Could Social Anxiety Be Treated With BOTOX?

George Washington University in Washington, DC, is currently recruiting volunteers for a new study testing Botox to help symptoms of social anxiety.  

To see if you qualify for the free study, go to GWUanxiety.com

Social anxiety disorder (SAD), also known as social phobia, is a psychiatric condition affecting 12% of adults, approximately 20 million Americans, according to the National Comorbidity Survey Replication (NCS-R) (1) and noted by the National Institutes of Mental Health. SAD typically begins in the teenage years. The anxiety disorder is characterized by a high level of fear in social situations causing emotional distress and isolation, affecting work, community and romantic relationships. The George Washington University is currently recruiting volunteers for a new study testing the ability of botulinum toxin A, commonly known as Botox, to help symptoms of social anxiety. To see if one qualifies for this free study taking place at GWU in Washington, DC, go to www.GWUanxiety.com.

This pioneering research is being led by Eric Finzi, MD, PhD, the first to publish a study using Botox to treat depression (2), and Daniel Lieberman, MD, Professor of Psychiatry and Behavioral Sciences at The George Washington University School of Medicine & Health Sciences. This study is testing whether Botox injected into the frown muscles (the muscles that pull the eyebrows together to produce a worried look) will help with social anxiety as it does with depression.

“The same part of the brain involved in depression, the amygdala, is also involved in SAD (3,4),” explains Dr. Eric Finzi. “It is my hope this common and debilitating disorder, social anxiety, will be helped by Botox treatment,” he adds.

Dr. Lieberman notes, “Although Botox is used primarily for cosmetic purposes, its effect on anxiety and depression have nothing to do with changes in appearance. It seems that paralyzing the frown muscles actually quiets down a part of the brain that amplifies negative emotions (5).” Social anxiety is a debilitating illness that often goes untreated. It is common for some sufferers to self-medicate with alcohol or other drugs to reduce fears at social events. If undiagnosed or untreated, social anxiety can lead to alcoholism, eating disorders or other kinds of substance abuse.

One of the more effective ways to treat social anxiety is with cognitive behavioral therapy (CBT). However, it is time consuming and it can be difficult to find a therapist with the proper training. Physicians often prescribe antidepressants, but more than half fail to respond adequately (6). In addition, antidepressant’s side effects may cause other unwanted health issues for users. Botox has a very favorable side effect profile, and has been in use for more than twenty years.

In 2014, Eric Finzi, MD, PhD and psychiatrist Norman E. Rosenthal, MD, Clinical Professor of Psychiatry at Georgetown Medical School, published the largest randomized, double-blind, placebo controlled trial on the effect of Botox on depression (7). They found that more than half of subjects suffering from moderate to severe depression showed a substantial improvement (greater than or equal to a 50% reduction in depressive symptoms) as measured by the MADRS, a standard depression scale. The study showed that Botox may help relieve depression both by itself as well when it is added to boost other treatments. There have been two other randomized controlled trials showing the effectiveness of Botox to treat depression, with similar results (8). Clinical trials are currently underway to get FDA approval for this novel treatment.

Persons interested in more information and to see if they qualify as a volunteer for this experimental treatment of social anxiety, can go to www.GWUanxiey.com. For more information about Botox to treat depression, go to www.BotoxForDepression.com.

MEDIA INQUIRIES CONTACT: Michelle Delino (202) 486-7622 or by email: contact@michelledelinomedia.com

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Resources:
1. Kessler, Ronald C., et al. “Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication.” Archives of general psychiatry 62.6 (2005): 593-602.
2. Finzi, Eric, and Erika Wasserman. “Treatment of depression with botulinum toxin A: a case series.” Dermatologic Surgery 32.5 (2006): 645-650.
3. Labuschagne, Izelle, et al. “Oxytocin Attenuates Amygdala Reactivity to Fear in Generalized Social Anxiety Disorder.” Neuropsychopharmacology 35 (2010): 2403- 2413.
4. Victor, Teresa A., et al. “Relationship between amygdala responses to masked faces and mood state and treatment in major depressive disorder.” Archives of general psychiatry 67.11 (2010): 1128-1138.
5. Kim, M. Justin, et al. “Botulinum toxin-induced facial muscle paralysis affects amygdala responses to the perception of emotional expressions: preliminary findings from an ABA design.” (2014).
6. Trivedi, Madhukar H., et al. “Evaluation of outcomes with citalopram for depression using measurement-based care in STAR* D: implications for clinical practice.” American journal of Psychiatry 163.1 (2006): 28-40.
7. Finzi, Eric, and Norman E. Rosenthal. “Treatment of depression with onabotulinumtoxinA: a randomized, double-blind, placebo controlled trial.” Journal of psychiatric research 52 (2014): 1-6.
8. Magid, M., et al. “Treating depression with botulinum toxin: a pooled analysis of randomized controlled trials.” Pharmacopsychiatry 25.06 (2015): 205-210.

