According to a study by University of Miami Miller School of Medicine, the Moderna and Pfizer COVID-19 vaccines do not affect male fertility, which should help further address concerns about safety and adverse effects.

 is a barrier to ending the COVID-19 pandemic, and we believe some of that hesitancy is due to public opinion about whether the vaccine might negatively affect fertility,” said senior study author Ranjith Ramasamy, MD, associate professor and director of the Miller School’s Reproductive Urology Program.

Researchers studied 45 healthy male participants between the ages of 18-35 who received either the Moderna or the Pfizer-BioNTech. None of these men had any fertility issues at the study’s start. The participants provided a semen sample before receiving the first dose of either the Pfizer or Moderna vaccine, then provided another sample about 70 days after the second dose.

Researchers did not observe reductions in any sperm parameters, including semen volume, sperm concentration, sperm motility, and total motile sperm count.

“This is the full life cycle of sperm and 70 days is sufficient time to see if the vaccine impacts semen parameters,” said the study’s first author, Daniel C. Gonzalez, BSc, a medical student at the Miller School. “We measured semen volume, sperm concentration and the total amount of moving sperm and found there were no declines in any of the parameters as compared to the baseline analysis.”

The study’s findings suggest the Pfizer and Moderna vaccines do not impact male fertility. This could have huge implications for lowering vaccine hesitancy.

“We were the first to demonstrate that 

the COVID virus, itself, can affect male fertility

 and be a potential cause for erectile dysfunction. We are now the first to examine if there is any impact of the COVID vaccine on male fertility potential, which we did not find,” Ramasamy said further.

1. Gonzales DC, Nassau DE, Khodamoradi K, et al. 

Sperm parameters before and after COVID-19 mRNA vaccination

2. University of Miami Health System. University of Miami Miller School study shows COVID-19 mRNA vaccines do not impact male fertility. News release. June 17, 2021. Accessed June 23, 2021. 

https://www.newswise.com/coronavirus/university-of-miami-miller-school-study-shows-covid-19-mrna-vaccines-do-not-impact-male-fertility/?article_id=752972

3. Broderick JM. Study shows COVID-19 vaccines do not affect male fertility. 

. June 18, 2021. Accessed June 23, 2021. 

https://www.urologytimes.com/view/study-shows-covid-19-vaccines-do-not-affect-male-fertility

4. Hilton L. COVID-19 can invade testis tissue in some men who are infected with the virus, according to a new study by University of Miami Miller School of Medicine researchers published in The World Journal of Men's Health. University of Miami Health System. November 5, 2020. Accessed June 23, 2021. 

https://physician-news.umiamihealth.org/covid-19-can-infect-testes-with-potential-implications-for-male-fertility/

Articles

According to a recent study, COVID-19 vaccines did not impact sperm parameters. 

Vaccines Do Not Affect Male Fertility

holds a PhD in socioeconomics from the University of California, Los Angeles. He is the Chief Executive Officer of Landmark Research Group, LLC.

“Trauma eventually affects everyone on the planet,” says Randall Bell, PhD, who has worked on disaster recovery around the globe. But after the disaster, it is time to figure out how to survive, and then thrive.

In this Mental Health Minute, Bell discusses his latest book, 

Post-Traumatic Thriving: The Art, Science, & Stories of Resilience

. Marshalling a combination of scientific studies and personal stories, he lays out a 3-stage journey from trauma to recovery.

Videos

Is unresolved trauma the number one problem on planet earth? An economist with expertise in disaster-related distress makes the case. 

The Global Burden of Trauma

Canada just passed a law that has opened a path to euthanasia for patients with psychiatric illness who find their conditions unbearable. In your opinion:

If you have more to say on this subject, write us at 

Poll

What are your thoughts on medical aid in dying? 

Poll: Medical Aid in Dying

Precision medicine took another step forward as Adial Pharmaceuticals announced their intent to enter the genetic testing market. The news comes after the company received a Notice of Allowance from the US Patent and Trademark Office related to use of their genetic diagnostic panel in combination with their lead product, 

“This new patent related to the use of our genetic diagnostic panel in combination with AD04 for the treatment of AUD and OUD is a major milestone as we believe genetic evaluation of patients can be used to identify individuals that may benefit from AD04. We have been utilizing the genetic panel covered by this patent in our ongoing ONWARD™ Phase 3 trial, and, given this patent allowance, we anticipate that genetic diagnostics are expected to be an important segment of our commercial strategy going forward,” Adial’s CEO, William Stilley, said in a statement to the press. “Our view that AUD has a solid nexus in genetics is fundamental to the premise of the successful Phase 2B trial of AD04 conducted at the University of Virginia and our ONWARD™ Phase 3 trial of AD04 currently underway in Europe. And, it is consistent with Adial’s premise that the presence of certain genetics is expected to substantially influence whether an individual suffering from AUD or OUD would likely respond to treatment with AD04.”

 is a genetically targeted therapeutic agent for the treatment of AUD. The drug is designed to reduce cravings thereby reducing alcohol intake. patients curb their drinking. The oral medication will not require abstinence before or during treatment. To date, it has shown positive safety and tolerability profiles.

