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PROVIDING EFFECTIVE MENTAL HEALTH TREATMENT IN PRIMARY CARE SETTINGS

By Eric Tepper, M.D.
January 24, 2022
13 min read

Scroll down or click here to view Indications and Important Safety Information

The impact of depression is severe, and the role we have as primary care
physicians (PCPs) to treat these conditions is critical. Major depressive
disorder (MDD) affects more than 19 million American adults.1 The nine core
symptoms include depressed mood, loss of interest or pleasure, change in sleep,
appetite or weight, diminished concentration, feelings of worthlessness,
psychomotor agitation or retardation, suicidal ideation and/or fatigue or loss
of energy. According to DSM-5, to meet diagnostic criteria for MDD five (or
more) symptoms must be present during the same two-week period and represent a
change from previous functioning, and at least one of the symptoms is either (1)
depressed mood or (2) loss of interest or pleasure.2

Challenging to treat forms of depression plague many Americans, making effective
treatment even more crucial for the PCP.

Screening for mental illness is not new to PCPs. Fifty-four percent of PCPs
report that they typically create a behavioral health treatment plan for their
patients, and 43 percent usually or always provide counseling services to their
patients.3

There are a number of antidepressant options available, and for many they work
well. But not all depression is created equal, and some patients are faced with
what we call “challenging to treat depression.” As noted above, about 19.4
million adults are estimated to have major depressive disorder in the United
States and, according to the STAR*D trial, about a third do not respond to two
or more antidepressants of adequate dose and duration and can be considered to
have treatment-resistant depression (TRD).1,4

In cases of challenging to treat depression, PCPs should refer patients to a
mental health specialist, as possible, and as appropriate. There are several
treatment options available for TRD that PCPs and other mental health
professionals should be aware of for their patients:

 * Transcranial magnetic stimulation (TMS) is one option for those who have not
   responded to at least one antidepressant. During a TMS session, an
   electromagnetic coil is placed against a patient’s scalp. Patients then
   undergo a noninvasive procedure that uses magnetic fields to stimulate brain
   neurons. This process may help relieve the symptoms of depression.5 Patients
   are often required to attend daily treatments to a center with a TMS device.
 * Certain oral atypical antipsychotics are shown to be effective when used as
   add-on agents to traditional selective serotonin reuptake inhibitors and
   serotonin and norepinephrine reuptake inhibitors in patients with TRD. These
   medications are used to treat depressive disorders with or without psychotic
   symptoms and can be a helpful approach to managing depression along with
   psychotherapy.6*
 * Electroconvulsive therapy (ECT) is a procedure during which a patient is put
   under general anesthesia, and small currents are passed through the brain in
   a controlled way, triggering a brief seizure to change the brain’s chemistry.
   ECT can reverse symptoms of TRD when other previously tried treatments have
   been unsuccessful.7
 * SPRAVATO® (esketamine) CIII nasal spray in conjunction with an oral
   antidepressant was approved by the FDA in 2019 for adults with TRD and in
   2020 to treat depressive symptoms in adults with MDD with acute suicidal
   ideation or behavior. It is not known if SPRAVATO® is safe and effective for
   use in preventing suicide or in reducing acute suicidal ideation or behavior.
   SPRAVATO® is thought to inhibit the N-methyl-D-aspartate (NMDA) receptor and,
   although the mechanism by which SPRAVATO® exerts its antidepressant effect is
   unknown, it is believed to work differently than currently available oral
   antidepressants.

Spravato also uses a different delivery method – patients self-administer the
medication through a nasal spray, something that had never been done before for
the treatment of TRD.8 SPRAVATO® has Boxed WARNINGS for Sedation, Dissociation
(which may be described as feeling disconnected from yourself, your thoughts,
feelings, space and time), Abuse and Misuse, and Suicidal Thoughts and Behaviors
and is only available through the SPRAVATO® Risk Evaluation and Mitigation
Strategy (REMS) Program. Click here for additional Important Safety Information.

* No Janssen atypical antipsychotic products are indicated for the treatment of
TRD.

