Depression is a serious medical illness affecting more than 16 million American adults every year, 6.7% of all U.S. adults1. Often a debilitating disorder, depression results in a persistent state of sadness or loss of interest or pleasure which interferes with an individual’s thoughts, behavior, mood, and physical health. 

In 2010, the economic burden of depression was estimated at $210 billion in the US2 and depression was the second leading cause of disability, accounting for almost 20% of all years of life lost to disability and premature death.3

Depression can be a lethal disease. In fact, each year in the US, over 44,000 people die by suicide, 60% of whom suffer from depression.4, 5 Overall, women are almost twice as likely as men to suffer from depression; however, some experts feel that depression in men is under-reported.6 Depression has no racial, ethnic or socioeconomic boundaries. About two-thirds of those who experience an episode of depression will have at least one other episode in their lives.

While the exact cause of depression is not known, the leading scientific theory is that depression is caused by decreased activity in the neural networks of the brain that regulate emotion and motivation. Increasing levels of neurotransmitters in the brain has been found to reactivate these neural networks, or create new networks. Neurotransmitters are chemical messengers that send signals between brain cells. Depression is most often treated with antidepressant medications. It is believed that antidepressant medications work by increasing the levels of these neurotransmitters. 

More than 4 million patients do not receive adequate benefit from antidepressants and/or cannot tolerate the side effects caused by them. For these patients, they need a new way back.

References:

1. Center for Behavioral Health Statistics and Quality. (2016). 2015 National Survey on Drug Use and Health: Detailed Tables. Substance Abuse and Mental Health Services Administration, Rockville, MD.
2. Greenberg PE, et al. The Economic Burden of Adults With Major Depressive Disorder in the United States (2005 and 2010). J Clin Psychiatry. 2015; 76(2):155-162.
3. US Burden of Disease Collaborators. The state of US health, 1990-2010: burden of diseases, injuries, and risk factors. JAMA, 310(6): 591-608, 2013.
4. Arias E, Heron M, Xu JQ. United States life tables, 2012. National vital statistics reports; vol 65 no 8. Hyattsville, MD: National Center for Health Statistics. 2016.
5. Courtet, P. and Lopez-Castroman, J. (2017), Antidepressants and suicide risk in depression. World Psychiatry, 16: 317-318. doi:10.1002/wps.20460
6. Martin LA, Neighbors HW, Griffith DM. The Experience of Symptoms of Depression in Men vs Women Analysis of the National Comorbidity Survey Replication. JAMA Psychiatry. 2013;70(10):1100-1106. doi:10.1001/jamapsychiatry.2013.1985

What is major depression?

What causes depression?

How prevalent is depression?

Is depression a serious disease?

Is there a cure for depression?

Are some people more likely to become depressed than others?

What are the symptoms of depression?

What are the current approved treatments for depression?

What is transcranial magnetic stimulation?

What is major depression?

Major depressive disorder is a condition which lasts two or more weeks and interferes with a person’s ability to carry out daily tasks and enjoyed activities that previously brought pleasure. This condition affects approximately 16 million American adults, or about 6.7 percent of the U.S. population age 18 and older. 1

What causes depression?

The exact cause of depression is not known, but leading research in Neuroscience points to an imbalance in the brain’s neurotransmitters as the manifestation of depression. Neurotransmitters are chemical messengers that send signals between brain cells. A person’s genetic make-up and life history may also determine a person’s tendency to become depressed.

How prevalent is depression?

In 2016 a study conducted by the Center for Behavioral Health Statistics and Quality reported that major depressive disorder will affect approximately 16 million American adults (about 6.7% of the US population) in a given year. 1

Is depression a serious disease?

Yes. The National Institute of Mental Health maintains that, “Depressive illness can often interfere with normal functioning and cause pain and suffering not only to those who have the disorder, but to those who care about them. Serious depression can destroy family life as well as the life of the ill person.” A national study of depression found that nearly all the respondents who reported a major depressive disorder also reported that their social and/or work lives were negatively affected by their illness.1 In 2010, the economic burden of depression was estimated at $210 billion in the US2 and depression was the second leading cause of disability, accounting for almost 20% of all years of life lost to disability and premature death.3 Depression can also be a lethal disease. Each year in the US, over 30,000 people die by suicide, 60% of whom suffer from depression. 4, 5

Is there a cure for depression?

There is no known cure for depression but with effective treatment, many patients can remain symptom free.

Are some people more likely to become depression than others?

