FDA clears treatment for depression

The Post and Courier
Monday, October 13, 2008


One in 20 people suffers from depression. Half of those have an intractable type that will not respond to medicine or talking therapy.

Dr. Mark George, psychiatry professor and director of the Brain Magnetic Stimulation Laboratory at Medical University of South Carolina, has worked for more than a decade developing a new therapy to help depressed patients who are running out of options.

Clinical trial

To learn more about enrolling in a current National Institute of Mental Health study on transcranial magnetic stimulation for treatment-resistant clinical depression, click here.

The NeuroStar Transcranial Magnetic Stimulation Therapy system was developed by Malvern, Pa.-based Neuronetics with research that began at MUSC. The Food and Drug Administration cleared the device Tuesday for marketing.

The device basically is a powerful magnet that delivers focused pulses to an area of the brain that is linked to depression. The magnetic pulses stimulate the nerve cells, and through a process not fully understood, the stimulation alleviates symptoms of depression.

It is the first clearance for the marketing of a transcranial magnetic stimulation system for treatment of major depressive disorder, FDA press officer Scott McFarland said.

Previously, the arsenal to help treatment-resistant patients comprised different methods of sending electricity into the brain.

Although several methods exist today, the oldest form is electroconvulsive therapy, known as ECT or "shock therapy," which has a stigma because of its early use without anaesthesia.

In ECT, electrical currents are sent through the brain and trigger a brief seizure. No one knows exactly how the therapy works, only that changes seem to occur in the brain's chemistry in a way that can offer relief for some mental illnesses.

George, a brain imaging expert, said, "I became convinced the seizure didn't matter. The electricity or current to the brain is what matters. Maybe we can just kind of tickle those circuits without turning them off."

Early trials on the technology were carried out with funding from NARSAD, an international charity dedicated to mental health research. The most recent trial was funded by the device manufacturer, and MUSC is conducting another study sponsored by the National Institute of Mental Health.

This gentler approach has fewer side effects than electroconvulsive therapy and takes less time, George said. No anaesthesia is required and no adverse effects on concentration or memory were reported.

"It feels like hitting your head with a hard eraser," he said.

A course of treatment will cost about $6,000, compared to electroconvulsive treatments which can run up to $20,000. "The next big question is will insurance pay for these," George said.

The machine costs between $50,000 and $60,000, George said. The manufacturers have made only 15. MUSC will lease a device and begin treatments in about two months, he said.

Charleston psychiatrist James C. Ballenger recommended a handful of his patients to participate in the manufacturer's trial and described the therapy as "close to being miraculous."

Unlike other forms of brain stimulation treatments, Ballenger said, "The average psychiatrist can have this in his office."

One of his patients had been depressed for 20 years and tried every available medication with only short-term success. "He had an astoundingly positive response," Ballenger said.

In rare instances, the treatment can make changes in a patient's psychology that are unwanted, he said. For example, a bipolar patient may swing from depression to mania.

Reach Jill Coley at 937-5719 or jcoley@postandcourier.com.



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Comments

This article has  13 comment(s)

Posted by iceman1978 on October 13, 2008 at 9:44 a.m. (Suggest removal)

One thing they could do is make anti-depressants such as Zoloft and Prozac available over-the-counter.



Posted by swampwitch on October 13, 2008 at 9:56 a.m. (Suggest removal)

A family member of mine was involved with this study. It was truly amazing how much better she felt after the treatment. I hope that insurance covers this procedure soon.



Posted by GermanyXO on October 13, 2008 at 10:01 a.m. (Suggest removal)

Close friends of mine who suffer from depression self-medicate with cocaine, marijuana, or alcohol mixed with one or both, in addition to their prescription medication. One has rejected medication entirely in favor of intense exercise. Drugs available only through prescription helps control how many people self-medicate, which has proven itself life-threatening.



Posted by 512c on October 13, 2008 at 10:03 a.m. (Suggest removal)

How about we just let everyone grow their own weed, and smoke it!?!?



Posted by 512c on October 13, 2008 at 10:05 a.m. (Suggest removal)

oh crazy, this article is about eeg helmets!~ active magnetics.
wow.
go to http://openeeg.sourceforge.net/doc/



Posted by 512c on October 13, 2008 at 10:08 a.m. (Suggest removal)

well, the article isn't about open eeg, but, now it is!
just learn to solder, and make your own.
the mind is the gate, be careful as you open the door ;)



Posted by iceman1978 on October 13, 2008 at 10:10 a.m. (Suggest removal)

Germany, I wouldn't make it completely unrestricted, but I would sell it over-the-counter and regulate the sale like they do Nyquil. Here's how I would do it:

Get a prescription from your doctor in order to purchase the first bottle. When you have a prescription your name goes into the pharmacy database. For one year you can buy the medication over-the-counter, only in the dose prescribed by your doctor, and only in enough quantity to meet that dosage.