Once issued, the patent is anticipated to provide market exclusivity for the AD04 genetic diagnostic test. With this in mind, Adial plans to enter the genetic testing market as a stand-alone commercial business line and market the genetic diagnostic panel as a Companion Diagnostic Test to AD04. Approximately one-third (33%) of AUD patients are expected to respond to treatment with AD04.

In addition to the benefits for patients, the resulting efficacy may also realize cost savings to the health care industry. “Market research conducted by Adial indicates a willingness among payors to reimburse a genetic companion diagnostic test, and this may allow Adial to provide patients personalized, precision medicine and also potentially provide dramatic cost savings to payors,” Stilley said further.

1. Adial Pharmaceuticals. Adial Pharmaceuticals plans to enter genetic testing market following allowance of US Patent for genetic diagnostic test. News release. June 22, 2021. Accessed June 22, 2021. 

https://ir.adialpharma.com/press-releases/detail/122/adial-pharmaceuticals-plans-to-enter-genetic-testing-market

2. Adial Pharmaceuticals. Technology. Accessed June 22, 2021. 

Adial’s AD04 for the treatment of alcohol use disorder received a Notice of Allowance from the US Patent and Trademark Office. 

Patent Brings Psychiatry One Step Closer to Precision Medicine

is a physician consultant and Certified Peer Specialist in the Department of Psychiatry at McLean Hospital and the Massachusetts General Hospital. She is the author of four books and a blog on managing depression, most recently 

Helping Others With Depression: Words to Say, Things to Do (December 2020)

mental health and wellness virtual coaching practice, opening in July 2021, known as 

and can be confidentially reached through her website at 

Susan J. Noonan, MD, MPH, discusses what she learned from the Dalai Lama. 

mental health and wellness virtual coaching practice, opening in July 2021, known as Noonan Wellness Coaching,and can be confidentially reached through her website at 

According to the Dalai Lama, physical care is not enough to achieve wellness. 

Compassion in Medicine: Lessons From the Dalai Lama

is a principal and cofounder of Atlanta Financial Associates. She specializes in working with physicians and executives in the health care industry.

Many physicians falsely believe that retirement planning will be easy because they are high-income earners. However, high income does not guarantee smart money management, and even physicians aren’t immune to making financial missteps. To ensure financial health, physicians should avoid these common retirement planning mistakes.

 Medical school and residency may prevent physicians from entering their earning years until their mid-30s. As such, clinicians have less time to accumulate savings, and savings have less time in the market to compound. Unfortunately, for many young residents, socking away for retirement tends to take a back seat to purchasing a home, starting a family, or simply not having to live frugally. In order to counteract getting a late start, physicians will need to increase their savings rate and begin funding their retirement savings as soon as possible.

 Because physicians are high earners, they usually enjoy a higher standard of living that they would like to maintain in retirement. In order to live a comparable lifestyle over an extended retirement period, physicians need to find ways to accelerate their savings. Although it is commonly recommended that the average person saves 10% of their income, physicians need to save closer to (if not higher than) 20%.

 The purpose of retirement planning is to accumulate adequate resources to fund your life, post career, without running out of money, not to fund short-term goals, such as buying a house or sending a child to college. Sometimes tunnel vision conquers willpower, however, and people borrow from their 401k fund. Not only does this postpone savings goals, but it also brings a potential tax burden and penalty fees. 

 Even physicians are susceptible to underestimating the escalating cost of health care. The rate of increase of health care costs has long surpassed the average annual increase in Americans’ income. According to a March 2019 study published in the Journal of the American Medical Association, health care spending in the United States was $3.5 trillion, or about $11,000 per person, in 2017. By 2027, these costs are expected to reach $6 trillion, or $17,000 per person.

 Physicians, like many people, may not be vigilant about preparing personal estate planning documents. Pertinent documents include your financial powers of attorney, medical directives to be used while you are alive, and a will to make your wishes known for the disposition of your estate after your death. In the absence of these documents, your family could be exposed to making tough medical decisions on your behalf, a lengthy probate process, and costly attorney fees, all of which could be significantly injurious to their financial well-being.

