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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.

Brexanolone Infusion Rapidly Relieves Postpartum Depression

NEW YORK (Reuters Health) – A 60-hour infusion of brexanolone significantly improves symptoms in women with postpartum depression, according to results from two phase 3 trials.

The results “confirm and extend the previous work showing that brexanolone has a rapid onset of action that is unlike anything else currently available,” said Dr. Samantha Meltzer-Brody from the University of North Carolina at Chapel Hill School of Medicine.

“Further, the robust treatment response to a single 60-hour infusion was maintained through the 30 days of follow-up in this clinical trial,” she told Reuters Health by email.

Brexanolone is a proprietary, intravenous formulation of allopregnanolone, an endogenous progesterone metabolite that appears to modulate gamma-aminobutyric acid (GABA) receptors. Brexanolone showed rapid and durable antidepressant effects during an earlier phase 2 clinical trial.

Dr. Meltzer-Brody and colleagues investigated the efficacy and safety of brexanolone injection in 246 women with moderate to severe postpartum depression in two randomized, placebo-controlled phase 3 trials at 30 U.S. centers.

In study 1, Hamilton Rating Scale for Depression (HAM-D) total scores decreased to a significantly greater extent at the end of the 60-hour infusion in the group receiving brexanolone 60 mcg/kg per hour (mean reduction, 19.5 points) and in the group on brexanolone 90 mcg/kg per hour (17.7 points) than in the placebo group (14.0 points).

Similarly, in study 2, HAM-D scores improved significantly more in the higher-dose group (mean, 14.6 points) than in the placebo group (12.1 points), the team reports in The Lancet, online August 31.

Depression scores had not returned to baseline by day 30 in any of the brexanolone groups and remained significantly lower in both treatment groups than in the placebo group of study 1 at day 30.

Remission (HAM-D total score 7 or less) and response (reduction in HAM-D total score of at least 50%) rates were higher in the brexanolone groups than in the placebo groups.

Brexanolone injection was generally well tolerated in both studies, with dizziness and somnolence occurring more frequently in women receiving brexanolone injection than placebo.

“If approved, brexanolone would be a powerful new tool that would act quickly (within a few days or less) to treat women suffering with postpartum depression (PPD),” Dr. Meltzer-Brody said. “PPD can often be debilitating to women and their families, and a rapidly acting treatment would be a most welcome addition to current options. It is important for symptoms of PPD to be quickly treated, as this can prevent long-term adverse consequences including impairing mother-child bonding and attachment.”

Dr. Michael E. Silverman from Icahn School of Medicine at Mount Sinai, in New York CIty, who has researched various aspects of postpartum depression, told Reuters Health by email, “Probably the most important finding is the reported 60-hr effect of brexanolone infusion treatment. This is a potentially important finding given the time course of currently available psychopharmacologic treatments for depression.”

“The fact that brexanolone must be infused over an extended period of time and cannot be taken orally complicates matters as a first-line treatment option,” he said.

He pointed out a number of issues complicating the interpretation of this report: why did the lower dosage of brexanolone appear to have a larger effect? Why did study 2 not show a significant 30-day effect of brexanolone? The placebo effect in both studies was considerable. These issues, he said, require further study.

“Brexanolone as a treatment for PPD is a potentially exciting avenue; indeed, as clinicians we could use more options in our treatment toolbox,” Dr. Silverman said. “I’m hopeful additional work, including replications of the above study to clarify the reported findings, will continue to be conducted.”

Sage Therapeutics, Inc. funded the studies and employed several of the authors. Dr. Meltzer-Brody reports financial ties to the company.

SOURCE: https://bit.ly/2Mr9xwc

Lancet 2018.

September 17, 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.

Another FDA clearance for MagVenture: 3 minute depression treatment

August 2018: MagVenture’s Theta Burst solution is now FDA cleared.

For people suffering from severe depression, the road to remission just became a lot shorter: The treatment is known as Transcranial Magnetic Stimulation (TMS), and MagVenture has now, as the only company in the US, received FDA clearance for a newer and much faster treatment protocol which will cut down treatment time to just 3 minutes per session*. Before that, the required treatment time per session was up to 37 minutes.

TMS has been FDA cleared for treatment-resistant major depressive disorder since 2008. Since then, over 1,000 psychiatric clinics have emerged in the US. Most private health insurance companies also cover the treatment. The relatively long treatment sessions have, however, not only limited the treatment capacity for TMS practices but also hindered a more widespread dissemination. Until now, each session has been up to 37 minutes long, with 20-30 sessions needed in total. The new treatment form, which is known as Theta Burst Stimulation (TBS), offers one significant advantage: Time. A TBS treatment session lasts only 3 minutes and thus has the potential to revolutionize the clinical field of TMS.

“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. We are happy and proud to be the first in the US to receive an FDA clearance for this revolutionary treatment which is backed up by substantial scientific evidence. Our current treatment system, MagVenture TMS Therapy, can easily be 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,” says Kerry Rome, Vice President of Sales, MagVenture Inc.

The new FDA cleared treatment protocol, currently only offered by MagVenture, is based on a new clinical study, named the THREE-D trial, and led by a partnership of three leading research hospitals in Canada (CAMH, UHN, and UBC). It is the largest, double-blinded, randomized TMS trial to date, with 414 participants suffering from major depressive disorder. Response/remission rates were 32% for those receiving the TBS protocol, whereas 49% had an improvement in their depressive symptoms. These rates are similar to the standard, longer TMS protocol. The article was published in The Lancet in 2018.

Download press release
Contact MagVenture’s US office in Atlanta

September 5, 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.

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.