More About SPRAVATO®

SPRAVATO® is a helpful option with a different approach for adults with two
subtypes of challenging to treat forms of depression. A PCP can refer a patient
to a certified SPRAVATO® treatment center or choose to treat the patient at
their office by becoming a Risk Evaluation and Mitigation Strategy
(REMS)-certified treatment center. Treatment centers must be REMS-certified to
administer SPRAVATO® because of the risks of serious adverse outcomes such as
sedation and dissociation caused by SPRAVATO® administration, and abuse and
misuse of SPRAVATO®. A REMS is a strategy to manage known or potential risks
associated with a drug and is required by the U.S. Food and Drug Administration
(FDA) to ensure that the benefits of the drug outweigh its risks.

To refer a patient to a SPRAVATO® treatment center, patients must be diagnosed
with TRD or require treatment of depressive symptoms of MDD with suicidal
thoughts or actions. Specifically for TRD, patients may be appropriate for
SPRAVATO® if, after trying at least two or more oral antidepressants, they
continue to experience symptoms of MDD. The medication must be administered at a
REMS-certified treatment center, where patients are monitored for at least two
hours after treatment for side effects including sedation and dissociation, and
blood pressure is also checked intermittently.

SPRAVATO® treatment centers are available across the country, and HCPs can
connect with treatment centers in their region by finding a treatment center
near them. I treat a number of patients with SPRAVATO® and am glad that my
office is a certified treatment center so that I have this as an option in my
medication toolbox.

The Role of PCPs in Mental Health Treatment

By being aware of these different medications and keeping abreast of the
treatment options available for TRD, we can help find interventions that offer
meaningful benefit to patients when it comes to their mental health.  

In an age where more people than ever are being diagnosed with mental illness,
it’s important that we as PCPs not only recognize when a patient with mental
health concerns is sitting in our office but know about treatment options that
may help lead them to lasting recovery.1

Indications and Important Safety Information

Indications:

SPRAVATO® (esketamine) CIII Nasal Spray is indicated, in conjunction with an
oral antidepressant, for the treatment of:

 * Treatment-resistant depression (TRD) in adults.
 * Depressive symptoms in adults with major depressive disorder (MDD) with acute
   suicidal ideation or behavior.

Limitations of Use:

 * The effectiveness of SPRAVATO® in preventing suicide or in reducing suicidal
   ideation or behavior has not been demonstrated. Use of SPRAVATO® does not
   preclude the need for hospitalization if clinically warranted, even if
   patients experience improvement after an initial dose of SPRAVATO®.
 * SPRAVATO® is not approved as an anesthetic agent. The safety and
   effectiveness of SPRAVATO® as an anesthetic agent have not been established.


Important Safety Information

WARNING: SEDATION, DISSOCIATION; ABUSE AND MISUSE; and SUICIDAL
THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning

 * Risk for sedation and dissociation after administration. Monitor patients for
   at least two hours after administration (5.1, 5.2).
 * Potential for abuse and misuse. Consider the risks and benefits of using
   SPRAVATO® prior to use in patients at higher risk of abuse. Monitor for signs
   and symptoms of abuse and misuse (5.3).
 * SPRAVATO® is only available through a restricted program called the SPRAVATO®
   REMS (5.4).
 * Increased risk of suicidal thoughts and behaviors in pediatric and young
   adult patients taking antidepressants. Closely monitor all
   antidepressant-treated patients for clinical worsening and emergence of
   suicidal thoughts and behaviors. SPRAVATO® is not approved for use in
   pediatric patients (5.5).

CONTRAINDICATIONS

SPRAVATO® is contraindicated in patients with:

 * Aneurysmal vascular disease (including thoracic and abdominal aorta,
   intracranial and peripheral arterial vessels) or arteriovenous malformation.
 * History of intracerebral hemorrhage.
 * Hypersensitivity to esketamine, ketamine, or any of the excipients.

