Our easy-to-read fact sheets provide clinicians with reliable information to share with patients and their caregivers.
Postpartum depression is defined as the onset of major depression associated with childbirth that negatively affects the mood and behavior of the parent.1 During pregnancy, an individual undergoes considerable hormonal fluctuations, including increased levels of estrogen and progesterone. After childbirth, these hormone levels drop rapidly, which can contribute to the onset of postpartum depression. Additionally, the postpartum period is often accompanied by increased stress due to the demands of caring for a newborn, sleep deprivation, and hormonal changes.
For new parents battling postpartum depression, finding the right medication to manage your condition can be a critical step towards healing and supporting your mental health. Our helpful guide aims to inform patients about the risks, benefits, and considerations associated with postpartum depression medication as they begin their recovery.
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For new parents battling postpartum depression, finding the right medication to manage your condition can be a critical step towards healing and supporting your mental health.
Major Depressive Disorder
Depression is a general term for a common psychiatric disorder that presents with symptoms such as sadness, irritability, loss of interest in activities, feelings of worthlessness, hopelessness, guilt or anxiety, concerns over death, and/or suicidal ideation. Individuals with depression may also experience fatigue, difficulty concentrating, and changes in their appetite weight, and sleep.2
Major depressive disorder, or MDD, is characterized by a sad mood and/or lack of interest in activities. A diagnosis of MDD requires the presence of at least 5 of the key symptoms for most of the day, nearly every day, or for at least 2 weeks.1,3
Postpartum Depression
Postpartum depression is classified as a major depressive disorder that begins during or after childbirth, typically within the first 3 months and up to 1 year after childbirth. Approximately 15% to 20% of childbearing individuals develop postpartum depression each year. Although it is one of the most common complications of the postpartum period, it is often underdiagnosed and undertreated.1,4
Symptoms of postpartum depression may overlap with MDD, but include unstable mood, anxiety, irritability, extreme sadness, decreased pleasure, low energy, as well as obsessive worry – typically about the baby’s health, feeding, and safety. More serious symptoms that require immediate evaluation by a provider are thoughts about self-harm, suicide, or harming one’s child.1,3,4
While the exact cause of postpartum depression is not fully understood, several key factors contribute to its development:5,6
Hormonal Changes: Hormonal fluctuations during and after pregnancy can impact neurotransmitter levels in the brain, which play crucial roles in regulating mood
Genetic Predisposition: Individuals who have a family history of depression or mood disorders are at higher risk for postpartum depression
Psychological Factors: Psychological factors, such as a history of depression or anxiety, can increase the risk of developing postpartum depression. Additionally, stressors related to childbirth, such as difficult labor, pregnancy complications, or concerns about parenting, can contribute to the onset of depression
Social Support and Stress: Lack of social support, relationship difficulties, financial strain, and other stressors can exacerbate the risk for postpartum depression
Physical Health: Vitamin D deficiency, gestational diabetes, obesity, chronic health conditions, sleep disturbances, or health complications during pregnancy or childbirth can also contribute to the development of PPD
Medication Options
If you are experiencing symptoms of postpartum depression, speak with your provider to discuss treatment options. Currently, antidepressants in combination with psychotherapy are recommended to treat moderate-to-severe depression.1 Commonly used postpartum depression medication options include the following:
Nortriptyline is a TCA that inhibits reuptake of norepinephrine and serotonin into the neurons to increase their levels, as well as inhibit the activity of other agents.
Mirtazapine is an atypical antidepressant that works as an antagonist at central presynaptic a2-adrenergic receptors to enhance noradrenergic and serotonergic activity.
Sleepiness or drowsiness Increased appetite Weight gain Dizziness
Brexanolone and zuranolone are medications approved for treatment of postpartum depression. They work on the GABAA receptors to regulate mood and behavior.
Sleepiness or drowsiness Dry mouth Passing out Flushing of the skin or face Dizziness Fatigue Diarrhea Common cold Urinary tract infection
It's important to recognize that postpartum depression is a complex and multifaceted condition that varies from person to person. Although the transition to parenthood can be challenging for many individuals, when symptoms persist and significantly impact daily functioning, it may indicate the presence of postpartum depression. Seeking professional help is crucial for diagnosis and treatment.
Frequently Asked Questions
How can I tell if I’m experiencing postpartum depression?