There are many factors which can predispose certain people towards depression more than others. However, the exact causation between these factors and the occurrence of depression are still being researched and debated. Some of these risk factors include:

• Suffering from certain medical illnesses such as stroke, heart attack, cancer, Parkinson’s disease, and hormonal disorders
• Hereditary predispositions to depression passed through genes.
• Experiencing a serious loss, difficult relationship, financial problem, or any stressful change in life pattern.
• Taking certain medications that may increase vulnerability to depression

What are the symptoms of depression?

The symptoms of depression can vary from person to person. However, depression is generally observed as being a persistent state of sadness or a loss of the ability to experience pleasure. Those experiencing depression often lose interest in everyday activities or hobbies that were once enjoyed.

According to the standard diagnosis guide (DSM-V) published by the American Psychiatric Association, depression is diagnosed when an individual is experiencing either a depressed mood or a loss of interest or pleasure plus four or more of the following depression symptoms during the same two-week period:

• Significant weight loss (when not dieting) or weight gain (a change of more than five percent of body weight in a month)
• Significant increase or decrease in appetite
• Excessive sleepiness or insomnia
• Agitation and restlessness
• Fatigue or loss of energy nearly every day
• Feelings of worthlessness or excessive and inappropriate guilt nearly every day
• Diminished ability to think, concentrate, or make decisions
• Recurrent thoughts of death or suicide

If you feel you are experiencing any of these depression symptoms, contact your doctor and speak with them about your depression treatment options.

What are the current approved treatments for depression?

Depression is most often treated with psychotherapy (talk-therapy) and antidepressant medications administered together. Although antidepressants can be effective for many patients, they do not work for everybody. Additionally, since antidepressants are typically taken by mouth, they circulate in the bloodstream throughout the body, often resulting in unwanted side effects. More than 4 million patients do not receive adequate benefit from antidepressant medications and/or cannot tolerate the side effects caused by them. For these patients, alternative treatments are available which usually involve the use of a medical device. These treatments include: transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT) and vagus nerve stimulation (VNS).

What is Transcranial Magnetic Stimulation?

Transcranial magnetic stimulation (TMS) uses electromagnetic pulses to stimulate nerve cells in the area of the brain thought to control mood. These pulses are thought to have a positive effect on the brain’s neurotransmitters levels. Treating depression with transcranial magnetic stimulation, may provide an alternative depression treatment for those who have not benefited from prior antidepressant medication.

References:

1. Center for Behavioral Health Statistics and Quality. (2016). 2015 National Survey on Drug Use and Health: Detailed Tables. Substance Abuse and Mental Health Services Administration, Rockville, MD.
2. Greenberg PE, et al. The Economic Burden of Adults With Major Depressive Disorder in the United States (2005 and 2010). J Clin Psychiatry. 2015; 76(2):155-162.
3. US Burden of Disease Collaborators. The state of US health, 1990-2010: burden of diseases, injuries, and risk factors. JAMA, 310(6): 591-608, 2013.
4. Arias E, Heron M, Xu JQ. United States life tables, 2012. National vital statistics reports; vol 65 no 8. Hyattsville, MD: National Center for Health Statistics. 2016.
5. Courtet, P. and Lopez-Castroman, J. (2017), Antidepressants and suicide risk in depression. World Psychiatry, 16: 317-318. doi:10.1002/wps.204

Depression symptoms are traditionally treated with psychotherapy and antidepressant medications, and these treatments are considered the first-line treatments. Specifically in the case of antidepressants, these medications are thought to increase the levels of under-performing neurotransmitters in the brain. While these changes have a positive effect for many, medications do not work for all and even when medication does work, there can still be some serious side effects to consider.

Antidepressant medications are chemicals that are typically taken by mouth. These chemicals circulate in the bloodstream throughout the body, often resulting in unwanted side effects such as weight gain, sexual problems, upset stomach, sleepiness, and dry mouth. Even after all this, it can take days or weeks for a medication to circulate through the body and reveal whether it is effective for a patient.

More than 4 million patients do not receive adequate benefit from antidepressants and/or cannot tolerate the side effects caused by them. For these patients, alternative treatments for depression are available. These therapies have proven to work in some people that do not receive benefit from antidepressants and/or cannot tolerate the side effects caused by them. These treatments include: Transcranial Magnetic Stimulation (TMS), Electro Convulsive Therapy (ECT) and Vagus Nerve Stimulation (VNS).

Recent research into Transcranial Magnetic Stimulation (TMS) has created a new alternative treatment for depression. It is believed that by focusing electromagnetic pulses at specific regions of the brain, TMS activates and raises the levels of neurotransmitters in areas shown to be under-performing in people suffering from depression. TMS is a very promising treatment for depression and seeks to be a viable therapy for those who have not benefited from prior antidepressant medications.