 Saving for retirement is one of the most important and difficult financial decisions people face. With retirement periods extending alongside rising life expectancies, the ability to accumulate adequate resources to provide yourself with a financial cushion no matter how long you live is becoming increasingly challenging. A trusted advisor can point you in the right direction—not only from a financial perspective, but from a personal one.

Are you properly planning for retirement? 

Avoid These Common Retirement Mistakes

crafting a portrait of a Medico della Peste,

to drown the stench, his waxed black cloak

they worshipped. And I wonder if today’s

and robe, would the Inquisition have seen

he held out to the world like an offering?

has been writing a poem about his experience of being a doctor every month for the past 23 years in 

 in a column called “Poetry of the Times.” He is instructor in psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts.

"While I watch the artist paint, I imagine him in the time of plague..."

Modern Medieval Artist

is professor of psychiatry and the Former Von Tauber Chair,

Psychiatry & Behavioral Sciences at Nassau University Medical Center.

My wife and I sat down to watch the news on a pleasant summer evening in 2020. That day’s contents included reports about multiple deadly hurricanes in the Gulf of Mexico, wildfires in California, and racial riots in big and small cities across the United States. Simultaneously, the world dealt with the COVID-19 pandemic that had killed 1.3 million individiuals worldwide and 230,000 in the United States, as of November 2020.

Signs of the devastation wrought by the pandemic were ubiquitous. Hospitals were overflowing with severely ill patients, and the staff had to use temporary morgues in huge, refrigerated trucks. Consequently, there was a higher incidence of physical and psychiatric illnesses, even in those not infected by the virus. Millions lost their jobs, and there was no end in sight to this agony. Quite fortuitously, our 20-month-old granddaughter came to our rescue with her intelligence, loveliness, curiosity, and guilelessness.

Before describing how a toddler living 1000 miles away can salvage her grandparents’ sagging spirits, let me provide the context. My wife, a computer professional, and I, a psychiatrist, became empty-nesters when our daughter left home to study medicine this past summer. In choosing medicine as her career, our daughter followed her physician brother’s footsteps. Our son is married to his classmate in college, also a physician, and the couple has a lovely 20-month-old daughter, Mia. Mia is a beautiful baby with chubby cheeks, large eyes, an expressive face, and a full head covered with unruly, curly, dark hair. She is very curious about the world around her. Mia loves the outdoors and often asks her parents to take her to their backyard, where she runs around with boundless energy. Nothing escapes her attention, whether it be an airplane flying in the distant sky, a helicopter hovering low nearby, or beautiful birds sitting on tree branches.

Mia is a ray of sunshine in an otherwise bleak current environment. Her parents call us several times a week. Our son and daughter-in-law live in Nashville, TN, and we live on Long Island, NY, making video chats via phone/computer the only link between us. We are grateful for these video chats in our lives because they offer us such an enriching experience.

While watching the news on that late summer evening, the phone rang with FaceTime’s familiar sound. Momentarily, we saw Mia seated in a highchair waiting for her dinner and looking particularly for her grandmother, whom she calls “Ammanna.”

What happened next profoundly touched me. Mia turned towards her father and said, “

 has an Ouchy!” Clouds of worry eclipsed the joy on her face. She started to suck on her fingers, which is what she does when she is anxious, and stopped being playful. She extended her little hand as though she wanted to touch my face through the phone to reassure herself that I was okay. The band-aid that I had on my face—remnants of a shaving accident on my chin that morning—caused her alarm. I told her I was okay.

Mia had finished with me and turned her attention back to her Ammanna while removing her fingers from her mouth. She began her chant of “

, and chimes” (flower and windchime). My wife apologized to Mia for the delay, and armed with her phone, set out for a walk around our garden to show the colorful flowers. Mooch, our miniature poodle, marched behind.

We have a beautiful flower garden, a moderate-sized deck, and a pergola with a wind chime. By now, Mia had learned to accurately identify each plant’s location in the garden and its flowers’ color. She would exclaim 

 (yellow), red, purple, pink, white, and orange—naming flowers of various varieties as her grandma went around the garden. If her Ammanna missed any color, Mia would demand to see that flower again. While the tour of our garden is in progress, Mia is making sure that her Appa in their kitchen by her side did not miss any of the action by quizzing him, “Did you see that?” Her father answers, “Yes, I did. Did you see that? Isn’t that beautiful?” Mia nods her head to express her appreciation of her father’s attentiveness by saying, “What a guy!”