If you think you may have postpartum depression, it is important to speak with your provider. Your provider can provide a clinical assessment or utilize self-report tools, such as the Edinburgh Postnatal Depression Scale (EPDS) – a widely and reliably used screening tool for postpartum depression.15 Physicians are encouraged to screen for postpartum depression at the first postnatal obstetrical visit. If you or a loved one are experiencing symptoms of postpartum depression, follow-up with your provider to discuss diagnostic and treatment options.
Are these medications safe for me to take while breastfeeding?
It is recommended that patients who are currently breastfeeding, or planning on breastfeeding, should first speak with their provider to discuss the potential risks and benefits of different medication options. The decision to use antidepressants during postpartum while breastfeeding involves careful consideration of both the potential risks and benefits for both the parent and the baby.
Treating postpartum depression with antidepressants can improve parental mental health and reduces the risk for paternal self-harm or harm to their child. However, some medications can pass into breast milk.10-13 There is ongoing research regarding the long-term effects of antidepressant exposure during breastfeeding on infant development. While some studies have suggested potential concerns, the overall consensus is that the benefits of breastfeeding typically outweigh the potential risks for antidepressant exposure.
For example, sertraline and paroxetine have a better safety profile for infants during breastfeeding, but there is less available data for other serotonin reuptake inhibitors such as escitalopram and duloxetine.1,8 When taking fluoxetine, it is recommended to monitor infants for agitation, irritability, poor feeding, and poor weight gain.16 Research also indicates that zuranolone has potential risk for harm to the infant. It is recommended to use effective contraception during zuranolone treatment and for 1 week after the final dose.14
In many cases, the benefits of treating postpartum depression with antidepressants outweigh the potential risks, but it's important to carefully consider all factors and explore alternative treatments if appropriate.
When should I stop taking my medication?
It is important to consult your provider before discontinuing treatment. Discontinuation during pregnancy may increase your likelihood of a depression relapse, compared with individuals who continue antidepressants.11,12 However, if you experience new or worsening depression, anxiety, irritability, insomnia, mania, or suicidal thoughts and behavior, you should speak with your provider to determine if this is a side effect of your medication.
Newer postpartum depression medications such as Brexanolone and Zuranolone have specific durations of therapy. Zuranolone should only be taken once daily for 14 days while brexanolone is administered as a continuous infusion over 60 hours (2.5 days).13,14
You should stop taking your medication and seek immediate medical help if you experience a seizure or an allergic reaction such as development of skin rash, hives, chest pain, edema, and shortness of breath.
As physicians and researchers continue to refine their understanding of autism spectrum disorder (ASD), increasing evidence is shedding light on the distinct manifestation of autism symptoms in women.1 Because of the historical emphasis on the stereotypical presentation of ASD among boys and men, women with ASD have often been overlooked or misdiagnosed due to the unique behavioral patterns and challenges faced by women with ASD.
This has contributed to the development of a sex and gender bias in which neurodevelopmental conditions are diagnosed at a significantly higher rate for boys/men compared to girls/women. In particular, ASD has a 1% prevalence in children with a 3:1 boy-to-girl ratio.1
Correspondingly, women with ASD may not receive an official diagnosis until later in adulthood. Failure to recognize ASD in girls/women at an early age may lead to underdiagnosis or misdiagnosis with other mental health conditions, greatly impacting their mental health, social functioning, and quality of life — compounded by an increased risk of developing comorbid eating disorders, sleep disorders, neurological conditions, and/or psychiatric conditions.2,3
Given the adverse outcomes associated with the under-recognition of ASD symptoms, understanding the presentation of autism symptoms in women can help equip physicians with the knowledge needed to better identify and support women with ASD to improve their quality of life.
What Are the Diagnostic Criteria for Autism?
