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Depression Comorbidities

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September 27, 2008

Surviving a financial depression; both emotionally and economically.

The newspaper headlines are gruesome for just about everyone. There is a flavor for just about everyone; financial depression, mental  depression, economic financial  depression,  financial bailouts, the largest bank failure ( Washington Mutual ) in history and  job losses. Meanwhile millions of Americans are faced with  government tax foreclosure sales. It is very important for you to seperate the financial depression from the emotional depression. I would encourage everyone to take the below 12 question self-test, view the results and recommendation:

                          Click here to take the Depression Self-Test

Don't be ashamed to seek professional help. Without stable mental health, you will not be able to cope with the stress and anxiety of the current depressed economic environment. Here is some sound advice from Scott of the Powerline blog tiltled Depession Monopoly:

Lawrence B. Lindsey, ( Director of the National Economic Council  from 2001-2002), and the Assistant to the President on Economic Policy for the U.S. President George W. Bush. Lindsey played a leading role in formulating President Bush's $1.35 trillion tax cut plan, convincing candidate Bush that he needed an "insurance policy" against an economic turndown. He left the White House in December 2002 and was replaced by Stephen Friedman after he estimated the cost of the Iraq war could reach $200 billion.

In "High Anxiety" , Lawrence Lindsey invokes the original Depresson-era Monopoly rules to explain the current economic environment. Along the way Lindsey inserts "a digression into economic self-preservation in a game of real-life Depression Monopoly" with advice that should come in handy:

"First, readers would be well advised to actually sit down and write up a budget if they have any doubts about whether their current income is covering their bills. Just to be clear, expenses include not only the minimum payment on an item like a credit card, but all the charges incurred in the month plus the minimum payment. And income does not include any draws on saving or home equity lines of credit. I once went through a budget exercise with a struggling 20-something and asked why he didn't have anything budgeted for gasoline for his car. His response was that he simply put it on his credit card so it didn't count as long as he was making the minimum payment.

Second, people should make sure that they have at least three, and ideally six, months' income saved in a place where they can get at it readily like a bank account or money-market fund. This is on top of items like retirement saving and college accounts.

Third, once this threshold is met, it is doubtless a good idea to start reducing debt, particularly on credit cards and auto loans. These are about to get much harder to obtain as the credit crunch inevitably spreads from the commanding heights of the financial sector into the consumer credit arena. It will not be surprising to see the limits on credit cards lowered sharply, fees for holding cards rise, and auto loans tough to qualify for. The goal for households should be to be able to use credit cards for convenience only--paying the bill in full each month--and to have the ability to pay cash for larger purchases like a car.

Finally, for those lucky enough to meet the above criteria, where one deploys one's assets becomes a serious matter in the current environment. There was a saying in the 1930s that you should not have all your eggs in one basket. It meant spread the assets around. In the calm environment of the last few decades this dictum was rejected for the convenience of one-stop financial shopping.

You might want to consult a financial adviser or at least inquire at the institutions where you have assets what the insurance limits are and under what circumstances your assets can be seized by creditors of the institution. This means asking questions about deposit-insurance limits, the assets backed by money-market funds, and whether your investments are in custodial accounts."

COMMENT: Scott, thanks very much for your thoughtful and timely post.

Click here to take a Depression Self Test

September 15, 2008

Depression, the great financial depression of 2008, emotional depression and the stock market crash of September 2008

There are 18 milllion Americans that  suffer from depression. Today the 27,000  employees of the now bankrupt firm of Lehman Brothers must be severely severely depressed. And the average American who owns stock is not very happy today.

The Dow Jones industrial average lost more than 500 points, more than 4 percent, its steepest point drop since the day the stock market reopened after the Sept. 11, 2001, attacks. About $700 billion evaporated from retirement plans, government pension funds and other investment portfolios.