Mia, her Ammanna, and Mooch finished seeing the flowers to Mia’s satisfaction; her grandmother walked up to the pergola where the wind chime hung. The rods’ continuous chiming made her ecstatic.

As Mia began to eat, somewhat reluctantly, she yawned, looking sleepy and tired. My son said, “Say good night to Tata and Ammanna.” She looked at my son as though she was imploring him to let her stay with us for a few more minutes while fighting a second yawn. My son was firm in his instruction, and Mia said reluctantly good night to us. Also, my ouchy was cured due to the caring and love I saw in her eyes. My wife and I felt sad and turned off the phone with the knowledge that in another 24 hours, Mia would be back again, bringing more joy to her Ammanna and Tata.

Given the past few months’ experience, one could say life is full of tragedies, famines, fires, pandemics, and illnesses. However, it also has beautiful moments. As per Donald Winnicott, MD, the British psychoanalyst, who used the term 

 to refer to the supportive environment that a therapist creates for a client, one can liken holding to the nurturing and caring behavior a mother engages in with her child, which results in the sense of trust and safety in the child.

Due to the advanced modern technology like Facetime, changing lifestyles, and the stresses of contemporary life, the caretaker’s circle can include extended family and friends. Such loving individuals’ involvement will enhance the baby’s self-esteem, diminish her stranger anxiety, and improve her communicational and empathic skills.

In India, where we come from, the elderly and retirees’ lives can be quite hectic because of their active involvement in raising their grandchildren. There’s a cultural acknowledgment that the elderly are repositories of wisdom and life experiences, and 

80% of the elderly live with their children

 For Indians, empty nesting is not a familiar life experience. Grandparents spend their time on family, social, and spiritual activities. The grandchildren learn about living in a complex society through multiple interactions with their elders more than they would in school.

My wife and I came to the United States 42 years ago. As we look into the future, we miss the wise presence of the family elders. We miss the absence of the noise and chaos of India. The silence in empty-nester homes like ours is deafening. The opportunity to witness the development of Mia’s personality is a gift to us from our children. One more day has passed in this endless march of events in the pandemic, but we were able to live our lives without the madness on the streets touching us. Thank you, Mia!

is professor of psychiatry and the Former Von Tauber Chair, Psychiatry & Behavioral Sciences at Nassau University Medical Center.

The Child, the Family, and the Outside World.

2. Biswas S. Why Indians continue to live in joint families. September 14, 2020. Accessed June 22, 2021. 

https://www.bbc.com/news/world-asia-india-54053091

During the pandemic, this psychiatrist is only able to connect to his beloved grandchild through FaceTime. He considers it a blessing. 

The Empty Nesters, The Pandemic, and Mia

 investigated the genetic basis for both migraine and posttraumatic stress disorder (PTSD) by examining identical twins.

Researchers discovered there are common genes and pathways shared by PTSD and migraine, which may suggest they share some risk factors, thus in part explaining the comorbidity of the 2 conditions.

“Our results suggest that common genes and signaling pathways are involved in PTSD and migraine and this might explain why PTSD and migraine can cooccur frequently,” said senior author on the study, Divya Mehta, PhD, of the Queensland University of Technology. “This might further imply that common environmental risk factors for both PTSD and migraine might be acting on these genes.”

The study observed 6 pairs of monozygotic (MZ) twins discordant for PTSD and 15 pairs of MZ twins discordant for migraine. PTSD was measured through phone interviews conducted by an experienced interviewer using structured questions and DSM-IV criteria. All 6 pairs of twins were identified as having experienced a PTSD-qualifying potentially traumatic event as per the DSM-IV criteria. Migraine was assessed using the International Headache Society (IHS) diagnostic criteria, the International Classification of Headache Disorders, ICHD-3, together with a diagnosis of migraine with or without aura. Pairs of twins discordant for migraine with aura were chosen for the study.

Blood samples were taken from all participants. Association between DNA methylation and PTSD status was tested using linear mixed effects models with age, sex, and cell counts as covariates. Using the same study design as the PTSD sample of twins, the 15 pairs of MZ twins discordant for migraine were tested for association of methylation at genetic loci that overlap between PTSD and migraine using varied analyses.

At the epigenome-wide level, researchers assessed how many of the 1036 genes associated with PTSD overlapped with those significantly associated with migraine in the discordant migraine MZ twins.