According to the Diagnostic and Statistical Manual, Fifth Edition (DSM-5), the diagnostic criteria for ASD must include persistent deficits observed in each of the following 3 domains of social communication and interaction:4
Social-emotional reciprocity
Nonverbal communication used for social interactions (ie, lack of facial expressions, lack of nonverbal communication, or abnormalities in eye contact, body language, and use/understanding of gestures)
Relationship development, understanding, and maintenance
In addition to these social and communication deficits, individuals must have a history or current presentation of at least 2 of the 4 types of restricted, repetitive behaviors:4
Stereotyped or repetitive movements, speech, or use of objects
Adherence to inflexible routines, insistence on sameness, or ritualistic patterns of behavior (either verbal or nonverbal)
Restrictive fixations or interests with abnormal intensity or focus
Either hypo- or hyperreactivity to sensory input or atypical interest in sensory aspects of an environment
These 7 diagnostic criteria for ASD are graded on a severity scale by the level of support needed, in which Level 1 requires support, Level 2 requires substantial support, and Level 3 requires very substantial support.4
Gender Differences in Autism Symptom Presentation, Comorbid Conditions
Although the DSM-5 has standardized the diagnostic criteria for ASD, women often elude official diagnosis at an earlier age because their initial symptoms manifest differently, relative to men.
Psychiatry Advisor spoke with Tatiana Rivera Cruz, LICSW, a licensed clinical social worker and therapist, who shared her expertise and insights about these sex- and gender-related differences among individuals with ASD.
She stated, “Boys often [are] diagnosed early on, around 2.5 to 3 years [of age], because the symptoms of autism [are] extremely noticeable and very intense — in particular, extreme, repetitive, behavioral patterns (like hand shaking or repeating certain words) or absence of sensory skills or specific sensory preferences.”
Conversely, she explained that “With girls, the symptoms of autism are muted and not as noticeable. Often times, the symptoms of autism that manifest in women are confused with ADHD, depression, anxiety, or social anxiety.” These misdiagnoses can have a major effect on individuals, as Ms Cruz highlights when discussing her encounter with a patient.
I treated a [woman] who was diagnosed with autism much later in life. The [woman] mentioned that she couldn’t understand what was happening to her because she felt that she couldn’t be social with people or communicate well. She didn’t understand social cues. She didn’t get sarcasm. She didn’t get jokes. She believed it was social anxiety because being around people understandably gave her anxiety since she couldn’t understand them and felt like she didn’t fit in.
When we evaluated her, she met all the criteria for an autism diagnosis — yet for years she received psychotherapy treatments for depression, anxiety, and social anxiety. These treatments weren’t really addressing the underlying problem, rather they were just managing secondary symptoms that developed due to autism.
Aligned with Ms Cruz’s observations, research indicates that boys with ASD exhibit more pronounced restricted, repetitive behaviors compared with girls, promoting earlier recognition and diagnosis by clinicians.1,5 Girls, on the other hand, demonstrate greater social communication skills, prelinguistic and linguistic functioning, autobiographical memory, and cognitive flexibility than boys with ASD.1
Studies also indicate that women with ASD are more likely to be diagnosed with comorbid cardiovascular, endocrine, gastrointestinal, nutrition, and psychiatric disorders, relative to men with ASD.3
Researchers have theorized that differences in sex hormones during the prenatal period affect brain anatomy, function, and gene expression. These sex-based differences in brain development may in turn contribute to the different manifestations that are observed in ASD, like the ability of women with ASD to more frequently and successfully mask or camouflage their symptoms of ASD due to their heightened skills of observation, analysis, imitation, and communication.1
"
[P]hysicians should consider careful ASD screening assessments that account for autism symptoms in women, instead of relying on the more pronounced manifestations that are commonly associated with boys/men.
Societal Factors Influencing Autism Diagnoses in Women
In addition to the differences in symptom presentation and comorbid conditions observed between girls/women and boys/men, delayed diagnosis of ASD in women may be due to societal factors, including clinician bias, parental education, and compensatory behaviors exhibited by girls/women with ASD.
Clinician Bias
According to qualitative research studies, women diagnosed with ASD in adulthood reported that healthcare providers often dismissed their symptoms and lacked awareness of the differences in ASD symptom manifestation among women, leading to delayed diagnoses.6
A systematic review published in 2021 confirmed these self-reported concerns, as investigators found that clinician bias was a barrier to early ASD diagnosis among women. Parents of girls with ASD perceived a hesitancy or reluctance among clinicians to diagnose girls with ASD, and girls were often misdiagnosed with other conditions. The authors noted that part of this reluctance may correspond to the perceived higher incidence of ASD among boys.5
Lack of Parental Education, Resources
Because ASD has long been associated with the stereotypical presentation displayed by boys, many parents believed that ASD was not a relevant diagnosis for girls — thereby dissuading parents from identifying symptoms and seeking a diagnosis earlier in their child’s life. Overall, parents of boys are around 1.46 times more likely to express 1 or more concerns about ASD than parents of girls.5
Ms Cruz commented, “Misinformation is another thing, especially in social media. This may be a cause for delayed diagnosis because people might get the sense that seeking out a diagnosis or an explanation for why they are different from other people isn’t necessary.” Potential misinformation regarding the importance of an early ASD diagnosis and prompt treatment may thwart parents, or even patients themselves, from taking action to seek a diagnosis of ASD.
