MyDepressionSpace.com

New depression treatment,TMS (transcranial magnetic stimulation), approved by FDA for Major Depressive Disorder

Last week  the FDA approved NeuroStar(R) TMS Therapy for the treatment of Major Depressive Disorder. This is the first and Only Non-systemic and Non-invasive Treatment Cleared for Patients Who Have Not Benefited From Prior Antidepressant Treatment:

 Neuronetics, Inc. is a privately-held medical device company and a leader in the field of neuromodulation. On October 8th, 2008 it announced that the U.S. Food and Drug Administration (FDA) cleared its NeuroStar TMS (Transcranial Magnetic Stimulation) Therapy system for the treatment of depression. NeuroStar TMS Therapy(R) is specifically indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode.

In clinical trials with NeuroStar TMS Therapy, these patients had been treated with a median of 4 medication treatment attempts, one of which achieved criteria for adequate dose and duration.

"In the randomized controlled trial conducted for FDA clearance, NeuroStar TMS Therapy demonstrated statistically and clinically significant treatment effects," said Phil Janicak, MD, Professor of Psychiatry at Rush University-Chicago and a Principal Investigator in the NeuroStar TMS Therapy clinical trials. "It's particularly noteworthy that these outcomes were achieved without systemic side effects, such as weight gain and sexual dysfunction."

Throughout the NeuroStar TMS Therapy studies, more than 10,000 active TMS treatments were safely performed. The following were the safety results observed:

• No systemic side effects, such as weight gain, sexual dysfunction, sedation, nausea, or dry mouth
• No adverse effects on concentration or memory
• No seizures
• No device-drug interactions
• The most common adverse event related to treatment was scalp pain or discomfort at the treatment area during active treatments, which was transient and mild to moderate in severity. The incidence of this side effect declined markedly after the first week of treatment.

COMMENT:  Reimbursement issues? The Company will have to apply The Centers for Medicare and Medicaid Services for a National Coverage Determination--a process that can take-up to a year.

National Depression screening day-October 10,2008

For 18 years, Screening for Mental Health’s National Depression Screening Day^® (NDSD) has offered health care providers evidence-based, affordable and easy-to-use mental health education and screening resources. Reaching community members with undetected and untreated mental disorders has never been more important. Studies show that most Americans wait years before they seek treatment for a mental health disorder, and many never seek treatment at all.

NATIONAL DEPRESSION SCREENING DAY

Screen and educate members of your community for depression, posttraumatic stress disorder (PTSD)

Educate clinicians about best practices for assessment and treatment bipolar disorder, and    generalized anxiety disorder    

Refer those in need of treatment to mental health services

Screening for Mental Health, Inc., is a non-profit organization that does not provide medical, psychological, diagnostic or treatment services. If you or someone you know is in crisis and need immediate help, please go to the nearest emergency room, call 911, or 1-800-273-TALK (8255).

O.J. Simpson is now gulity on thirteen counts and will spend the rest of his life in jail. Was his behavior at the Las Vegas hotel manic or bipolar?

If a "normal" person is the victim of a crime such as having their   personal belongings stolen, he/she would simply call the authorities to retrieve the items. But not O.J. Simpson. He exhibited all the classic symptoms of manic or bipolar behavior when he orchestrated  a raid  at a  Las Vegas hotel room for the return of his personal items. Why didn't he pick-up the phone, call the police and report a robbery?:

Thirteen years to the day after being acquitted of killing his wife and her friend in Los Angeles, O.J. Simpson was found guilty of robbing two sports-memorabilia dealers at gunpoint in a Las Vegas hotel room. The 61-year-old former football star was convicted of all 12 counts late Friday after jurors deliberated for more than 13 hours. He released a heavy sigh as the charges were read and was immediately taken into custody.

Had he simply dialed three numbers (911) to report a robbery, O.J. Simpson would be a free man today. Simpson foolishly thought he was invincible.

What are the Symptoms of Manic or Bipolar Behavior?

Impulsiveness, poor judgment

Reckless behavior such as spending sprees, impulsive business decisions, erratic driving and sexual indiscretions

Delusions of granduer and hallucinations

Grandiose thoughts, extreme sense of self-importance

Excessive irritability, aggressive behavior

Inability to understand the consequences of inappropriate behavior

The consequences of manic behavior are perfectly illustrated in the below picture.

COMMENT: Don't let this happen to you or a loved one. However, I do hope this brings well needed closure for the Goldman and Brown families.

Cyberonics is unable to get partner for its depression therapy; vagus nerve stimulation ( VNS).

Today Cyberonics Inc., the manufacturer of the vagus nerve stimulator,  announced some very disappointing, but not surprising news:

Medical device maker Cyberonics Inc. said Wednesday it still has not found a partner for its depression system and reaffirmed its position that it will not conduct additional studies until it has found a collaborator. The company said it is now evaluating alternative actions that could help maintain regulatory approval while lowering its investment in the product.

We are in the fourth-year of FDA approval of vagus nerve stimulation therapy to treat major depressive disorder. In May of 2007, The Centers for Medicare and Medicaid Services  concluded that vagus nerve stimulation was not necessary to treat resistant depression, issued a final and binding National Coverage Decision of no coverage.

Vincent van Gogh's 1890 painting: On the Threshold of Eternity

For current VNS patients, the Company did announce "we remain committed to supporting patients and clinical partners." That is the good news. If you or a loved one currently has  the implant for depression, please do not worry. The President and Chief Executive of Cyberonics Inc.,  Daniel Moore,  has made it clear that you will continue to receive appropriate medical and clinical support.

It is also important to remember that Cyberonics is fully committed to its very profitable epilepsy business. The procedure for depression is identical to that of the procedure for epilepsy. The device is identical,  the surgery is identical and the programming of the device is identical.

Cyberonics employs over 440 people, has implanted 52,000 patients( epilepsy and depression) nationwide and has relationships with doctors in all fifty states. In the short term, this news is not really news. In the very long term, this news may ultimately be the catalyst for a much larger Company to conduct another trial for treatment-resistant depression--- a large, very well designed, double-blind, placebo-controlled with a long acute( blinded) period. Ideally I think the "blinded" portion of any future trial should be nine months.

For many patients( including me), there is a dramatic improvement in mood and depression that "kicks-in" after six months of stimulation. The design of the original trial had only an eight week fixed dosage of VNS, which apparently was one of the reasons for the  less than stellar results reported during the acute( short-term) portion of the trial. Secondly, scientists are currently researching dosing strategies as well as methods to determine appropriate patients for VNS Therapy(TM).

More on this tomorrow.