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

 

Science of Smiling in HuffPost Healthy Living

Dr. Eric Finzi and Dr. Norman Rosenthal’s research study findings featured in The Science of Smiling by Andrew Merle for Huffington Post Healthy Living

When we are happy, our natural response is to smile. But if you flip that around, does the reverse hold true? When we smile, is our natural response then to be happy?

Science says yes.

In fact, even faking or forcing a smile reduces stress and makes you happier….

…Another study looked at the effect of facial expression on depression. The experimenters, Eric Finzi (cosmetic dermatologist) and Norman Rosenthal (professor of psychiatry at Georgetown Medical School) worked with 74 subjects who all had major depression, and either gave them a Botox injection between the eyebrows that prevented frowning, or a placebo saline injection that did not affect the facial muscles.

The findings showed that, six weeks after the injection, 52 percent of the non-frowning Botox group showed a reduction in their depression, compared to only a 15 percent improvement rate for the placebo group. The results indicate that putting on a happy face actually makes you happier.

It seems that the simple act of a physical smile, authentic or not, tricks your brain into thinking you’re actually happy. Smiling also triggers us to think back to joyful memories, further improving mood.

In addition to lifting mood and reducing stress, other research has shown that people who smile are thought to be more friendly and likeable, and smiling actually makes those around you cheerier as well.

All of this shows that the old sayings actually deliver great advice — it’s time to turn that frown upside down, grin and bear it, and say cheese!

LINK to Article

Botox for Depression, Eric Finz, Faces of Emotion

 

For more insight in to the study findings READ Dr. Eric Finzi’s Book, Face of Emotion: How Botox Affects Our Mood and Relationships

 

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.

Do We Frown Because We’re Depressed?

Michele Magid, MD

Michele Magid, MD, University of Texas Southwestern

Guest Blogger and Botox and depression researcher, Michele Magid, MD, (University of Texas, Southwestern) shares her insight on the phenomenon Psychiatrists around the globe are pondering in this blog post, “Do We Frown Because We’re Depressed, Or Are We Depressed Because We Frown?

Smiling makes us feel better! In a TED talk, researcher Ron Gutman discussed the facts that people with bigger smiles tended to live longer lives, have happier marriages, and appear more competent to others.1  In addition, smiling can reduce stress levels by decreasing cortisol, and improve mood by increasing endorphins.1 Gutman’s talk received criticism as it was unclear whether the link between smiling and success was correlative or causative.2

According to evolutionary theorist Charles Darwin and philosopher/psychologist William James, the relationship is causative—we are happy because we smile, we are sorry because we cry, and we are angry because we clench our teeth, not the other way around.3,4 In other words, changes in facial expression create and enhance emotion and are not merely a consequence of that emotion.

If facial expression can influence emotional experience, then what would happen if depressed patients were no longer able to frown?

Three recent studies5–7 (with sample sizes of 30 to 85) set out to answer this question. Male and female participants with major depressive disorder were injected with botulinum toxin A (BTA) into the forehead region, causing a reduced ability to frown (ie, paralysis of the corrugator and procerus muscles, which control expressions of fear, anxiety, and anguish). In all 3 double-blind, placebo-controlled trials, BTA was associated with a statistically significant reduction in depressive symptoms compared with placebo. More interestingly, in our 24-week trial,7 the antidepressant effects of BTA continued even after the cosmetic effects had worn off.

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

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

If botulinum toxin in the frown muscles improves symptoms of depression, why?

Some may argue that looking aesthetically better leads to feeling better, but our study7 excluded those with concern about their frown lines. Others argue that the more pleasant and less depressed we look, the more inviting we are to others, leading to improved social interactions and, subsequently, improved mood. These arguments, however, do not explain why mood continues to improve even when the BTA is no longer cosmetically active.