                             

The carnage capped a tumultuous 24 hours that redrew U.S. finance. Lehman Brothers, an investment bank that predates the Civil War and weathered the Great Depression, filed the largest bankruptcy in American history. A second storied bank, Merrill Lynch, fled into the arms of Bank of America.

It was by far the most stomach-churning single day since a financial crisis began to bubble up from billions of dollars in rotten mortgage loans that have crippled the balance sheets of one bank after another and landed mortgage giants Fannie Mae and Freddie Mac under the control of the federal government.

"We are in the middle of a deep, dark recession, and it won't end soon. Here it is, and it is pretty nasty," said Barry Ritholtz, who writes the popular financial blog The Big Picture and is CEO of research firm FusionIQ.

And the fallout was far from over. American International Group, the world's largest insurer, was fighting for its very survival: New York Gov. David Paterson moved to allow the company to tap one of its subsidiaries for an emergency loan to stay above water.

"AIG still remains financially sound," Paterson said, even as the company's stock tumbled almost 60 percent. Almost $20 billion in AIG's shareholder value was wiped out Monday.

In Washington, Treasury Secretary Henry Paulson, who refused to toss a financial lifeline to Lehman, was unapologetic as the Bush administration signaled strongly that Wall Street shouldn't expect more rescues from Washington. The American people should remain confident in the "soundness and resilience in the American financial system," Paulson told reporters at the White House.

Six months ago, Paulson moved to prevent the collapse of Bear Stearns, brokering a deal for JP Morgan Chase & Co. to buy the firm at a fire-sale price with Federal Reserve backing. Earlier this month, he stepped in to help the government seize Fannie and Freddie in hopes of reversing the housing and credit crises.

But Monday, Paulson said he "never once" considered it appropriate to put taxpayer money at risk to resolve the problems at Lehman Brothers, which was saddled with $60 billion worth of soured real estate holdings. The result was one of the most momentous days in Wall Street history since legendary banker J. Pierpont Morgan helped broker the rescue of financial markets during the Panic of 1907.

Click here to take a Depression Self Test

Lehman Brothers bankruptcy, stock market crash, its effect on stress and depression.

Today Lehman Brothers filed for bankruptcy putting its 27,000 employees out of work, wiping out billions in personal net worth and the stock market erased over  $600 billion in value.

U.S. stocks tumbled, pushing the Standard & Poor's 500 Index to the steepest drop since the September 2001 terrorist attacks, as Lehman Brothers Holdings Inc.'s bankruptcy and declining commodities increased speculation that credit-market losses and the economic slowdown will worsen.

This enormous type of financial loss cannot only trigger a major depressive episode but severely aggravate existing depression in patients. Don't be ashamed to seek help from mental health professionals, friends and family.

What is the relationship between financial stress and depression? You are probably aware that when you become stressed-out, you also tend to become more depressed. There is much psychological research that confirms that there is a relationship between stress and depression. The relationship is not a simple one, however.

Keep in mind that experiencing depression symptoms is not necessarily the same as experiencing clinical depression. The depression symptoms are only considered clinical depression when they last and are severe enough that they interfere with your ability to function in some important area of your life. Depression as an illness (clinical depression) seems to have a life of it's own. It usually starts because of a stressful situation( such as a financial loss), but then it continues independent of the stressful situation

Many of you may be at risk for post-traumatic stress syndrome.

Posttraumatic stress disorder (PTSD) is an emotional illness that develops as a result of a terribly frightening, life-threatening, or otherwise highly unsafe experience. PTSD sufferers re-experience the traumatic event or events in some way, tend to avoid places, people, or other things that remind them of the event (avoidance), and are exquisitely sensitive to normal life experiences (hyperarousal). Although this condition has likely existed since human beings have endured trauma, PTSD has only been recognized as a formal diagnosis since 1980

Getting laid off affects not only one's economic well-being, it also curtails one's involvement in community and social activities, a new study found. Displaced workers are most likely to withdraw from participating in youth and community groups, followed by church and church groups, charitable organizations and leisurely activities, such as country club attendance.