BuzzFeed News on Possible Treatments for Depression

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Botox, Cough Syrup, And An Anesthetic Are All Being Tested As Antidepressants

Pharma companies are looking at old drugs — including a common cough suppressant, an opiate addiction treatment, and even Botox — for new ways to treat depression.

Despite the dozens of prescription drugs on the market for treating depression, up to half of depressed people can’t find relief.

That’s an enormous market opportunity: millions of people who need daily treatment for a chronic condition. But after years of expensive failures trying to develop new antidepressants from scratch, many companies have largely lost interest. Read More

 

New Botox for Depression Research Published in Pharmacopsychiatry

Treating Depression with Botulinum Toxin: A Pooled Analysis of Randomized Controlled Trials

Abstract

Introduction: Botulinum toxin A (BTA) injection into the glabellar region is currently being studied as a treatment for major depressive disorder (MDD). Here we explore efficacy data of this novel approach in a pooled analysis.

Methods: A literature search revealed 3 RCTs on this topic. Individual patient data and clinical end points shared by these 3 trials were pooled and analyzed as one study (n=134) using multiple regression models with random effects.

Results: In the pooled sample, the BTA (n=59) and the placebo group (n=75) did not differ in the baseline variables. Efficacy outcomes revealed BTA superiority over placebo: Improvement in the Hamilton Depression Rating Scale or Montgomery-Asberg Depression Rating Scale 6 weeks after baseline was 45.7% for BTA vs. 14.6% for placebo (p<0.0001), corresponding to a BTA response rate of 54.2% (vs. 10.7%) and a BTA remission rate of 30.5% (vs. 6.7%).

Discussion: Equalling the status of a meta-analysis, this study increases evidence that a single treatment of BTA into the glabellar region can reduce symptoms of MDD. Further studies are needed to better understand how BTA exerts its mood-lifting effect.  Read More…

 

 

Forbes Magazine “Botox Seems To Ease Depression”

Forbes.com’s Matthew Herper, a reporter on the Pharma and Healthcare beat, covered the recent annual meeting of the American Psychiatric Association in Toronto and wrote about the collective data findings on Botox to treat depression. Herper writes, “the analysis of the data published so far presented here at the American Psychiatric Association in Toronto seem to support the idea that Botox injections in the face can ease depressed mood.” Read more.

LISTEN LIVE WNPR Radio Today 12/11 at 1:00PM

Colin McEnroe ShowDr. Eric Finzi will be a guest on NPR Boston’s The Colin McEnroe Radio Show today at approximately 1:06PM EST talking about the Botox for Depression research study findings published in the Journal of Psychiatric Research (May 2014). The study “Treatment of Depression with onabotulinumtoxinA: A Randomized Double-Blind, Placebo Controlled Trial” found that 52% of subjects suffering from moderate to severe depression showed a relief from depression after injection of botulinum toxin to the glabellar area between the eyes, compared with only 15% of those who received the saline placebo. A second phase to this study is in the works.

This year marks commemorates the 25th anniversary of the first approved uses of BOTOX® and to honor its heritage as a medical advancement. You can listen to the program LIVE at http://wnpr.org/programs/colin-mcenroe-show and click on “stream us live” link.

The following information is published on Allergan, the makers of Botox’s  website:

While BOTOX® Cosmetic (onabotulinumtoxinA) has become a household name, BOTOX® was the first botulinum toxin type A treatment to be approved by the U.S. Food and Drug Administration as an orphan drug for two rare, eye muscle disorders.  This journey, which started in 1989, began with the approval of BOTOX® to treat strabismus (a misalignment of the eyes, commonly known as crossed eyes) and blepharospasm (uncontrolled blinking of the eyelid).  Strabismus affects nearly four in every 100 adults,1 and blepharospasm affects an estimated 20,000 to 50,000 people in the United States, with 2,000 new cases diagnosed annually.2 Since that time, BOTOX® therapeutic has been approved for other significant medical conditions including Cervical Dystonia, Severe Underarm Sweating when topical agents don’t work sufficiently, Upper Limb Spasticity, Chronic Migraine, Overactive Bladder when an anticholinergic doesn’t work or the side effects are intolerable, and urinary incontinence due to overactive bladder caused by a neurologic condition when an anticholinergic doesn’t work or the side effects are intolerable.