Compensatory and Camouflaging Behaviors
Given that girls with ASD more frequently use camouflaging techniques to mask social difficulties when interacting with peers, their symptoms may not be as apparent to parents and physicians.5
In a review of the diagnostic implications of autism symptoms in women, study authors broke down social camouflaging into 3 categories: 1) compensation for autistic traits or behaviors, 2) masking one’s own autistic traits via constant monitoring of personal behaviors (such as eye contact, gestures, facial expressions), and 3) assimilating other people’s behaviors and forcing oneself to perform and pretend during social interactions
To further elaborate, Ms Cruz gave the following examples of camouflaging or masking techniques effectively used by girls and women with ASD:
Suppressing behaviors is a masking technique in which individuals with ASD suppress their emotions, expressions, or socially “unacceptable” behaviors to adapt and conform to social settings.
Studying and imitating social behaviors is a camouflaging technique (whether it is done consciously or subconsciously).7 Individuals will observe people during social events and try to imitate these behaviors. Women with autism may try to plan ahead and try to envision how they will react when placed in certain social situations.
Analyzing body language is another masking technique women with ASD use to imitate and fit in with colleagues and peers to feel more comfortable despite their perceived differences.
Scripting conversations may make it difficult to detect ASD in women. Individuals will imagine conversations involving small talk about basic topics to prepare for social interactions. This is frequently paired with rehearsing those conversations beforehand.
Exhibiting excessive accommodations is another masking technique that women with ASD may use. They may try to be more “go-with-the-flow” and not as strict with the requirements that they need to feel comfortable, but this technique becomes very hard to maintain for longer periods of time.
Lastly, helpfulness is a compensatory technique that women with ASD may exhibit. It might pertain to helping other people, but also helpfulness toward oneself (eg, knowing when to take oneself out of an awkward or uncomfortable situation). Women with autism frequently think about these things in advance and use them to adapt to the situation at hand.
Another aspect that may mask ASD in women is the concept that their “special interests” or intense focuses on particular subjects may align more with their neurotypical peers, such as interests in celebrities or animals, like horses. However, the intensity of interest remains atypical.8
Although these camouflaging behaviors may help women with ASD to fit in socially and interact with their neurotypical peers better, these behaviors are superficial coping methods that can promote autistic burnout, constant feelings of exhaustion, a loss of sense of self, and increased anxiety and stress.8
Studies indicate that women with ASD are objectively more adept at these camouflaging techniques than their male counterparts, and this heightened ability among women to mask their symptoms of ASD is associated with superior signal-detection sensitivity.10 Further, the gender-based expectations of girls/women to “be more social” or “act like a girl/woman” may promote a higher degree of censuring ASD symptoms while simultaneously adopting gender-normative social behaviors.9
Consequences of Delayed Diagnosis
A delayed diagnosis of ASD likely results in long-term consequences, given that early interventions during critical developmental stages in childhood can make a major difference in symptom trajectory. Ms Cruz extrapolated on these consequences, stating, “Not catching autism early can lead to increased difficulties with speech and language issues, executive function, self-regulation, and sensory sensitivities if these symptoms of autism are not treated early.”
