continue to have good days and bad, but I would go through all the difficult times again just to get to the healthier place I’m at now.

INDICATIONS

What is SPRAVATO^® (esketamine) CIII nasal spray?

SPRAVATO^® is a prescription medicine, used along with an antidepressant taken by mouth to treat:

• Adults with treatment-resistant depression (TRD)
• Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions

SPRAVATO^® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO^® is safe or effective as an anesthetic medicine.

It is not known if SPRAVATO^® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO^® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO^®.

It is not known if SPRAVATO^® is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SPRAVATO^®?
SPRAVATO^® can cause serious side effects, including:

• Sedation and dissociation. SPRAVATO^® may cause sleepiness (sedation), fainting,  dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your  thoughts, feelings, space and time (dissociation).
  • Tell your healthcare provider right away if you feel like you cannot stay awake or if  you feel like you are going to pass out.
  • Your healthcare provider must monitor you for serious side effects for at least 2  hours after taking SPRAVATO^®. Your healthcare provider will decide when you are  ready to leave the healthcare setting.

• Respiratory depression was observed with the use of SPRAVATO^®; additionally, there were rare reports of respiratory arrest.
  • Your healthcare provider must monitor you for serious side effects for at least 2 hours (including pulse oximetry) after taking SPRAVATO^®. Your healthcare provider will decide when you are ready to leave the healthcare setting.

• Abuse and misuse. There is a risk for abuse and physical and psychological dependence  with SPRAVATO^® treatment. Your healthcare provider should check you for signs of  abuse and dependence before and during treatment with SPRAVATO^®.
  • Tell your healthcare provider if you have ever abused or been dependent on alcohol,  prescription medicines, or street drugs.
  • Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.

• SPRAVATO^® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, respiratory depression, and abuse and misuse, SPRAVATO^® is only available through a  restricted program called the SPRAVATO^® Risk Evaluation and Mitigation Strategy (REMS)  Program. SPRAVATO^® can only be administered at healthcare settings certified in the  SPRAVATO^® REMS Program. Patients treated in outpatient healthcare settings (e.g.,  medical offices and clinics) must be enrolled in the program.

• Increased risk of suicidal thoughts and actions. Antidepressant medicines 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. SPRAVATO^® is not for use in children. 
  • Depression and other serious mental illnesses are the most important causes of  suicidal thoughts and actions. Some people may have a higher risk of having  suicidal thoughts or actions. These include people who have (or have a family  history of) depression or a history of suicidal thoughts or actions.

• How can I watch for and try to prevent suicidal thoughts and actions in myself or a  family member?
  • Pay close attention to any changes, especially sudden changes, in mood, behavior,  thoughts, or feelings, or if you develop suicidal thoughts or actions.
  • Tell your healthcare provider right away if you have any new or sudden changes  in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled. Call your  healthcare provider between visits as needed, especially if you have concerns  about symptoms.

• Tell your healthcare provider right away if you or your family member have any of the  following symptoms, especially if they are new, worse, or worry you:

suicide attempts thoughts about suicide or dying

worsening depression other unusual changes in behavior or mood

Do not take SPRAVATO^® if you:

• have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal  aorta, arms and legs)
• have an abnormal connection between your veins and arteries (arteriovenous  malformation)
• have a history of bleeding in the brain
• are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO^®.

If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO^®.   

Before you take SPRAVATO^®, tell your healthcare provider about all of your medical  conditions, including if you: 

• have heart or brain problems, including:
  • high blood pressure (hypertension)
  • slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness,  or fainting
  • history of heart attack
  • history of stroke
  • heart valve disease or heart failure
  • history of brain injury or any condition where there is increased pressure in the brain
• have liver problems
• have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or  believe in things that are not true).
• are pregnant or plan to become pregnant. SPRAVATO^® may harm your baby. You should not  take SPRAVATO^® if you are pregnant.
  • Tell your healthcare provider right away if you become pregnant during treatment  with SPRAVATO^®.
  • If you are able to become pregnant, talk to your healthcare provider about methods  to prevent pregnancy during treatment with SPRAVATO^®.
  • There is a pregnancy registry for women who are exposed to SPRAVATO^® during  pregnancy. The purpose of the registry is to collect information about the health of  women exposed to SPRAVATO^® and their baby. If you become pregnant during  treatment with SPRAVATO^®, talk to your healthcare provider about registering with  the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at  https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
• are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO^®.

Tell your healthcare provider about all the medicines that you take, including prescription and  over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO^® with certain  medicine may cause side effects. 

Especially tell your healthcare provider if you take central nervous system (CNS) depressants,  psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicine. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. 

How will I take SPRAVATO^®? 

• You will take SPRAVATO^® nasal spray yourself, under the supervision of a healthcare  provider in a healthcare setting. Your healthcare provider will show you how to use the  SPRAVATO^® nasal spray device.
• Your healthcare provider will tell you how much SPRAVATO^® you will take and when you  will take it.
• Follow your SPRAVATO^® treatment schedule exactly as your healthcare provider tells you  to.
• During and after each use of the SPRAVATO^® nasal spray device, you will be checked by a  healthcare provider who will decide when you are ready to leave the healthcare setting.
• You will need to plan for a caregiver or family member to drive you home after taking  SPRAVATO^®.
• If you miss a SPRAVATO^® treatment, your healthcare provider may change your dose and  treatment schedule.
• Some people taking SPRAVATO^® get nausea and vomiting. You should not eat for at least 2  hours before taking SPRAVATO^® and not drink liquids at least 30 minutes before taking  SPRAVATO^®.
• If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at  least 1 hour before taking SPRAVATO^®.

What should I avoid while taking SPRAVATO^®? 

Do not drive, operate machinery, or do anything where you need to be completely alert after  taking SPRAVATO^®. Do not take part in these activities until the next day following a restful  sleep. See “What is the most important information I should know about SPRAVATO^®?” 

What are the possible side effects of SPRAVATO^®? 

SPRAVATO^® may cause serious side effects including: 

See “What is the most important information I should know about SPRAVATO^®?” 

Increased blood pressure.  SPRAVATO^® can cause a temporary increase in your blood  pressure that may last for about 4 hours after taking a dose. Your healthcare provider will  check your blood pressure before taking SPRAVATO^® and for at least 2 hours after you take SPRAVATO^®. Tell your healthcare provider right away if you get chest pain, shortness of  breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO^®.

Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering. 

Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.  

The most common side effects of SPRAVATO^® when used along with an antidepressant taken  by mouth include: 

feeling disconnected from yourself, your thoughts, feelings and things  around you  dizziness nausea feeling sleepy spinning sensation

decreased feeling of sensitivity (numbness) feeling anxious lack of energy increased blood pressure vomiting feeling drunk feeling very happy or excited

If these common side effects occur, they usually happen right after taking SPRAVATO^® and go  away the same day. 

These are not all the possible side effects of SPRAVATO^®.  

Call your doctor for medical advice about side effects. You may report side effects to FDA at  1-800-FDA-1088. 

Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO^® and discuss any questions you may have with your healthcare provider.

cp-170363v3

For more information about SPRAVATO^®, please visit www.spravato.com.

This information is intended for the use of patients and caregivers in the United States and its territories only. Laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States and its territories.

cp-136115v4