“We identified DAPK2 and TM6SF2 as two of the top overlapping genes between the two disorders. DAPK2 is a calmodulin-regulated protein kinase, it has been implicated in the intracellular degradation process essential for adaptation to metabolic stress (autophagy). TM6SF2 is associated with cardiovascular disease and plays a role in oxidative stress. These findings suggest that epigenetic changes in response to different types of stress may ‘mediate’ stress phenotypes,” said the study’s authors.

The findings could form the basis for new treatments. Epigenetic changes offer an excellent drug target, as they can often be reversed.

“These results may have implications for treatments, as one medicine or therapy might only be effective for a single disorder,” said Mehta. “For co-occurring disorders such as PTSD and migraine, once we know which common genes are implicated in both disorders, we can develop new therapeutics to target these, thereby reducing symptoms and curing both.”

1. Bainomugisa CK, Sutherland H, Parker R, et al. Using monozygotic twins to dissect common genes in posttraumatic stress disorder and migraine. 

https://doi.org/10.3389/fnins.2021.678350

2. Frontiers. Twin study is first to reveal common genetic risk factors for PTSD and migraine. News release. June 22, 2021. 

https://blog.frontiersin.org/2021/06/22/neuroscience-twins-genes-risk-ptsd-migraine/

Genes may hold the answer to the puzzling comorbidity of migraines and posttraumatic stress disorder. 

Are Migraines and PTSD Linked? 

Jaya Jaya Myra is a best-selling author, TEDx & motivational speaker, and mind-body wellness expert teaching the definitive connections between purpose and health. Her debut book, 

Vibrational Healing: Attain Balance & Wholeness. Understand Your Energetic Type

 is published in 10 languages and available worldwide. Her 2nd book, 

, is slated for publication January 5th, 2021.

Jaya Jaya Myra discusses yoga at large and the philosophy behind it. 

 is a best-selling author, TEDx & motivational speaker, and mind-body wellness expert teaching the definitive connections between purpose and health. Her debut book, 

International Yoga Day: Mind, Body, Soul Wellbeing 

Is It a Psychiatric Disorder or a TBI Medical Mimic?

Too often, the medical issues associated with traumatic brain injury (TBI) are mistaken for psychiatric disorders, and patients are mistakenly referred to psychiatrists for treatment, Gregory J. O’Shanick, MDDLFAPA, told attendees.

O’Shanick, medical director of the Center for Neurorehabilitation Services in Richmond, Virginia, reminded psychiatrists to leverage their medical knowledge when assessing patients to help distinguish TBI-related medical mimics and true psychiatric diagnoses.

As the prevalence of TBI has increased, so too has 

research linking psychiatric disorders and TBI

 Jennie Ponsford, PhD, and colleagues explored this phenomenon and found that only about 23% and 21% of individuals had a pre-TBI history of a mood disorder or an anxiety disorder, respectively.

 They found an increase in psychiatric symptomology within the first year after TBI; mood and anxiety symptoms were most common (prevalence, 17.2%-62.0% and 10.3%-34.2%, respectively). Interestingly, O’Shanick noted depression is 4 to 6 times more common in patients with TBI than in the general population, and it is the most common cause of depression in men.

It is possible, he explained, that some of these mood disturbances and anxiety symptoms may be better explained as a medical consequence of TBI—or a signal of homeostatic disruption. In such cases, providing psychopharmacological treatment might improve symptoms but will not address the underlying cause.

To illustrate this issue, O’Shanick discussed examples of phobias misattributed to psychiatric diagnoses. For instance, if an individual has unrecognized balance and visual issues as a result of TBI, they may feel a sense of anxiety when in crowds. Instead of recognizing that the uneasiness is due to stability issues, the person may inappropriately link the feeling to an anxiety disorder.

“As physicians, we need to figure that out,” O’Shanick emphasized.

Fortunately, a few simple questions and exercises can help determine the root cause of the psychiatric symptoms. For example, to determine if agoraphobia symptoms may actually be vestibular in nature, ask your patient if they need to touch the wall to prevent falling when closing their eyes in the shower. Or, if the patients feels anxious in a crowded area like a store or mall, ask if pushing a cart or stroller, or holding on to another person, makes them feel better. If they answer yes, a few simple follow-up tests (eg, the Balance Error Scoring System and Fukuda Stepping Test) can confirm the presence of the medical mimic. Referrals for vestibular physical therapy and a neuro-ENT consultation may prove useful for such patients.

Similarly, to determine if there is social phobia or vergence, ask your patient if they are having trouble seeing or reading books at a normal distance. Then, check their near point of convergence and conduct a cover test. Consider a referral to a neuro-optometrist.