Women with ASD are more likely to be prescribed psychotropic medications, such as antidepressants, anticonvulsants, and mood stabilizers, while men with ASD have higher odds of being prescribed anticonvulsants, stimulants, or other medications typically used to treat attention-deficit hyperactivity disorder (AHDH) to help manage their symptoms impulsivity, hyperactivity, and distractibility.10
These gender disparities in prescription trends parallel women’s experiences in medicine more generally, and are in line with Ms Cruz’s observation that women often are diagnosed with secondary mental health conditions, such as anxiety or depression, instead of their underlying disorder. These prescription differences reinforce the notion that ASD does in fact manifest differently in women and men.10
Undiagnosed ASD in women may also promote autistic burnout. Although symptoms of autistic burnout differ from case by case, it has been described as “an overwhelming sense of physical exhaustion.”11
Some individuals with autistic burnout may experience uncontrollable emotional outbursts of sadness or anger, intense anxiety, or even suicidal ideation. Autistic burnout can also exacerbate certain symptoms of ASD, including repetitive behaviors, heightened sensitivity to sensory input, or increased difficulty accepting changes to daily routines.11
Evidence suggests that autistic burnout often results as a consequence of camouflaging and mimicking neurotypical behavior, such as small talk, eye contact, and suppressing repetitive behaviors — all of which require significant effort and energy on the part of the individual with ASD.11
Ms Cruz recounted,
Most of the patients that I have seen with autism have said that they have coped with autism for a long time until a point where they can’t do it anymore. That feeling was the driving force behind them eventually seeking help and an official diagnosis. They coped for so many years trying to overcome situations, avoid other situations, manage symptoms, or change the way they saw or did things. At the end, they just can’t do it anymore.
Clinical Challenges Diagnosing Autism in Adults
Diagnosing ASD in adult women may prove challenging to clinicians for several reasons. For example, developmental trajectories and outcomes of social communication vary more during adolescence and adulthood than childhood.12
Additionally, ASD is a neurodevelopmental disorder that by definition manifests in early childhood. If this diagnosis is missed during childhood, it may prove more challenging to diagnose in adults because their parents or other family members may no longer be present to provide reliable childhood medical history or symptom reporting. This is particularly important as patients may not be able to accurately recall or identify autistic traits they may have exhibited at a young age. 12
Given that women with ASD have an increased likelihood to develop comorbid conditions relative to men, clinicians may inadvertently focus more on the management of these conditions and thereby overlook the more subtle symptoms of ASD that are present in women.12
With this in mind, physicians should consider careful ASD screening assessments that account for autism symptoms in women, instead of relying on the more pronounced manifestations that are commonly associated with boys/men. Additionally, women who present with symptoms of ADHD, depression, anxiety, or social anxiety may warrant a full ASD assessment to ensure diagnostic accuracy.
Active efforts are needed to remedy this health disparity. Identifying this “lost generation”12 of adult women with ASD is the first step in validating the struggles that they are enduring, but just might be better at hiding.
Editor’s note: Some responses have been revised for clarity and length.
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Our easy-to-read fact sheets provide clinicians with reliable information to share with patients and their caregivers.
Biomedical therapy for autism spectrum disorder (ASD) is becoming increasingly popular as a complementary treatment option to traditional medication regimes, yet many patients are still unclear about what biomedical therapy entails. Therefore, the following fact sheet provides a helpful overview of biomedical therapy for ASD and answers commonly asked questions.
Autism Spectrum Disorder
Autism spectrum disorder (ASD) is a neurodevelopmental disorder associated with impairment in social communication and interactions as well as the presence of restricted, repetitive behaviors.1 It is influenced by both genetic and environmental factors, though the direct cause is still unknown.2
The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) is considered the gold standard for ASD diagnosis. The diagnostic criteria for ASD are graded on a severity scale by the level of support needed, in which Level 1 requires support, Level 2 requires substantial support, and Level 3 requires very substantial support.2
Common Treatment Options for Autism
Because ASD occurs on a spectrum, treatment options can vary with each patient depending on their unique set of symptoms. There is no curative treatment for ASD, but the management of ASD takes on a multifaceted approach that includes occupational, behavioral, speech, and play therapies. Psychosocial interventions can also help improve specific behaviors, such as language and social engagement.3
Although there are no medications directly indicated for the treatment of ASD specifically, many individuals receive medication for comorbidities associated with their diagnosis. Patients with ASD may take medication for irritability, aggression, hyperactivity, and seizures that may co-present with the condition.2 Some examples of the common medications used to manage these other symptoms and disorders may include:4
Biomedical therapy is a specific treatment approach that considers the underlying biological basis of a condition and targets physiological impairment.5 The goal of biomedical therapy for autism is to optimize physiological factors impacting brain function and development to treat symptoms and improve patient functioning.
Research indicates that ASD is associated with deficits in mitochondrial metabolism and oxidative stress as well as abnormalities in the regulation of the following essential metabolites:6
Folate
Tetrahydrobiopterin
Glutathione
Cholesterol
Carnitine
Branch chain amino acids
Biomedical therapy can be categorized based on the pathophysiological process they target.