Seek professional advice to help bridge the gap you are suffering during this once-in-a life-time traumatic event.

 

Click here to take a Depression Self Test

David Foster Wallace, author of "Infinite Jest", commits suicide by hanging himself at his home.

This is a very sad  story of great success with a very tragic ending. David Foster Wallace, the brilliant author of Infinite Jest committed suicide at his home yesterday:

In 1987 after David Foster Wallace became a twentysomething literary phenom—following  the publication of his first novel ("The Broom of the System," 1987) and short-story collection ("Girl With Curious Hair," 1989) got the Thomas Pynchon comparisons flowing—he checked himself into a hospital and asked to be put on suicide watch.

"In a weird way it seemed like there was something very American about what was going on, that things were getting better and better for me in terms of all the stuff I thought I wanted, and I was getting unhappier and unhappier," he told me in 1996 upon the publication of "Infinite Jest," the 1,000-plus-page novel that would cement his status as one the few modern-day literary giants.

At the time, Wallace, who grew up in Urbana, was teaching English literature and creative writing at Illinois State University in Normal, and he strove to maintain a sense of normality even as reviewers such as New York magazine's Walter Kirn were raving about "Infinite Jest": "It's as though Paul Bunyan had joined the NFL or Wittgenstein had gone on 'Jeopardy!' The novel is that colossally disruptive. And that spectacularly good."

By many accounts, he succeeded; his former students and colleagues remember him as a deeply caring person whose casual persona as the bandanna-wearing "Dave" was far removed from his lofty literary reputation

So the news that the 46-year-old writer was found dead by his wife Friday night after apparently hanging himself in his California home sparked equal parts shock, sadness and an aching sense of loss among those who knew him and his writings.

"He had a mind that seemed to see everything on every level all at once," said Michael Pietsch, publisher of Little, Brown, longtime home to Wallace's works. "Beside the talent that left every other writer I knew in awe of him, he was just so gentle and tried not to be intimidating, a man who went out of his way to be fair, to be understanding to be kind.

"I feel every word I speak is a ridiculous reduction of a mind and a talent that no one could begin to grasp."

Wallace, who received a MacArthur Foundation "genius grant" in 1997, had moved from Illinois State to Pomona College's English Department in 2002 to take a tenured position endowed by Roy E. Disney. Although he didn't publish another novel after "Infinite Jest," he remained a prolific writer of essays (many, myself included, think the title piece of the 1998 collection "A Supposedly Fun Thing I'll Never Do Again," an account of a hellish vacation cruise, is one of the funniest-ever pieces of magazine journalism) and short stories ("Oblivion," his latest collection, came out in 2004).

In June, Little, Brown reissued Wallace's account of John McCain's 2000 presidential campaign as the paperback "McCain's Promise: Aboard the Straight Talk Express With John McCain and a Whole Bunch of Actual Reporters, Thinking About Hope."

Wallace wrote with an oversize personality but avoided celebrity. His writing was intellectual and emotional, hilarious and dazzling. He used big words, and made an art form of footnotes and endnotes.

He also was prescient: "Infinite Jest" envisioned people pleasuring themselves to death through entertainment in a world in which everything, even years, had corporate sponsors. Yet as lively and satirical as that book was, he told me his primary goal was "to do a book that was sad."

Said Pietsch: "The experiences of pain in that book are many, but at the same time it's a celebration of every one of them for their spirit and their resilience."

Like many brilliant minds, Wallace nonetheless struggled to find meaning in existence, light against the darkness. It's no wonder that this passage from his 2005 commencement speech at Kenyon College is now making the Internet rounds:

"Learning how to think really means learning how to exercise some control over how and what you think. It means being conscious and aware enough to choose what you pay attention to and to choose how you construct meaning from experience. Because if you cannot exercise this kind of choice in adult life, you will be totally hosed. Think of the old cliché about, quote, the mind being an excellent servant but a terrible master.