In other cases, a central auditory processing disorder may be confused with attention-deficit/hyperactivity disorder. Ask your patient if they have better sustained attention for visual vs verbal interactions, or if they have trouble understanding what people say if they cannot see their faces or mouths. Weber and Rinne tests can also prove useful, and a referral to an audiologist is indicated.

Posttraumatic neuroendocrine (PTNE) disorders may be relatively common in patients with TBI,

 and mood symptoms are associated with PTNE, O’Shanick explained. Psychiatrists should inquire about changes in menses, sex drive, cold intolerance, and skin and hair dryness to elucidate if PTNE is a potential cause of the mood symptoms. Lab studies should be considered, including free thyroxine, thyroid-stimulating hormone, follicle-stimulating hormone, luteinizing hormone, immunoglobulin-1, estradiol/testosterone, and AM/PM cortisol. In considering TBI in these cases, O’Shanick reminded attendees that they should not overlook intimate partner violence and child abuse.

Finally, O’Shanick illuminated the inherent biases in the Minnesota Multiphasic Personality Inventory-2 that could lead to incorrect diagnoses. For instance, stomach trouble and headaches score positively on the hypochondriasis scale, but both of these symptos may be related to TBI and TBI treatments. Similarly, positive scores on the hysteria scale result from the patient noting they are unable to work, feel sad, and have trouble sleeping, all of which are associated with TBI.

Ultimately, the psychiatrist is in the ideal position to leverage their medical and behavioral knowledge to support these patients.

“Hopefully, [these insights] will allow you to think a little bit differently when patients come into your office,” O’Shanick concluded. “Maybe ask some increased questions when it comes to injury-related issues, concussion-related issues… to see if there are some other types of medical issues behind some of the anxieties that your patients have. At the end, you may just find that you’re practicing … much more successfully and ultimately helping your patients.”

1. Surveillance report of traumatic brain injury-related emergency department visits, hospitalizations, and deaths. CDC. 2014. Accessed May 2, 2021. 

https://www.cdc.gov/traumaticbraininjury/pdf/TBI-Surveillance-Report-FINAL_508.pdf

2. Ponsford J, Alway Y, Gould KR. Epidemiology and natural history of psychiatric disorders after TBI. 

3. Beyer C, Zaytsev J, Donegan D, et al. The effects of traumatic brain injury on pituitary function: a systematic review and meta-analysis. 

Ketamine: Not a Simple Treatment, but a Worthy One

"This is not a simple treatment or a treatment to take lightly,” Richard C. Shelton, MD, said during the Q+A portion of the presentation “Ketamine for Depression: Is the Hype Holding Up? Mechanisms and Evidence.” “On the other hand, we’ve seen remarkable results.”

Shelton, director of research of the Huntsville Regional Medical Campus of the University of Alabama, Birmingham (UAB), School of Medicine; the Charles B. Ireland Professor in UAB’s Department of Psychiatry and Behavioral Neurobiology; and director of the UAB Depression and Suicide Center, began with a discussion of ketamine’s functions in the brain. He discussed how it restores the regulatory processes for patients with depression and other mood disorders, using the results of a 

“Stressful experiences cause a reduction or retraction of spines and synapses. The brain is less able to control or regulate the emotional state,” Shelton explained.

With ketamine administration, there is an almost immediate increase in formation of critical spine and synaptic proteins.

“When you add ketamine to the system, you produce a rapid return and restoration of those spines and synapses. We see an effect within 24 hours,” Shelton continued. “Ketamine has the ability to restore the regulatory control to the brain and helps, theoretically, to normalize mood.”

Shelton shared data from 8 studies that investigated ketamine; they found ketamine produced a rapid, robust effect for patients with severe treatment-resistant depression.

 Data from additional studies demonstrated how ketamine functioned for patients with suicidal ideation.

“The good news: Ketamine really seemed to work in these patients with highly treatment-resistant depression,” Shelton said.

Shelton also addressed key concerns regarding ketamine, especially how it may be a challenge to prescribe. First, the US Food and Drug Administration requires a “somewhat cumbersome” risk evaluation and mitigation strategy program, which requires registration by the clinic, provider, and patient. There are prior authorization hurdles as well as reimbursement issues, he added. Nonetheless, Shelton finds ketamine is more than worth the attendant logistical struggles.

“When I treated my first patient with IV ketamine in 2012, it was just amazing to see the effect occur within 24 hours,” Shelton said.

1. Li N, Liu R-J, Dwyer JM, et al. Glutamate N-methyl-D-aspartate receptor antagonists rapidly reverse behavioral and synaptic deficits caused by chronic stress exposure.