Mitochondrial Dysfunction
The mitochondria generate energy for cellular processes. When the mitochondria is impaired, it can lead to developmental delays, muscle weakness, and neurological problems.6 Individuals with ASD who have mitochondrial dysfunction often have more severe behavioral and cognitive deficits, relative to those with typical mitochondrial function. Treatments may include:6
Antioxidants, such as vitamin C and N-acetyl-L-cysteine
L-carnitine
Multivitamins containing vitamin B, vitamin E, co-enzyme Q10
Folate Metabolism
Folate is naturally found in the human body and helps to regulate the absorption of vitamin B. However, individuals with ASD may have genetic modifications in the folate pathway which leads to a decrease in available folate in the brain, known as cerebral folate deficiency. Lack of folate causes symptoms such as fatigue and muscle weakness. Patients with folate irregularity are treated with folinic acid for neurological, behavioral, and cognitive improvements.6
Redox Metabolism
Redox reactions are necessary for many biological functions. Evidence has shown that individuals with ASD may have abnormal redox metabolism which could lead to oxidative damage in areas of the brain responsible for speech, emotion, and social behavior. Several treatments for oxidative stress are available, including:6
Vitamin or mineral supplements containing antioxidants, co-enzyme Q10, and vitamin B
Subcutaneous injections of methylcobalamin (a form of vitamin B12)
Oral folinic acid
Tetrahydrobiopterin supplementation
N-acetyl-L-cysteine
These treatment options can help improve many common ASD symptoms, including hyperactivity, tantrums, sensory-motor skills, irritability, and even sleep and gastrointestinal symptoms.
Tetrahydrobiopterin Metabolism
Tetrahydrobiopterin (BH4) is naturally found in the body and is necessary for multiple important metabolic pathways. Abnormalities in BH4 are prominent in ASD, as the disorder is associated with a lack of oxidative stress needed for BH4 pathways. Treatment for BH4 metabolic dysfunction is primarily the use of sapropterin, a synthetic form of BH4. Sapropretin has been shown to improve cognitive ability, communication, adaptability, verbal expression, and social function in patients with ASD.6
Frequently Asked Patient Questions
At what stage should I consider biomedical therapy for autism?
Because ASD is a lifelong condition that occurs on a spectrum, there is no standard timeline for when a treatment should be started.7 Interventions are tailored to the patient’s specific needs. Although supplements are generally safe and well tolerated, they can have interactions with certain medications. Speak with your healthcare provider when making decisions on treatment options as it is important to keep track of your medications to monitor improvement and prevent adverse medication interactions.
How long does it take to see improvement?
When evaluating treatment success, it is important to consider what symptoms or conditions are being targeted. For example, some patients may be seeking treatment to sleep better or decrease their repetitive behaviors. Tracking progress by logging symptoms and improvements can help you and your provider gain an accurate measure of your treatment response. Improvements may not be seen immediately, especially as certain medications can take time to show measurable effects. Your symptoms may fluctuate over time, so consistent medication adherence is necessary to improve your chances of overall improvement.8
Are there side effects associated with these treatments?
All of the biomedical treatments mentioned throughout this fact sheet are generally considered safe and well-tolerated. However, there are minor side effects for some of these treatments, as detailed below:
Patients taking L-carnitine have expressed slight gastrointestinal issues. Symptoms such as nausea, vomiting, and abdominal cramps are usually experienced when the supplement is taken at night on an empty stomach. To minimize these symptoms, these supplements can be taken after a meal and your time of dosing can be adjusted.6
Some patients taking high-dose folinic acid may experience increased irritability, insomnia, or gastroesophageal reflux when co-administered with other medications, such as antipsychotics.6
Individuals taking N-acetyl-L-cysteine may experience mild side effects such as constipation, fatigue, daytime drowsiness, or increased appetite.6
Not all patients respond to treatment options in the same way. Patients should speak with their providers to discuss their treatment plan and any potential side effects they may experience.
Ketamine clinic popularity has surged in recent years, with a growing number of psychedelic med spas appearing across the United States and globally. However, patients and providers alike have raised regulatory, legal, efficacy, and safety concerns about these clinics.