"This, like many clichés, so lame and unexciting on the surface, actually expresses a great and terrible truth. It is not the least bit coincidental that adults who commit suicide with firearms almost always shoot themselves in: the head. They shoot the terrible master. And the truth is that most of these suicides are actually dead long before they pull the trigger."

COMMENT: Mr Wallace seemed to have eveything; fame,  fortune. friends and fans. Yet he had nothing without inner happiness. May he rest in peace

Click here to take a Depression Self Test

September 13, 2008

Barbara Walter's view about Elisabeth Hasselbeck and her grandiose behavior: are her days on "The View" numbered?

The inappropriate, manic and grandiose behavior of some celebreties never ceases to amaze me. They never think about the consequences of their irratic behavior. Star Jones destroyed her career on ABC's The View. Now Elisabeth Hasselbeck is in trouble.

Barbara Walters has had it with Elisabeth Hasselbeck, dishes Celebitchy. The 'View' queen bee cut off her conservative co-host during a particularly heated political debate and said if she couldn't calm down, she should find a new job. Let's hear it for no self-control! (Sept. 12)

Apparently Elisabeth Hasselbeck is pissing off Barbara Walters, the 78 year-old co-creator and co-producer. Elisabeth got upset in a discussion on air about VP Republican candidate Sarah Palin and Walters had to tell her to “calm down” and the show went to a commercial. Off air, The National Enquirer reports that Walters scolded 31 year-old Elisabeth and told her that if she can’t be measured in her opinions she should get a new job:

Elisabeth… got snippy [with her “View co-hosts] during a heated discussion of Republican vice presidential candidate Sarah Palin on the show’s September 2 season premiere. Sensing the debate was spinning out of control, Barbara ordered Elisabeth, an ardent Republican, to “calm down,” and the show immediately cut to a commercial.

.“During the break, Barbara lashed out at Elisabeth,” an insider revealed. “In her typical style, she maintained her composure so it appeared everything was OK, but she made it clear to Elisabeth that she needed to calm down…”

When the taping was over, the… TV veteran had more to say to Elisabeth, according to the source.

“Barbara told Elisabeth that everyone welcomes her opinions, but demanded that she find an appropriate way to express them, and she said that if Elisabeth can’t do that, then maybe she should consider a new line of work,” said the insider.

COMMENT: Clearly Elisabeth has some sort of mood disorder. If Ms. Hasselbeck doesn't settle down, her new View may be her bedroom.

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Click here to take a Depression Self Test

September 09, 2008

Deep brain stimulation may be the next frontier in new depression treatments: "where no man has gone before....."

Vagus nerve stimulation therapy  has been nicknamed the pacemaker for the brain. It is a 90-minute same day  procedure that involves the insertion of a "pacemaker-like" device in the patient's upper left chest. It is an FDA approved procedure for major depression.

A new and exciting investigational ( i.e. non FDA-approved) therapy has also been nicknamed pacemaker for the brain. It is called deep brain stimulation and  is currently used with Parkinson's patients.  Scientists  growing understanding of the electrical architecture of the brain—a vast, complex network of circuits that record and relay information has let to this technique that offers new hope to people with treatment-resistant depression.

Deep brain stimulation employs electricity to jolt the brain in pinpointed locations. According to Dr. Ali Rezai, director of the Cleveland Clinic's Center for Neurological Restoration, "I believe this field is where heart pacemaker devices were 25 to 30 years ago. Brain pacemakers are going to have a significant impact on the treatment for a number of neurological and behavioral conditions,"

But the buzz surrounding the procedure is a sign that science's growing knowledge of the brain's circuitry is generating exciting avenues for medical treatments. Doctors who now have to fight stubborn diseases primarily by dosing the brain with chemicals have hope of intervening more directly and precisely.

