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Author Archives: Robert Pollack

Robert Pollack

About Robert Pollack

Board Certified Psychiatrist in practice over 42 years. Currently focused on Genomic Assessments as part of our treatment assessments and Transcranial Magnetic Stimulation (TMS) therapy along with general adult psychiatry. Currently serve on adjunct faculties of UCF, FSU, USF and Uof F. We currently accept most Insurances.

FDA Clears 3-Minute Brain Stimulation Protocol for Depression

The US Food and Drug Administration (FDA) has approved a newer and faster treatment protocol for the MagVita repetitive transcranial magnetic stimulation (rTMS) therapy system from MagVenture, the company has announced.

The FDA first cleared the MagVitaTMS therapy system in 2015 for treatment of adults with drug-resistant major depressive disorder, as reported by Medscape Medical News.

Until now, each treatment session has lasted up to 37 minutes, with 20 to 30 sessions needed in total. With the new treatment protocol, which uses intermittent theta-burst stimulation (iTBS), a treatment session lasts only 3 minutes, the company said in a news release.

The newly approved iTBS protocol is based on results of a multicenter, noninferiority clinical trial involving 414 adults with treatment-resistant major depression who were randomly allocated to receive standard rTMS or iTBS.

The iTBS protocol was shown to be noninferior to rTMS, according to a report published in the Lancet earlier this year.

For both treatments, the number of dropouts was low, and side-effect, safety, and tolerability profiles were similar. With iTBS, the number of patients treated per day with current rTMS devices can be increased several times without compromising clinical effectiveness, the authors concluded.

“We have named it ‘Express TMS’ because that’s what it is: a treatment which is just as safe and effective for the treatment of depression as conventional TMS, only much, much faster,” Kerry Rome, MagVenture’s vice president of sales, said in the release.

Rome said the current MagVenture TMS therapy system can be easily upgraded with the new Express TMS option. “This will enable our many customers to treat far more patients per day without having to invest in another TMS device. For people needing treatment, this will also be a huge benefit, as treatment will now take up less of their time,” said Rome.

[Read the Original MedScape Post Here]

August 23, 2018
Robert Pollack

About Robert Pollack

Board Certified Psychiatrist in practice over 42 years. Currently focused on Genomic Assessments as part of our treatment assessments and Transcranial Magnetic Stimulation (TMS) therapy along with general adult psychiatry. Currently serve on adjunct faculties of UCF, FSU, USF and Uof F. We currently accept most Insurances.

U.S. Food & Drug Administration Letter Regarding Mag Vita TMS Therapy System w/Theta Burst Stimulation

This Letter Shows that TBS is FDA Approved

Tonica Elektronik A/S
Sanne Jessen
Medical Advisor
Lucernemarken 15
Farum, 3520 Dk

Re: K173620

Trade/Device Name: Mag Vita TMS Therapy System w/Theta Burst Stimulation
Regulation Number: 21 CFR 882.5805
Regulation Name: Repetitive Transcranial Magnetic Stimulation System
Regulatory Class: Class II
Product Code: OBP
Dated: July 10, 2018
Received: July 13, 2018

Dear Sanne Jessen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, “Misbranding by reference to premarket notification” (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Carlos L. Peña, PhD, MS
Division of Neurological
and Physical Medicine Devices
Office of Device Evaluation
Center for Devices and Radiological Health

[Read the Original Letter from the FDA Here]

August 15, 2018
Robert Pollack

About Robert Pollack

Board Certified Psychiatrist in practice over 42 years. Currently focused on Genomic Assessments as part of our treatment assessments and Transcranial Magnetic Stimulation (TMS) therapy along with general adult psychiatry. Currently serve on adjunct faculties of UCF, FSU, USF and Uof F. We currently accept most Insurances.

Ketamine offers lifeline for people with severe depression, suicidal thoughts

Mount Horeb, Wisconsin (CNN)

Updated 8:36 AM ET, Sat August 4, 2018

A few months ago, Alan Ferguson decided he was ready to die — for the third time. In 2014, he attempted suicide twice, and the persistent thoughts of “I need to be dead” were echoing in his brain once again. Now 54 years old, Ferguson was diagnosed with clinical depression when he was 18. Since then, he estimates, he’s been prescribed more than a dozen medications — SSRIs, SNRIs, tricyclic antidepressants — all to little or no avail.” I never got to the point that I thought, ‘OK, I’m feeling good,’ ” he said. “It was always, ‘OK, this is tolerable.’ But yet those thoughts [of wanting to die] were still there.”

In early May, Ferguson abruptly stopped taking all of his medications, quit his job and gave away his dog, Zeke. That evening, he called his sister, Linda.”It was a very good conversation,” he said. “Linda and I disagree on a lot of stuff, and that night I avoided the hot-button topics because I did not want her to have bad memories or bad thoughts of what I thought was going to end up being our last conversation.”

As luck or fate or professional intuition would have it, on a prescheduled call the very next day, Ferguson’s psychiatrist offered to refer him to a ketamine clinic in Milwaukee, about an hour and a half from his home.

Ketamine is a powerful medication used in hospitals primarily as an anesthetic, but recent scientific studieshave shown significant promise with treatment-resistant depression and suicidal ideation.

Ketamine is also used recreationally, and illegally, as a club drug known as “Special K.” It generates an intense high and dissociative effects.

“I knew of the drug from having been a police officer, so I knew of its street use — illicit use — but I’m a pretty open-minded person too, and after all the traditional medications I’ve been on with no success, I thought, ‘Well, maybe they’re on to something here with this,’ ” Ferguson said. “I wasn’t worried about trying something I had never tried before. I was worried about trying something else that wasn’t going to work.”