For decades, researchers have sought safe and effective treatments for depression. However, there is no single depression treatment which has been proven to work for everyone. Depression is often treated with antidepressant medications; however, alternative treatments for depression are available. These depression therapies have been shown to work in people who do not receive benefit from medications or cannot tolerate the side effects caused by them. One alternative therapy for the treatment of depression is transcranial magnetic stimulation (TMS). NeuroStar TMS Therapy was recently FDA-cleared for patients suffering from depression who have not achieved satisfactory improvement from prior antidepressant medications.

Transcranial Magnetic Stimulation (TMS)

Transcranial magnetic stimulation therapy uses short pulses of magnetic fields to stimulate nerve cells in the area of the brain thought to control mood. It is sometimes referred to as rTMS which stands for repetitive transcranial magnetic stimulation. TMS patients receiving TMS Therapy remain awake and alert during the procedure.

NeuroStar TMS Therapy ® is an outpatient procedure. The typical treatment course consists of at least 5 treatments per week over a 4-6 week period for 20-30 treatments. Each depression treatment session lasts approximately 19-37 minutes, depending on what the doctor determines is the correct protocol. NeuroStar TMS Therapy is:

• Non-invasive, meaning that it does not involve surgery. It does not require any anesthesia or sedation, as the patient remains awake and alert during the treatment.
• Non-systemic, meaning that it is not taken by mouth and does not circulate in the bloodstream throughout the body.
• FDA cleared for patients who have not benefited from prior antidepressant treatment.

Through a magnetic coil, the NeuroStar TMS Therapy system generates highly concentrated, magnetic fields which turn on and off very rapidly. These magnetic fields are the same type and strength as those produced by a magnetic resonance imaging (MRI) machine.

The treatment coil is applied to the head above the left prefrontal cortex. This part of the brain is involved with mood regulation, and therefore is the location where the magnetic fields are focused. These magnetic fields do not directly affect the whole brain; they only reach about 2-3 centimeters into the brain directly beneath the treatment coil. As these magnetic fields move into the brain, they produce very small electrical currents. These electrical currents activate cells within the brain which are thought to release neurotransmitters like serotonin, norepinephrine, and dopamine. Since depression is thought to be the result of an imbalance of these chemicals in the brain, TMS can restore that balance and, thus, relieve depression.

What is TMS Therapy?

How does TMS Therapy work?

Is TMS Therapy covered by my insurance?

Is TMS Therapy a good alternative for patients who cannot tolerate the side effects associated with antidepressant medications?

Is TMS Therapy like other alternative therapies which use magnets to treat some illnesses?

Is TMS Therapy like electroconvulsive therapy (ECT)?

What is a typical course of TMS treatment?

What are the potential risks of NeuroStar TMS Therapy?

Can TMS Therapy cause brain tumors?

Does TMS Therapy cause memory loss?

Is TMS Therapy uncomfortable?

How long does the antidepressant effect last? Will I need any therapy beyond the first treatment regimen?

Can I also take antidepressant(s) if I am receiving TMS Therapy?

Does FDA-clearance of the NeuroStar TMS Therapy system mean that all TMS devices are cleared for use in major depression within the United States?

What is TMS Therapy?

TMS stands for transcranial magnetic stimulation. It is used to treat depression by stimulating the brain non-invasively using electromagnetic fields, similar to those produced by an MRI machine. During TMS Therapy, a magnetic field is administered in very short pulses to the part of the brain that research has demonstrated to be associated with depression. The typical initial course of treatment is about 19-37 minutes daily over 4-6 weeks.

How does TMS Therapy work?

The NeuroStar TMS Therapy system uses short pulses of magnetic fields to stimulate the area of the brain that is thought to function abnormally in patients with depression. The magnetic field produces an electric current in the brain that stimulates the brain cells (neurons). This results in changes that are thought to be beneficial in the treatment of depression.

Is NeuroStar TMS therapy covered by my insurance?

It usually takes time for healthcare insurers to establish coverage policies for newly approved treatments such as NeuroStar TMS. However, many commercial and Medicare plans have recognized the effectiveness of treating depression with TMS Therapy and now cover TMS as part of their plans. See here for a full list of insurance plans that cover TMS

Is TMS Therapy a good alternative for patients who cannot tolerate the side effects associated with antidepressant medications?

NeuroStar® is non-systemic (does not circulate in the blood throughout the body), so it does not have side effects such as weight gain, sexual dysfunction, nausea, dry mouth, sedation, etc. The most common side effects reported during clinical trials were headache and scalp discomfort – generally mild to moderate – occurring less frequently after the first week of treatment.

Is TMS Therapy like other alternative therapies which use magnets to treat some illnesses?