Guiding researchers' efforts are new brain maps generated by sophisticated imaging technologies such as functional MRIs and PET scans. By recording activity in both sick and healthy people, scientists are learning how brain circuits work and discovering where significant breakdowns seem to occur.

Those locations become possible targets for deep brain stimulation, or the application of a constant current of electricity to a specific location in the brain. The current tamps down circuits that are firing abnormally or revs up circuits that are underactive, experts theorize.

The technique involves drilling two dime-size holes in a person's skull and carefully guiding electrodes to a spot about the size of a Tic Tac or a small olive. Then, electrodes are connected with leads that snake down under the skin of the neck to a battery-operated device implanted under the collarbone.

Insertion of electrode during surgery

The Science, however, is still at a very preliminary stage. In more than a dozen interviews, scientists said they were still uncertain which patients are most likely to benefit from the procedures, whether relief of symptoms will be long-lasting and what the long-term side effects are likely to be.

Given the risks, deep brain stimulation should be a "last resort for stringently selected patients" who have failed all other therapies, said Dr. Wayne Goodman of the National Institute of Mental Health.

Still, some of the early results are remarkable.

"By seeing severe depression as a circuit disease, we have developed a new platform for treatment that can give people hope," said Dr. Helen Mayberg, a co-author of the new paper and a professor of psychiatry and neurology at Emory University in Atlanta.

COMMENT: We need every weapon possible to battle this baffling disease. Dr. Helen Mayberg is a brilliant neuropsychiatrist to lead the charge for the potential new medical breakthrough.

Click here to take a Depression Self Test

September 07, 2008

Barbara Walters must be furious! The View's Elisabeth Hasselbeck manic behavior at a tribute to Cindy McCain. I think she should be fired.

On Thursday,  Elisabeth Hasselbeck of ABC's The View flew to Minneapolis to emcee a luncheon in a tribute to Cindy McCain. The View previously had hosted both Michelle Obama, the wife of Democratic Presidential candidate Barack Obama and Cindy McCain wife of Republican Presidential Candidate John McCain.

I was shocked at not only what Ms. Hasselbeck said at the podium, but also the snotty tone. This is what she said:

“Unlike the wife of another political candidate( i.e. Michelle Obama) who shall remain nameless, Cindy McCain didn’t come [to cohost The View] with a list of topics we weren’t allowed to touch.”

I was outraged when I saw the video. Ms. Hasselback's tone was arrogant, self-righteous and condescending. Utlimately she not only made herself look bad but also the honoree. Cindy McCain must have been very embarrassed by that type unprofessional behavior, the catty comments as well as the deliberate dig at Michelle Obama.

Why didn't the  hard-hitting Hasselbeck use Cindy McCain's View stint to grill her on the Keating Five scandal, Cindy's history of drug addiction, and the illegally written prescriptions ( a felony) she used to procure those drugs. Hasselbeck never asked about any of those things, and I am positive that Cindy never expected her to.

BARBARA WALTERS MUST REALLY BE PISSED!

Barbara Walters must really be pissed. Ms. Hasselbeck violated not only Michelle Obama's privacy, but also the privacy of every future guest on The View. ABC and Barbara Walters should fire Ms. Hasselbeck on Monday morning. And Ms. Hasselbeck should fully publicize all aspects of her firing, because she has "nothing to hide".

Hasselbeck's behavior had all the classic symptoms of someone who is manic:

  1. inflated self-esteem or grandiosity
  2. flight of ideas
  3. increase in goal directed activity ( i.e. politics)
  4. engaging in inappropriate behavior without thinking about the consequences

COMMENT: I will let you make the call.

Click here to take a Depression Self Test

September 04, 2008

Chronic back pain can be successfully treated with the antidepressant Cymbalta.

Depression not only causes emotional pain, but also physical pain. Sometimes the physical pain manifests itself in the form of chronic back pain. Ironically a new clinical study showed that the antidepressant Cymbalta brought pain relief to sufferers of back pain.