“BOTOX® is an innovative product whose potential to treat medical conditions across a variety of therapeutic categories continues to expand even today,” said David E.I. Pyott, Chairman of the Board and Chief Executive Officer, Allergan.  “The more we research the medical value of this treatment, the more we learn about this biologic and the areas of clinical unmet need where it may provide some benefit.  Since BOTOX® was first approved 25 years ago, the list of indications it treats has grown exponentially – not just in the United States, but globally.  Today, physicians in 88 countries treat 27 different conditions with BOTOX® and the possibilities continue to grow with Allergan’s research.”3

The video, which outlines the 25-year history of development for BOTOX® therapeutic, features first-hand accounts from patients who chronicle their journey from diagnosis to treatment, as well as physicians who share their personal experiences in advancing the development of this brand, showcasing its therapeutic roots.

For each person that views the video, Allergan will support four patient advocacy organizations that are partnering with the company to help raise awareness, educate and support people living with any of the medical conditions currently being treated with BOTOX®.  Support will be given to:

  • Benign Essential Blepharospasm Research Foundation (BEBRF)
  • Dystonia Medical Research Foundation (DMRF)
  • National Headache Foundation (NHF)
  • National Association for Continence (NAFC)

“The history of BOTOX® therapeutic is really a remarkable story of how a substance from nature has been successfully harnessed for medical benefit,” said Scott Whitcup, M.D., Allergan’s Executive Vice President, Research and Development and Chief Scientific Officer, “It’s also a human interest story that starts with the scientists and the physicians who observed the impact of BOTOX® in treating certain medical conditions, tracked that impact and did something about it.  Without this pioneering spirit, we would not have been able to pursue the clinical development and FDA approval of many of the therapeutic indications we now have for BOTOX®.”

To learn more about BOTOX® and to view the 25th anniversary video please visitwww.BOTOX.com.

About BOTOX®(onabotulinumtoxinA)BOTOX® is a prescription-only medical product that contains tiny amounts of a highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum.  When injected at doses approved by the U.S. Food and Drug Administration (FDA) into a specific muscle or gland, BOTOX® neurotoxin is expected to produce a safe, as well as effective result, usually lasting up to approximately three to ten months, depending on the approved indication and on the individual patient.

BOTOX®was first approved in 1989 by the U.S. Food and Drug Administration (FDA) for the treatment of two eye muscle disorders, making it the first botulinum toxin type A product to be approved in the world.  Since then, BOTOX®has been recognized by regulatory authorities as an effective treatment for 27 different indications in approximately 88 countries, benefiting patients worldwide.

Today, BOTOX®neurotoxin is approved to treat a total of eight medical conditions in the United States, including:

  • the treatment of overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken;
  • the treatment of leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication;
  • the prevention of headaches in adults with chronic migraine who have 15 or more days each month with headache lasting four or more hours each day in people 18 years or older;
  • the treatment of increased muscle stiffness in elbow, wrist, and finger muscles in people 18 years and older with upper limb spasticity;
  • the treatment of the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older;
  • the treatment of certain types of eye muscle problems (strabismus) in people 12 years and older;
  • the treatment of abnormal spasm of the eyelids (blepharospasm) in people 12 years and older; and
  • the treatment of symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.

NBC Today Show

NBC News Today Show correspondent Tom Costello interviews Dr. Eric Finzi and two Botox to treat depression research study participants about the unbelievable treatment for depression.

Today Show interviews Dr. Eric Finzi 7/11/14

Today Show interviews Dr. Eric Finzi 7/11/14

VIEW VIDEO: Today Show July 11, 2014 featuring Botox to treat depression study

 

NBC Washington Features Botox for Depression Research

Dr. Eric Finzi and Sarah Bergman, a Botox for depression study patient, were interviewed by WRC-TV news anchor Barbara Harrison on Tuesday, April 1, 2014 about the latest study findings published in the Journal of Psychiatric Research in May 2014.

Dr. Eric Finzi on NBC Washington, WRC-TV mid-day with Barbara Harrison

Botox for Depression? You’ve Got to be Kidding

 I have always gravitated to research approaches that are off the beaten track, such as the study of SAD and light therapy that I spearheaded at the National Institute of Mental Health (NIMH) over 30 years ago. At that time, seasonal affective disorder (SAD) had not yet been identified: we went on to name it and describe its typical symptoms.  Light therapy, as it’s used for SAD, was unknown.  My colleagues thought I had lost it. Yet now we recognize that millions of people the world over suffer from SAD and countless people have benefited from light therapy.