No. TMS Therapy involves a unique method of using pulsed magnetic fields for therapeutic benefit. The intensity of the magnetic field is similar to that of the magnetic fields used in magnetic resonance imaging, or MRI. These techniques differ radically from the popular use of low intensity, static magnetic fields. These products deliver weak and undirected static fields that are not capable of activating brain cells.

Is TMS Therapy like electroconvulsive therapy (ECT)?

No, the two procedures are very different. While both are effective in the treatment of depression, there are many differences in safety and tolerability.

During TMS Therapy, patients sit in a chair and are awake and alert throughout the entire 19-37 minute procedure – no sedation is used with TMS Therapy. Patients can transport themselves to and from treatment.

In over 10,000 active treatments with the NeuroStar TMS Therapy system in clinical trials, no seizures were observed. TMS Therapy was also shown to have no negative effects on memory function in these studies.

In contrast, “shock therapy,” or electroconvulsive therapy (ECT), intentionally causes a seizure. Patients receiving ECT must be sedated with general anesthesia and paralyzed with muscle relaxants. Recovery from an ECT treatment session occurs slowly, and patients are usually closely monitored for minutes or a even few hours after a treatment.

Short-term confusion and memory loss are common with ECT, and long-term disruptions in memory have been shown to occur and may persist indefinitely in some people. Because of the side effects associated with ECT, a significant amount of caregiver support is required

What is a typical course of treatment with NeuroStar TMS Therapy?

A typical course of TMS Therapy is 5 times per week for 19-37 minutes sessions, depending on what the doctor determines is the correct protocol, over 4-6 weeks. Any additional treatments are based on clinical judgment.

What are the potential risks of NeuroStar TMS Therapy?

NeuroStar TMS Therapy has been shown to be well tolerated and the Neurostar TMS Therapy system has been demonstrated to be safe in clinical trials. Throughout over 10,000 active treatments performed in clinical trials, the most commonly reported side effect related to treatment was scalp discomfort during treatment sessions. This side effect was generally mild to moderate, and occurred less frequently after the first week of treatment. Less than 5% of patients treated with NeuroStar TMS Therapy discontinued treatment due to side effects.

In NeuroStar clinical trials, over 10,000 TMS treatments demonstrated its safety, with no occurrence of seizures. However, there is a small risk of a seizure occurring during treatment. This risk is no greater than what has been observed with oral antidepressant medications.

While NeuroStar TMS Therapy has been demonstrated to be effective, not all patients will benefit from it. Patients should be carefully monitored for worsening symptoms, signs or symptoms of suicidal behavior, and/or unusual behavior. Families and caregivers should also be aware of the need to observe patients and notify their treatment provider if symptoms worsen.

Can NeuroStar TMS Therapy cause brain tumors?

No, NeuroStar TMS Therapy uses the same type and strength of magnetic fields as MRIs (magnetic resonance imaging), which have been used in tens of millions of patients around the world and have not been shown to cause tumors. The magnetic energy used in a full course of TMS Therapy is a small fraction of just one brain scan with an MRI.

Does TMS Therapy cause memory loss?

No, the NeuroStar TMS Therapy system was systematically evaluated for its effects on memory. Clinical trials demonstrated that NeuroStar TMS Therapy does not result in any negative effects on memory or concentration.

Is TMS Therapy uncomfortable?

Not always, the most common side effect related to treatment was scalp discomfort during treatment sessions. This side effect was generally mild to moderate, and occurred less frequently after the first week of treatment.

If necessary, you can treat this discomfort with an over-the-counter analgesic. If these side effects persist, your doctor can temporarily reduce the strength of the magnetic field pulses being administered in order to make treatment more comfortable.

Less than 5% of patients treated with NeuroStar TMS Therapy discontinued treatment due to side effects.

How long does the antidepressant effect last? Will I need any therapy beyond the first treatment regimen?

NeuroStar TMS is the only TMS system with the durability of its effects established over 12 months. In a clinical trial, 2 out of 3 patients who had either responded to treatment or completely remitted their depression symptoms reported 12 months later that they remained at the level they were at the end of the trial. Additionally, after the trial, only 1 in 3 patients needed to return for ‘maintenance’ TMS sessions.

Can I also take antidepressant(s) if I am receiving NeuroStar TMS Therapy?

Yes. In clinical trials, NeuroStar TMS Therapy was safely administered with and without other antidepressant medications.

Does FDA-clearance of the NeuroStar TMS Therapy system mean that all TMS devices are cleared for use in major depression within the United States?

No, the NeuroStar TMS Therapy system is the first TMS device to be cleared by the U.S. Food and Drug Administration (FDA) for the treatment of major depression.

The NeuroStar TMS Therapy system is also the first TMS device to have been evaluated in a large, multicenter, controlled clinical trial, as well as the only TMS system with the durability of its effects over 12 months established.