The drug Cymbalta is commonly used to treat depression, anxiety disorders, diabetic nerve pain and fibromyalgia but in a study by the manufacturer Eli Lilly it was also found to significantly reduce back pain in comparison with a placebo( a sugar pill).This new study involved 236 adults with chronic low back pain who were not suffering from depression.

I thought that this study was fascinating. The idea that a drug could bring both pain relief while also relieving depression symptoms could be wonderful. In this particular  13 week study, patients were given a daily dose of either Cymbalta or a placebo and the researchers found that 31% of patients receiving the drug experienced a 50% reduction in pain, compared with 19% of individuals in the placebo group.

Weekly pain scores, measured before taking Cymbalta or the placebo and again at the end of the study, showed greater improvement in the Cymbalta group. The study was presented in Madrid at the 12th Congress of the European Federation of the Neurological Sciences from August 23rd-August 28th, 2008.

COMMENT: I would nickname this drug "buy one and get one free."

Click here to take a Depression Self Test

How does the new diet treatment of vagal bloc for obesity control or VBLOC may help you lose weight.

Many depression patients also suffer from obesity and are at higher risk of developing Type II diabetes. There is a new investigational  treatment for obesity called VBLOC or vagal block for obesity control.  It is a pacemaker-like device that potentially may help obese Americans drop pounds.The obesity problem in America has led to countless new weight loss strategies from low-calorie diets to drastic surgery; but now a new device falls somewhere in the middle.

(Above picture) Course and distribution of the glossopharyngeal, vagus, and accessory nerves.

The  experimental weight loss device works by slowing down digestion. Doctors first implant a device about the size of a pacemaker inside the abdomen. It sends electrical signals to block the vagus nerve, which normally helps the stomach expand to take in a meal and contract to digest it. According to Dr. James Maher, a surgeon at Virginia Commonwealth University

"If we're right about what the vagus nerves do, then if you can't accommodate a large meal, you get full more quickly," "If your stomach's not emptying as quickly, you don't get hungry again as quickly."

Patients wear a belt with a coil over the implanted device to turn it on. "When they take the coil off at night," Maher adds, "they're no longer treating themselves and so the nerve completely recovers during that period of time."

Doctors first implant a device about the size of a pacemaker inside the abdomen. It sends electrical signals to block the vagus nerve, which normally helps the stomach expand to take in a meal and contract to digest it.

                             Vbloc

"If we're right about what the vagus nerves do, then if you can't accommodate a large meal, you get full more quickly," Dr. Maher explains. "If your stomach's not emptying as quickly, you don't get hungry again as quickly."

Patients wear a belt with a coil over the implanted device to turn it on. "When they take the coil off at night," Maher adds, "they're no longer treating themselves and so the nerve completely recovers during that period of time."

If approved by the FDA this would be a major medical breakthrough for millions of obese Americans. I will have more posts about this very important topic.

Click here to take a Depression Self Test

September 03, 2008

New diet treatment: Vagal blocking for obesity control (VBLOC)- clinical study enrollment completed.

I thought this would be an interesting post for two reasons: 1) information about VBLOC and 2) insight in to how an FDA study is designed. Obviously if the study reaches its primary outcomes, it will have enormous ramifications for obese Americans trying to lose weight as well as for a Type II diabetes patients.

This is a long a complicated post. Please remember that enrollment is complete. No further patients will be included.

All  patients in the double-blind, placebo-controlled clinical trial to study vagal bloc for obesity control( VBLOC) have been enrolled and the one year study is in full gear. The study Sponsor is EnteroMedics.