Ketamine: From Club Drug to Breakthrough Therapy
In the 1970s, ketamine was considered a single-use anesthetic confined to intravenous or intramuscular injection at a surgeon’s office. But it wasn’t long before ketamine emerged beyond the walls of the inpatient setting onto the club scene, where it became a highly popular recreational drug given its dissociative effects. By 1999, this gained the attention of the Drug Enforcement Administration (DEA), which then classified ketamine as a Schedule III controlled substance due to its high risk of dependence, lethal side effects, and potential for abuse.1
Despite its controversial history, interest in ketamine for therapeutic applications began to build around 2015 and in recent years there has been a rapid rise of ketamine clinics, enthusiastic to meet this newfound demand. These clinics offer off-label ketamine for a wide range of conditions, including neuropathic pain, anxiety, Lyme disease, and rheumatoid arthritis.2 As ketamine clinics popped up around the country, the Food and Drug Administration (FDA) approved a nasal spray containing esketamine (the S+ enantiomer) in 2019, called Spravato®, which is approved in conjunction with an oral antidepressant for 1) treatment-resistant depression and 2) patients with major depressive disorder (MDD) presenting with acute suicidal ideation or behavior.3
Although only meant for these specific indications, the approval of Spravato® helped drive ketamine’s perceived legitimacy for chronic disease management. Shortly after Spravato® was approved, the COVID-19 pandemic took over the world and led to a major shift in medical treatment modality as telehealth became both necessary and increasingly popular. As a result, a deregulated ketamine marketplace flourished online under the cover of telemedicine. This expanding market has raised serious red flags among healthcare providers and government agencies, now playing catch-up to protect public safety.4
"
These safeguards don’t apply to the off-label ketamine often provided at ketamine clinics.
To understand if today’s ketamine clinics are serving patients' best interests — or simply taking advantage of a lucrative loophole — we spoke with Lisa M Harding, MD, Board Certified Psychiatrist and Assistant Clinical Professor at Yale School of Medicine, and Griffen Thorne, JD, Partner Attorney at Harris Sliwoski, to learn more.
Do Ketamine Clinics Benefit Patients?
On the surface, ketamine clinics seem to improve access to care for patients in rural areas or places with limited resources. However, Dr Harding is skeptical about the sudden proliferation of ketamine clinics, especially as they don’t take insurance.5 “Access to care has never meant giving substandard care. The folks operating in a space with no formal rules say they are improving access to seem less nefarious,” she explained. “There is no way that one kind of treatment required by the FDA to be delivered in a medical setting is equal to a similar treatment delivered outside of a medical setting just because there are no written rules. The safety challenges are still there.”
While early ketamine clinics relied on intravenous infusion centers with medical supervision, today’s online clinics allow clients to fill generic prescriptions in the form of lozenges that they then take at home with the help of a designated “sitter” — who isn’t necessarily a medical professional.5
“Ketamine is now prescribed online, and in some cases even mailed to patients,” shared Thorne. But this wasn’t always the case. “A federal law, the Ryan Haight Act of 2008, prohibited physicians from prescribing controlled substances without at least 1 in-person evaluation beforehand. But this requirement was suspended during the COVID public health emergency declaration, so now things that weren’t available before are now available online. Some of these laws didn’t immediately change back after the COVID emergency ended,” he said.
Nonetheless, some patients argue that at-home ketamine has been a life-changing treatment and advocate for the continued allowance of telemedicine ketamine treatment. “The DEA is trying to work through a middle ground where telehealth is still available for those who need it,” explained Thorne.
However, many psychiatrists and regulators worry that ketamine treatment outside of a medical setting puts patients at risk.4 Dr Harding explained,
Ketamine was only studied in the short term. No long-term efficacy study has been done on ketamine. Many papers look at retrospective data or comment on models implemented at academic institutions. For example, most patients in treatment with intravenous ketamine get treated once a month with an infusion and are evaluated with a face-to-face physician visit every 3-6 months once they are stable.
However, she shared that esketamine does have a long-term safety study (the Sustain III trial), which enabled the approval of Spravato®. “Patients are treated once a week or once every two weeks, and the data published at the 4-year mark show no new safety signals. Patients in maintenance are assessed by their care team.”