2. Berman RM, Narasimhan M, Sanacora G, et al. A randomized clinical trial of repetitive transcranial magnetic stimulation in the treatment of major depression. 

3. Zarate CA Jr, Singh JB, Carlson PJ, et al. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. 

4. Singh JB, Fedgchin M, Daly EJ, et al. A double-blind, randomized, placebo-controlled, dose-frequency study of intravenous ketamine in patients with treatment-resistant depression. 

5. Daly EJ, Singh JB. Adjunctive intranasal esketamine in treatment-resistant depression—reply. 

6. Fedgchin M, Trivedi M, Daly EJ, et al. Efficacy and safety of fixed-dose esketamine nasal spray combined with a new oral antidepressant in treatment-resistant depression: results of a randomized, double-blind, active-controlled study (TRANSFORM-1). 

7. Popova V, Daly EJ, Trivedi M, et al. Efficacy and safety of flexibly dosed esketamine nasal spray combined with a newly initiated oral antidepressant in treatment-resistant depression: a randomized double-blind active-controlled study. 

8. Daly EJ, Trivedi M, Janik A, et al. Efficacy of esketamine nasal spray plus oral antidepressant treatment for relapse prevention in patients with treatment-resistant depression: a randomized clinical trial. 

9. Wajs E, Aluisio L, Holder R, et al. Esketamine nasal spray plus oral antidepressant in patients with treatment-resistant depression: assessment of long-term safety in a phase 3, open-label study (SUSTAIN-2). 

10. Wilkinson ST, Ballard ED, Bloch MH, et al. The effect of a single dose of intravenous ketamine on suicidal ideation: a systematic review and individual participant data meta-analysis. 

11. Canuso CM, Singh JB, Fedgchin M, et al. Efficacy and safety of intranasal esketamine for the rapid reduction of symptoms of depression and suicidality in patients at imminent risk for suicide: results of a double-blind, randomized, placebo-controlled study. 

12. Fu D-J, Ionescu DF, Li X, et al. Esketamine nasal spray for rapid reduction of major depressive disorder symptoms in patients who have active suicidal ideation with intent: double-blind, randomized study (ASPIRE I). 

13. Ionescu DF, Fu DJ, Qiu X, et al. Esketamine nasal spray for rapid reduction of depressive symptoms in patients with major depressive disorder who have active suicide ideation with intent: results of a phase 3, double-blind, randomized study (ASPIRE II). 

Experts Express Concern Over Excited Delirium Syndrome Diagnosis

There is universal confusion around excited delirium syndrome (ExDS): What is it and how should it be treated? In short, we do not know all the answers, and no comprehensive treatment guidelines or formal criteria exist, according to a panel presentation. Representing the fields of emergency medicine, psychiatry, psychology, and emergency medical service (EMS), the expert panel consisted of Leslie Zun, MD, MBA; Thom Dunn, PhD; Julie Owen, MD, MBA; and Sarah E. Slocum, MD.

Recent events have brought to light the importance of clarifying the differential diagnosis, signs and symptoms, and universal treatment protocols of ExDS, which to date remain unclear.

In the last year, the world witnessed George Floyd dying at the hands of a police officer. In 2019, Elijah McClain, aged 23 years, a massage therapist, was placed in a chokehold by law enforcement and sedated by EMS with 500 mg of ketamine, a tactic that is legal in Colorado to control ExDS. By the time he arrived at the hospital, he was brain dead; he died 3 days later.

How McClain died is a matter of dispute, but 1 thing is clear: These and many, many more incidents in the public eye have shone a spotlight on the use of force by police and in emergency settings.

Dunn, a psychologist who is involved in emergency medical services, shared an ultimately tragic example of ExDS in a hospital setting in which an adult male Black patient demonstrated signs of the condition. The presence of police seemed to intensify the patient’s agitation. He began to sweat profusely, stripped naked, shouted incomprehensibly, and flailed his arms. After multiple attempts to restrain him, police tased him. Emergency staff then administered ketamine, and he subsequently died.

In 2020, the American Psychiatric Association released a 

DSM-5 recognizes Delirium, hyperactive type, but the symptoms of this condition differ in many ways from the symptoms typically attributed to excited delirium (eg, superhuman strength, impervious to pain, etc). Recent data suggest that persons being detained by the police and described as having ‘excited delirium have frequently received medication from emergency medical technicians (EMTs) intended to rapidly sedate them…In some reported cases, it is questionable whether the person identified as having an ‘excited delirium’ actually had any medical condition warranting its use.