A Last Hope

Ferguson put off his plans to end his life for another week and made his way to Ketamine Milwaukee. The clinic operates once a week, on Fridays, in a space subleased from a weight-loss clinic in a nondescript strip mall just outside the city.

Dr. Kevin Kane, a practicing anesthesiologist, is Ketamine Milwaukee’s medical director. Referring to the fact that there haven’t been any new classes of drugs developed to treat depression in decades, Kane said that using ketamine to successfully treat the disorder’s most stubborn cases might just be “the biggest breakthrough in mental health in the last 50 years.” He estimates that it is effective for 70% of patients with treatment-resistant depression.

“It’s indicated right now for … somebody who has tried and failed at least two medications, but that’s really not who we’re seeing,” Kane said. Instead, the patients who seek his care have tried more medications than they can count. Some of them have been depressed for as long as they can remember.

“The people we’re seeing aren’t walking off the street because [they’re] feeling a little down,” he said. “They’ve been struggling without relief for a long time.”
The ketamine is administered intravenously, and relief can come quickly — in just a matter of hours.

Ferguson said he woke up the next morning anxiously anticipating his pervasive “I need to be dead” thoughts. But there were none. Mid-morning: still none. Afternoon: none. Evening: none.
“No negative thoughts!” he recalled. “My problems still existed … but things were different. My most faithful, lifelong companion was gone!”

Ferguson doesn’t like to use what he calls the “m-word”: miracle. But he will refer to the way in which ketamine worked for him a medical marvel.

Whatever you call it, the treatment doesn’t come cheap. Infusions at Ketamine Milwaukee cost $495 each, and Kane typically recommends an initial series of five to six infusions, after which patients generally return every four to six weeks for booster infusions.

Because treating depression with ketamine is an “off-label” use of the drug, it is not covered by health insurance, even when it is recommended by a doctor. Ferguson was able to scrape together enough cash for his first infusion. A good friend gave him the money for his second. And his church rallied around him and paid for his third treatment. But the results, he will tell you, are priceless.
The efficacy of Ferguson’s treatment is evident in a mood chart provided to CNN by Kane, with his patient’s permission. The black lines indicate Ferguson’s ketamine infusion dates, and the red dots are his scores on the PHQ-9 (a standardized depression questionnaire). On May 25, the day of his first infusion, Ferguson’s depression was rated “severe.” By his second infusion on June 1, it had improved to “moderate.” And by his third infusion on June 8, for the first time in his adult life, Ferguson’s depression rating measured “none.”

No More Suicidal Thoughts

Because of how quickly and how well ketamine works in some patients, some doctors have referred to it as a “save shot” for people who are suicidal.

“The ketamine may be a way to improve their mood and stop their suicidal thinking until the other antidepressants — the more standard antidepressants — have the six-week time window to work,” Kane said. “Ketamine may be just the thing that gets someone through that window until other medications get the chance to kick in.

“Sometimes, when you get so depressed that you can barely get out of bed, it’s hard to do the things that your therapist tells you to do to try and help yourself,” he said. “My hope is … that it gives people that lift in mood that allows them to start doing the other things that they know they can do to help themselves.”

Kane explained that ketamine works in depressed patients by growing synapses in areas of the brain that have atrophied, namely the hippocampus and prefrontal cortex. “If you think of it like a tree that loses its leaves in wintertime, ketamine helps grow those leaves back,” he said. “It doesn’t necessarily have to grow an entire new branch or an entire new tree. It just has to sprout new leaves.”

Moreover, the same dissociative properties that made ketamine a popular party drug are what makes the medication so effective in treating severe depression.

“Sometimes, that can be a very powerful thing, that dissociation,” Kane said. “While you’re dissociating from your body, you may be dissociating [from] your mind as well. And, you may be able to see your problems and your issues that have really been consuming you as, ‘Yes, they’re still here, but now they’re over there. They’re in a little ball in the corner, and they don’t have the power over me anymore.’

“Sometimes, people can have very profound thoughts along those lines and realizations that they can take back to their therapy session, and [it] can be a really wonderful stepping stone for them to help maintain their relief.”

Dr. Gerard Sanacora, a psychiatry professor at the Yale School of Medicine, said little to no doubt remains about the rapid, robust anti-suicidal effect of ketamine. “I think the bigger question is: How do you maintain this? And how do you decide who is the best patient to receive this?”

Clinical studies have established that immediate side effects of ketamine can include increased heart rate and blood pressure. But Sanacora said further research is needed to determine the long-term cognitive impacts of ketamine treatment, as well as to develop standard dosing guidelines.

Sanacora, who is a co-author of “A Consensus Statement on the Use of Ketamine in the Treatment of Mood Disorders,” published in the medical journal JAMA Psychiatry, said that “for the majority of people — not everybody — symptoms do tend to return after some period of time.”

At least as of now, more than two months since beginning ketamine therapy, Ferguson said he hasn’t had a single thought of taking his own life.

“It really is remarkable for me to be able to wake up and not be sorry I woke up in the morning,” he said. Still, Ferguson is keenly aware that the drug is not a miracle cure, and he will require ongoing care for the rest of his life.

After receiving a ketamine infusion in June, Ferguson thanked Kane not just for saving his life but for giving him a life he never knew was possible.

[Read the Original Post Here]

August 6, 2018
Robert Pollack

About Robert Pollack

Board Certified Psychiatrist in practice over 42 years. Currently focused on Genomic Assessments as part of our treatment assessments and Transcranial Magnetic Stimulation (TMS) therapy along with general adult psychiatry. Currently serve on adjunct faculties of UCF, FSU, USF and Uof F. We currently accept most Insurances.