According to the Sponsor:

Official Study Name: EMPOWER Clinical Trial: Vagal Blocking for Obesity Control

Study Type: interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measures:

  • To demonstrate a significantly greater percentage of excess weight loss with the Maestro System which provides VBLOC therapy. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • To estimate the rate of serious, system- and procedure-related adverse events associated with the Maestro System. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
  •           Secondary Outcome Measures:

    • To demonstrate a significant difference between treatment groups in the proportion of subjects realizing at least a 25% excess weight loss from implant. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

    Vbloc_2

    This is a randomized multi-center study being done to measure the ability of a new medical device, Maestro System, to safely reduce body weight over five years in people who are considered obese.


    Condition Intervention
    Obesity Device: Active, implantable, intra-abdominal vagal blocking medical device

    Related topics:    Obesity    Weight Control   

    U.S. FDA Resources


    Arms Assigned Interventions
    A: Experimental
    Subjects will be implanted with the Maestro System and are randomized to having VBLOC therapy ON.
    Device: Active, implantable, intra-abdominal vagal blocking medical device
    Intermittent, programmable, intra-abdominal vagal blocking
    B: Placebo Comparator
    Subjects will be implanted with the Maestro System and are randomized to having VBLOC therapy OFF.
    Device: Active, implantable, intra-abdominal vagal blocking medical device
    Intermittent, programmable, intra-abdominal vagal blocking

    Detailed Description:

    The Maestro System is a neuromodulation system that consists of implantable and external components.

    Implantable components: two leads (one electrode each for the anterior and posterior intra-abdominal vagal nerve trunks) that are connected to an implantable neuroregulator.

    External components: one programmable, battery-powered, ambulatory external controller connected via a small, flexible cable to a cutaneous transmit coil that is positioned over the neuroregulator. A clinician programmer that transmits information to the controller and uploads data from the controller.

    All non-diabetic subjects will be randomized in a 2:1 allocation to therapy ON or therapy OFF groups. All type 2 diabetes mellitus subjects will be randomized in a 1:1 allocation to therapy ON or therapy OFF groups.

    All subjects will receive blinded therapy through the 12-month follow-up visit. All subjects will participate in a medical weight management program.

    Ages Eligible for Study:    18 Years to 65 Years
    Genders Eligible for Study:    Both
    Accepts Healthy Volunteers:    No

    Criteria

    Inclusion Criteria:

    • Informed consent.
    • Body mass index (BMI) ≥ 40 kg/m2 to 45 kg/m2 or BMI ≥ 35 kg/m2 to 39.9 kg/m2 with one or more severe obesity related co-morbid condition.
    • Females or males
    • 18-65 years of age inclusive.
    • Type 2 diabetes mellitus subjects that are well-controlled (at selected centers, limited to approximately 26 subjects).
    • Failure to respond to supervised diet/exercise program(s) in which the subject was engaged for at least 6 months.
    • Ability to complete all study visits and procedures.

    Exclusion Criteria:

    • Concurrent chronic pancreatic disease.
    • History of Crohn's disease and/or ulcerative colitis.
    • History of bariatric surgery, fundoplication, gastric resection or major upper-abdominal surgery.
    • History of pulmonary embolism or blood coagulation disorders.
    • Clinically significant hiatal hernias known from subject's medical record as or determined by upper endoscopy prior to implant.
    • Current portal hypertension and/or esophageal varices.
    • Intra-operative exclusion: hiatal hernia requiring surgical repair or extensive dissection at esophagogastric junction at time of surgery.
    • Treatment with weight-loss prescription drug therapy within the prior three months and the use of prescription drug therapy or the use over-the-counter weight loss preparations for the duration of the trial.
    • Smoking cessation within the prior six months.
    • Known genetic cause of obesity.
    • Overall sustained reduction of more than 10% of body weight in the previous 12 months.
    • Pre-operative diet with intent to lose weight prior to surgery.
    Click here for more information about the EMPOWER Clinical Trial: Vagal Blocking for Obesity Control   
     

     
     
     
    ClinicalTrials.gov Identifier:    NCT00521079
    Health Authority:    United States Food and Drug Administration

    Links to all studies - primarily for crawlers

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