Botox for Depression, Eric FinziIt was this same out-of-the-box instinct for a winner that went on alert when my colleague, Dr. Eric Finzi, a local dermatologist approached me with a novel idea for treating depression.  Some years before, after leaving the NIMH, I had opened up a private clinical research organization in the hope of doing innovative and creative studies. Although that was possible to some extent (for example, I was able to study the effects of Transcendental Meditation on bipolar disorder and post-traumatic stress disorder), the reality of the work revolved mostly around testing new drugs. So, I was always on the lookout for something really different and exciting.

Botox for Depression, Research, Dr. Eric Finzi, Dr. Norman E. Rosenthal, Charles Darwin, Faces of Emotion Dr. Finzi had read the work of Charles Darwin and the famous psychologist William James, both of whom had suggested that cues from the body, including the face, had a powerful effect on human emotions.  Darwin called the frown muscles between the eyebrows “the grief muscles,” and suggested that they were not just a reflection of sorrow, but also fueled it. An extensive subsequent literature supported this “facial feedback hypothesis,” and numerous experiments showed that facial expressions affect the way we feel.

Botox for Depression, Eric Finzi, Faces of Emotion

 Finzi has described this history in a highly readable book, The Face of Emotion.  Now Finzi had an idea as to how these insights could be used to treat depression – by means of botulinum toxin (Botox), which is known to paralyze muscles.  How would it be, he wondered, if we paralyzed the frown muscles between the eyebrows in a double-blind study with saline as a control? An encouraging pilot study suggested it might work.  But this would now need to be tested in a controlled study. Would I be interested in conducting such a study in my research organization?  Well, I loved the idea! And that was the beginning of an enjoyable collaboration. 

Emotion Revolution, Dr. Norman Rosenthal Another reason why Finzi’s idea appealed to me so much is that over a decade before he approached me, I had written a book about the science of emotion, called The Emotional Revolution.  In it I wrote:

Among the sensory nerves that influence our mood are those that pass directly through the skull and into the brain.  These are known as the cranial nerves.  Exposure to light stimulates one pair of these nerves, the optic nerves. Another pair, the olfactory nerves, transmits sensations of smell to the brain.  The fragrance of lemons lifts the mood of depressed patients with SAD.

FrownIt was highly plausible to me that frowning might send signals to the brain via different cranial nerves – the facial and trigeminal nerves.  But in this case, it seemed, the signals aggravated a person’s mood rather than relieving it.  So it made all the sense in the world to me that blocking these signals might reverse depression. 

So Finzi and I embarked on a controlled study of Botox for depression in collaboration with a great team of psychiatrists and administrators at my research organization.  We entered 74 depressed people into a double blind, placebo controlled study and when we finally analyzed the data, the results were clear and strong. Botox beat placebo, significantly reducing depression levels, regardless of whether patients were already on antidepressants (to which they had not responded) or were untreated.

The results of the study are due to appear in the Journal of Psychiatric Research in May 2014, but the abstract is already available online.  READ THE ABSTRACT

Botox for Depression, Research, Dr. Eric Finzi, Dr. Norman E. Rosenthal, Botox, Depression As a psychiatrist who has treated many people with depression, I am truly excited at this new treatment option. Although there are many available treatments for this very painful affliction, they are often only partially effective and have troublesome side-effects.  I am delighted that we now have a new treatment option which can be used safely alongside all other treatments (as the Botox acts only locally in the muscles and is not absorbed).  In addition, when properly administered by a trained person, Botox has few if any side-effects.  So, what’s the catch?

Well, first of all, as with any treatment for depression, some people don’t respond; second, it is expensive – an average treatment costs about $400; and finally, the effects of Botox wear off after about 2 to 3 months, so treatments may need to be repeated.  I hope that, with replication of our findings and wider use, insurance coverage may become available.  In the meanwhile, for someone suffering from the agonizing pangs of depression, the benefit of Botox may be well worth the cost.

For an additional perspective check out the following link to a New York Times Op Ed piece by Dr. Richard Friedman on the subject – Don’t Worry, Get Botox.