Dr Harding notes in her published work that esketamine is the only antidepressant of its kind to be researched and FDA-approved for depression symptoms in suicidal patients. It works within hours of administration, offering a significant advantage over other antidepressants that can take weeks.6
The FDA only approved Spravato® to be administered in a regulated environment. A Risk Evaluation and Mitigation Strategy (REMS) requires patients to stay in an approved facility for monitoring 2 hours after treatment and data is recorded after every treatment.7 These safeguards don’t apply to the off-label ketamine often provided at ketamine clinics.4
Is It Legal to Prescribe Ketamine?
Ketamine can regularly be administered under the supervision of a licensed doctor in a medical setting, but ketamine prescriptions for at-home use aren’t legal in every state.8 Thorne advised, “Physicians who want to administer ketamine need a DEA registration like any other Schedule III controlled substance.”
Because of the many state, federal, and healthcare regulations that exist, Thorne recommends having a robust compliance plan before operating a ketamine clinic.9 He said the rules change regularly, and what works in some states won’t pass in others. For example, certain states like New York and California have a rule called the Corporate Practice of Medicine (CPOM). This means that businesses like ketamine clinics generally must be owned by a licensed physician. However, CPOM laws vary greatly from state to state, so the requirements in one state may be completely inapplicable to its neighbor. Furthermore, states that don’t require CPOM may have different licensing requirements that need to be followed.
“With ketamine, you deal with healthcare regulations, which are very complicated. And it’s all regulated under state law.” He discussed how this differs from cannabis, which is a Schedule 1 controlled substance. Any time a state legalizes cannabis for recreational use, it still cannot legally be prescribed because it is a Schedule I controlled substance. Doctors can recommend cannabis to patients who can purchase it themselves from a dispensary. But ketamine, which requires a prescription and is subject to greater penalties, is much more heavily regulated in its prescription and administration.
Thorne also noted that just because someone is a doctor and has the legal authority to prescribe ketamine, it doesn’t necessarily mean they’re the best person for the job. “There are all kinds of licensed folks who try to get in on the action, which can lead to some concern, like if you’re dealing with ketamine therapy and you’re actually a podiatrist. Typically, anesthesiologists are involved, especially with infusions. Getting the right people is one of the main issues, especially if you want the drug to be given in a safe, effective, and appropriate way,” said Thorne.
The Future of Ketamine and Other Drugs
Thorne admits that some providers push the limits when it comes to prescribing off-label ketamine. He predicts that more regulation is likely as a result. He also suspects that certain psychedelic drugs are likely to get approved in the next few years, and the DEA will make more rules on how clinics can operate.
“There’s a big interest in all the psychedelics, and there’s a strong chance of approval by 2026, if not sooner, for MDMA and maybe even psilocybin drugs,” Thorne explained. “Oregon has some state allowances for psilocybin, which are soon to come for Colorado. But there isn’t a retail market where you can buy and take it home. It’s all in an office or ‘service center,’ and someone licensed needs to watch you through the course of the drug. If a physician is to participate in that process, it’s not clear to say whether the state boards will approve it.”
Thorne goes on to describe how cost can be a barrier.
It would be a challenge to have insurance cover it. In some ways, these state-level programs are designed to fail because it’s a long time for a licensed facility to be there monitoring. It’s not a sustainable market because only a select group of people can afford it. If it’s going to be so expensive, people will need it to be insured at the federal level, which won’t happen with things like MDMA and psilocybin until the FDA approves them, at the very least. Even with ketamine, which has been used clinically for years, most physicians still only take cash.
According to Dr Harding, the need for more mental health therapies is apparent, but she’s not convinced that ketamine or psychedelics are the answer. “To date, there is no cure for depression,” she shared. “Data tells us that if a patient has more than three bouts of depression, they will be in care for the majority of their life and will always be at risk. Treatment is always individualized, and there must always be informed consent. Patients must understand the risks, benefits, alternatives, and risks of no treatment at all.”
Dr Harding agreed that patients need more options to care for their mental health, but only when supported by solid evidence. “I think there should be further trials to support mood disorders. We don't have good treatments for [post-traumatic stress disorder] or bipolar depression. But we need clinical trials to support us,” she said.
For now, Dr Harding encourages providers and patients to use caution when it comes to ketamine. “For providers, there is a lot of continuing education through the American Psychiatric Association to understand specific state laws… For patients, talk to your current treating providers. They are connected in communities and can connect you with care. Not every treatment is right for you. If an expert tells you that they don't think it will help, they are probably right,” she advised.
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