The discussion concluded with Slocum’s call for action: “We really need to address this condition as a group and figure out what’s going to be best for that patient.”

1. American Psychiatric Association. Position statement on concerns about use of the term “excited delirium” and appropriate medical management in out-of-hospital contexts. December 2020. Accessed May 22, 2021. 

https://www.psychiatry.org/File%20Library/About-APA/Organization-Documents-Policies/Policies/Position-Use-of-Term-Excited-Delirium.pdf

"Ethical dilemmas arise when multiple ethical responsibilities stand in tension with each other,” Charles Dike, MBChB, MPH, told the attendees.

During the discussion, one issue stood out: the possible conflict between psychiatrists’ duties to their individual patients and their duties to promote the good of the public as a whole.

This conflict has become particularly pressing this past year due to the global pandemic, and the panelists considered the problem from several angles as they answered previously submitted questions.

One question concerned confidentiality: What should be done when a patient reports that their parents are sending the patient’s sibling to school, despite the child’s positive SARS-COV-2 virus results?

Daniel J. Anzia, MD, a member of the expert panel, explained, “The participation in public health endeavors is a long-standing, recognized potential exception to the obligation of psychiatrists, and all physicians, to maintain confidentiality.” Past department chair for psychiatry at Advocate Lutheran General Hospital in Park Ridge, Illinois, Anzia said that ideally, the patient—who was no longer a minor—would make the report to the school, and then inform the family that public health officials might be contacting them. But, he added, if the patient refused, “it is permissible for the psychiatrist to make such a report.”

Another questioner asked what psychiatrists should do if patients insisted on being seen in person, even at the height of the pandemic. Panel member Patricia (Tia) Powell, MD, director of the Montefiore Einstein Center for Bioethics in the Bronx, New York, told attendees that they are not required to put themselves at physical risk. “Among our many obligations as psychiatrists is to provide a safe space in which we can offer therapy for our patients. That includes keeping the patient and psychiatrist safe from each other in terms of communicating the virus,” she explained.

In addition, Powell noted that many psychiatrists have extended their knowledge and use of telehealth, discharging their obligation to offer care in person by working with patients to make telehealth possible. If the patient refuses telehealth, protective gear, and vaccination, she said, “it could be legitimate for a psychiatrist to say, ‘At this time, I’m not able to continue working with you.’”

Similarly, are psychiatrists obligated to get an available COVID-19 vaccine? Although “a psychiatrist has a right to refuse the vaccine, the psychiatrist should consider their wider obligations of such a decision, including an unspoken statement—to the psychiatrist’s colleagues and patients—that the psychiatrist does not trust the vaccine,” said Dike, associate professor of psychiatry at Yale School of Medicine and associate program director of its Law and Psychiatry Fellowship. “This could discourage vulnerable patients from taking what could be a life-saving intervention.”

What are the obligations of a psychiatrist to a new patient who has yet to be seen? The panel was presented with a situation in which a new patient reports suicidal thoughts on a previsit questionnaire, and then does not come to the appointment or answer calls. Should the psychiatrist send someone to check on the patient?

Panelist Rebecca Brendel, MD, JD, detected a potential conflict between the psychiatrist’s duty to the individual patient and the public at large. “We’d hate to say we’re not going to screen patients for suicidality because it’s too hard to figure out what to do with the information,” explained Brendel, assistant professor of psychiatry at Harvard Medical School and director of its Master in Bioethics program. However, she noted the need for a follow-up mechanism that does not overstep the bounds of a nascent doctor-patient relationship by violating the prospective patient’s rights to privacy and confidentiality.

One of the more controversial topics over the past few years has been what psychiatrists—or, more broadly, the APA—should say about the national psyche and potentially dangerous political leaders or movements. Brendel quickly reaffirmed the Goldwater Rule, but she also insisted that “psychiatrists can participate in public life by adding insight and knowledge about mental health more generally.” For instance, psychiatrists might use their knowledge of history and psychology to “comment about what might lead groups of persons to become susceptible to certain beliefs, [or] be prone to questioning authority in violent ways. [Psychiatrists can] also…be thinking about how unrest or extremism or discriminatory views might affect certain members of our society, and in particular their mental health.”

The panel reminded attendees that ethics resources and official APA opinions can be found on the APA’s Ethics webpage: 

https://www.psychiatry.org/psychiatrists/practice/ethics

. Queries can be submitted to the APA’s Ethics Committee staff liaison for further guidance at apaethics@psych.org. Alternately,

readers can submit ethical dilemmas to our Ethics Editor via 

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