This way the patient doesn't have to keep going to the dr every three months just to get a prescription written. Instead they only have to go in once a year.



Posted by ysillyme on October 13, 2008 at 10:22 a.m. (Suggest removal)

The last sentence in the story says one negative side of this treatment is it may increase bi-polar symptoms. Shucks, the world is bi-polar (north and south) it can't be all that bad.



Posted by coolfreaknbeans on October 13, 2008 at 10:29 a.m. (Suggest removal)

I personally think that people need more therapy and less drugs. I'm not denying the life saving benefits of proper medication or alternative treatments. Too many doctors,including those NOT specializing in psychiatric care,are handing out pills like candy on Halloween. These drugs are handed out without looking into or caring about the underlying issues. A lot of doctors are giving teens pills that aren't even tested on those under 18 yrs of age. This has often resulted in disaster. Some of the anti-depressants have been known to cause suicide in teens. I know several people (in the medical field) who have witnessed this repeatedly. (kids who were suffering from minor depression and just teen social issues,get medicated and turn suicidal) These friends of mine aren't spread out over he US either. It's in one area. I'm not anti medicine at all. I just think it needs to be used as a last resort with close monitoring,not a quick fix.



Posted by iceman1978 on October 13, 2008 at 10:50 a.m. (Suggest removal)

coolfreaknbeans, Doctors hand it out like candy? If you know the name of one please tell me.

I was put on Zoloft about six months ago and have been doing very well on it. My dr told me that they would write one more prescription and after that I had to be evaluated by a psychiatrist if I wanted another one. I call to set up an appointment and work everything out with my insurance. The psychiatrist can't see me until the 30th of this month and my medication will run out by the 20th. I then call my primary care provider to explain this to them and tell them that I will need an extension on the medication to hold me over until the 30th. They refused.

I then told them that the psychiatrist could fax over a confirmation showing that I had made the appointment. They still refused. When I asked them what am I supposed to do with medication that will run out? They replied (very casually I might add) "just go see someone else"

See, not all doctors care about the well being of their patients. I'm not a physician, but I know that Zoloft is not something that you get off of cold turkey. The psychiatrist can't write one for me until she sees me, so her hands are tied, and my soon-to-be former primary care provider apparently doesn't care, or doesn't realize, that my health will potentially be in jeopardy when the medication runs out.

So now I have to set another appointment, see a different doctor, pay more money, explain to him this mess, and hope that he'll write one to cover me for a couple of weeks.

It's times like this that I wished I was still in Turkey. This could have been solved with a trip to the drug store over there.



Posted by coolfreaknbeans on October 13, 2008 at 11:06 a.m. (Suggest removal)

I feel for you iceman. Thats terrible that you are having to go through that. I'm glad you're having great success with the medication. I said before and will say it again- I'm NOT anti-psych meds,they can be life saving. One issue is GP doctors handing them out with no psychiatric follow up. But my main beef is drs. prescribing them to teens the way they have been. ( I'm assuming you aren't a teen :)



Posted by abitskeptical on October 13, 2008 at 5:54 p.m. (Suggest removal)

CFB-you are on target about GP's Rxing psychotropic drugs.

Case in point:

A friend's GP put her on an anti-depressant. The friend was depressed alright. But the GP missed that she actually is bi-polar.

It is very dangerous to treat a bi-polar condition w/ anti-depressants alone. That can trigger manic episodes. It is classic for one experiencing mania to stop taking medication (they feel so good they decide they do not need it).

When the mania passes, & it will, the depression can be worse. My friend was suffering w/ these swings & managing to keep it under wraps for a while. (mainly because she is a single parent-there was not another adult to see her behavior becoming more & more strange..which her daughters later corroborated was happening)

Eventually she went into a manic psychosis. She was almost totally disassociated from reality. Fortunately someone she trusted was able to get her to agree to a voluntary hospital admission. It took a couple of these admissions to get her regulated on the appropriate medication.

She is much better, but still is somewhat fragile.

One of the things that can happen w/ untreated bi-polar disorder is that over time the swings become more severe. This becomes a vicious cycle...the disease causing more disorder & disease. The longer is goes untreated, or the longer it is mis-treated, the more dangerous it is & the more difficult it is to successfully treat.

Psychiatrists should be the only MDs Rxing drugs to treat mood disorders.



Posted by coolfreaknbeans on October 13, 2008 at 6:42 p.m. (Suggest removal)

Absolutely abitskeptical! I also believe that GP's tend to hand out anti-depressants to people who don't need them. Who hasn't had a period a feeing a little down? Life is full of ups and downs that don't necessarily require a pill to treat.(depression is very different of course and does require treatment) I will not "out" with any Drs names. But I do know several people who have had GP's offer up pills just because they didn't (as I like to say)have sunshine and rainbows shooting out of their azz.(during their visit for a cold or something unrelated)