Wishing you Light & Transcendence,

Norman

 

 

Botox for Depression: From Darwin to Botox

Botox for Depression, Eric Finzi, Norman Rosenthatll

Botox for Depression, Eric Finzi, Norman Rosenthatll

This journey started when I was a little boy, seeing my mother’s pain, and led unexpectedly to using botulinum toxin to treat depression. Sounds pretty far –fetched, but then many scientific discoveries are only logical in hindsight. I will never forget the etched and furrowed brow of my depressed mother – her suffering became a memory that inspired me to try and figure out what role our facial expressions play in our mental health.

Botox for Depression, Eric Finzi, Norman Rosenthatll

Augustine, Attitudes Passionelle, resin on wood, Finzi 2003

Serendipity drew me into the facial expression field- I am an artist and was intrigued by a riveting series of photographs of hysteric and depressed patients from the 19th century in the Parisenne hospital Salpetriere. I began working on paintings based on these women. To try and understand their world better I read authors from their time.Botox for Depression, Charles Darwin, Eric Finzi, Norman Rosenthall 
Freud led to Darwin’s gem of a book, The Expression of Emotions in Man and Animals from 1872. Wow! Reading this wonderful but relatively unknown work of Darwin’s opened my eyes to a new way of viewing emotion. Darwin and William James, the American psychologist, both recognized that the bodily expression of our emotions really is the emotion, and that our facial expressions are a central driving force of our emotions. Botox for Depression, Charles Darwin, Expression of the Emotions in Man and Amimals, Eric Finzi, Norman Rosenthal, Botox, Depression

I found 40 years of research demonstrating that facial feedback to our brains really occurs. The more I read, the more I was convinced of the importance of facial expressions for our emotions and our mental health. Our emotions are embodied by our faces, embodied by the muscles that help move our lips, our eyes, our eyebrows. You need your smile to help you “feel” the emotion. Conversely, frowning will negatively affect your thinking, coloring your view of the world around you. But I realized that very few people were aware of this line of reasoning, or of why Botox could possibly help ones mood.

Botox for Depression, Eric Finzi, Norman Rosenthatll More than ten years ago I hypothesized that Botox could help control the flow of negative emotions by quieting the facial muscles that really express negativity, the muscles between the eyebrows that help create the frown. In 2003, I began a clinical trial to test my hypothesis that Botox inhibition of the frown muscle could help depressed patients. My 2006 study, Treatment of Depression with Botulinum Toxin A: A Case Study showed that nine of the ten patients were no longer clinically depressed after Botox injections into their frowns. Exciting but just the beginning! Although the press covered the study around the world few seemed to understand the science behind the experiment. Botox was an emotional molecule for many, which distracted attention from the real science behind the study. I realized that the message would need to be much clearer – so I began to write a book about the science  behind my study  and what led to my hypothesis– explaining why facial expressions could be used to treat depression, why frowning might send signals to the brain making one more depressed .Botox for Depression, Eric Finz, Faces of Emotion Last year I published “The Face of Emotion: How Botox Affects Moods and Relationships” (Palgrave Macmillan), providing a framework for understanding the therapeutic power of our facial expressions. In it I wrote:

The brain is measuring the strength of the frown muscle contraction, weighing it against the strength of the smile, which can been seen as the pulse of the positive feelings of happiness – and then producing an emotion. I call this emotional proprioception- just as your mind tracks the smallest movements of your hands or feet, it is tracking those little muscles that control your face.

Botox for Depression, Norman Rosenthall
The next step was to repeat my clinical trial, but this time with more patients and in a trial that was blinded and controlled. I had the good fortune to be introduced to a really open-minded and astute psychiatrist, Norman Rosenthal, a kindred spirit who had worked for many years at the National Institutes of Mental Health before heading up a clinical trial center. So Rosenthal and I began our fruitful collaboration and embarked on a controlled study of Botox depression with his fine team of psychiatrists. We entered 74 depressed people into a double blind, placebo controlled study and when we finally analyzed the data, the results were clear and strong.  Botox beat placebo, significantly reducing depression levels, regardless of whether patients were already on antidepressants (to which they had not responded) or were untreated.

The results of the study are due to appear in the Journal of Psychiatric Research in May 2014, but the abstract is already available online. READ THE ABSTRACT

As a son who watched helplessly as his mother suffered so miserably from depression, I am heartened at a potential new treatment option for this debilitating disease. And I am encouraged by discussion of our new study by Dr. Richard Friedman, in an Op Ed piece in the The New York Times Sunday Review section on March 23, 2014.   Only by much dialogue that generates interest among mainstream physicians will the research be propelled along. Although there are many available treatments for this very painful affliction, none were successful for my mother. I hope that, with replication of our findings, FDA approval will eventually follow, and someone else’s mother will be able to live a normal life.

Eric Finzi