A final argument is that BTA in the forehead alters peripheral feedback to the brain. A recent study8 showed that people who were given BTA in the frown muscles had reduced activity in the left amygdala on functional magnetic resonance imaging (fMRI) when mimicking angry facial expressions. In theory, paralysis of the forehead muscles reduces sensory information from the trigeminal tract to the brainstem, which then alters activity between the brainstem and left amygdala. These findings are important as hyperactivity in the left amygdala has been linked to anxiety, depression, posttraumatic stress disorder, and heightened fear responses.9 In one study,10 20 depressed patients exhibited exaggerated left amygdala activity when shown pictures of emotional faces, especially fearful faces. After antidepressant treatment, left amygdala hyperactivity returned to normal.

Botox for Depression, Research, Dr. Eric Finzi, Dr. Norman E. Rosenthal, Botox, DepressionIs botulinum toxin a viable treatment option for major depressive disorder?

Regardless of whether one subscribes to a more behavioral or biological mechanism of action, further trials are warranted to determine if BTA is indeed a viable therapeutic option for depression and if specific patient populations are more likely to respond (eg, a recent study11 showed that higher agitation scores are predictive of response). If larger trials can replicate the findings of the 3 small trials, BTA may become a novel treatment in the management of major depressive disorder.

Financial disclosure: Dr Magid received grant/research support from the Brain and Behavior Institute, Young Investigator Award, to fund this study. After completion and as a result of the study, Dr. Magid became a consultant for Allergan.

References

1. Gutman R. The hidden power of smiling. TED Talks. March 2011.http://www.ted.com/talks/ron_gutman_the_hidden_power_of_smiling.

2. Grohol J. Ron Gutman: smiling while confusing correlation with causation.http://psychcentral.com/blog/archives/2012/08/19/ron-gutman-smiling-while-confusing-correlation-with-causation/.

3. Darwin, C. The Expression of the Emotions in Man and Animals. London, England: John Murray; 1872.

4. James, William. The Principles of Psychology. New York, NY: Henry Holt & Co; 1890.

5. Wollmer MA, de Boer C, Kalak N, et al. Facing depression with botulinum toxin: a randomized controlled trial. J Psychiatr Res. 2012;46(5):574–581. PubMed

6. Finzi E, Rosenthal NE. Treatment of depression with onabotulinumtoxin A: a randomized, double-blind, placebo controlled trial [published online ahead of print December 16, 2013]. J Psychiatr Res. Abstract

7. Magid M, Reichenberg JS, Poth PE, et al. Treatment of major depressive disorder using botulinum toxin A: a 24-week randomized, double-blind, placebo-controlled study. J Clin Psychiatry [published online ahead of print May 13, 2014]. Abstract

8. Hennenlotter A, Dresel C, Castrop F, et al. The link between facial feedback and neural activity within central circuitries of emotion—new insights from botulinum toxin-induced denervation of frown muscles. Cereb Cortex. 2009;19(3):537–542. PubMed

9. Shin LM, Liberzon I. The neurocircuitry of fear, stress, and anxiety disorders. Neuropsychopharmacology. 2010;35(1):169–191. PubMed

10. Sheline YI, Barch DM, Donnelly JM, et al. Increased amygdala response to masked emotional faces in depressed subjects resolves with antidepressant treatment: an fMRI study. Biol Psychiatry. 2001;50(9):651–658. PubMed

11. Wollmer MA, Kalak N, Jung S, et al. Agitation predicts response of depression to botulinum toxin treatment in a randomized controlled trial. Front Psychiatry. 2014;5:36. PubMed

Pacific Standard

Writer Taffy Brodesser-Akner tries Botox to treat her depression and shares her story with readers of Pacific Standard magazine in the July 2014 issue.

Pacific Standard July 2014

READ: Pacific Standard How Botox Can Help Solve the Depression Epidemic

 

Stephen Colbert on Botox for Depression

Botox for Depression is No Joke

Satirist Stephen Colbert recently joked about the Botox for Depression study findings in this Comedy Central  The Colbert Report entitled Cheating Death: Depression Edition. Study co-author, Dr. Norman Rosenthal, explains the science behind the research findings in this video.

Dr. Norman Rosenthal’s written BLOG on the subject:

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.

It 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.

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.

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.

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.

It 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.

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