WARNINGS AND PRECAUTIONS

Sedation: In clinical trials, 48% to 61% of SPRAVATO®-treated patients developed
sedation and 0.3% to 0.4% of SPRAVATO®-treated patients experienced loss of
consciousness.

Because of the possibility of delayed or prolonged sedation, patients must be
monitored by a healthcare provider for at least 2 hours at each treatment
session, followed by an assessment to determine when the patient is considered
clinically stable and ready to leave the healthcare setting.

Closely monitor for sedation with concomitant use of SPRAVATO® with CNS
depressants (e.g., benzodiazepines, opioids, alcohol).

Dissociation: The most common psychological effects of SPRAVATO® were
dissociative or perceptual changes (including distortion of time, space and
illusions), derealization and depersonalization (61% to 84% of SPRAVATO®-treated
patients developed dissociative or perceptual changes). Given its potential to
induce dissociative effects, carefully assess patients with psychosis before
administering SPRAVATO®; treatment should be initiated only if the benefit
outweighs the risk.

Because of the risks of dissociation, patients must be monitored by a healthcare
provider for at least 2 hours at each treatment session, followed by an
assessment to determine when the patient is considered clinically stable and
ready to leave the healthcare setting.

Abuse and Misuse: SPRAVATO® contains esketamine, a Schedule III controlled
substance (CIII), and may be subject to abuse and diversion. Assess each
patient’s risk for abuse or misuse prior to prescribing and monitor all patients
for the development of these behaviors or conditions, including drug-seeking
behavior, while on therapy. Individuals with a history of drug abuse or
dependence are at greater risk; therefore, use careful consideration prior to
treatment of individuals with a history of substance use disorder and monitor
for signs of abuse or dependence.

SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS): SPRAVATO® is available
only through a restricted program called the SPRAVATO® REMS because of the risks
of serious adverse outcomes from sedation, dissociation, and abuse and misuse.

Important requirements of the SPRAVATO® REMS include the following:

 * Healthcare settings must be certified in the program and ensure that
   SPRAVATO® is:
   * Only dispensed and administered in healthcare settings.
   * Patients treated in outpatient settings (e.g., medical offices and clinics)
     must be enrolled in the program.
   * Administered by patients under the direct observation of a healthcare
     provider and that patients are monitored by a healthcare provider for at
     least 2 hours after administration of SPRAVATO®.
 * Pharmacies must be certified in the REMS and must only dispense SPRAVATO® to
   healthcare settings that are certified in the program.

Further information, including a list of certified pharmacies, is available at
www.SPRAVATOrems.com or 1-855-382-6022.

Suicidal Thoughts and Behaviors in Adolescents and Young Adults: In pooled
analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other
antidepressant classes) that included adult and pediatric patients, the
incidence of suicidal thoughts and behaviors in patients age 24 years and
younger was greater than in placebo-treated patients. SPRAVATO® is not approved
in pediatric (<18 years of age) patients.

There was considerable variation in risk of suicidal thoughts and behaviors
among drugs, but there was an increased risk identified in young patients for
most drugs studied.

Monitor all antidepressant-treated patients for clinical worsening and emergence
of suicidal thoughts and behaviors, especially during the initial few months of
drug therapy and at times of dosage changes. Counsel family members or
caregivers of patients to monitor for changes in behavior and to alert the
healthcare provider. Consider changing the therapeutic regimen, including
possibly discontinuing SPRAVATO® and/or the concomitant oral antidepressant, in
patients whose depression is persistently worse, or who are experiencing
emergent suicidal thoughts or behaviors.

Increase in Blood Pressure: SPRAVATO® causes increases in systolic and/or
diastolic blood pressure (BP) at all recommended doses. Increases in BP peak
approximately 40 minutes after SPRAVATO® administration and last approximately 4
hours.

Approximately 8% to 19% of SPRAVATO®-treated patients experienced an increase of
more than 40 mmHg in systolic BP and/or 25 mmHg in diastolic BP in the first 1.5
hours after administration at least once during the first 4 weeks of treatment.
A substantial increase in blood pressure could occur after any dose administered
even if smaller blood pressure effects were observed with previous
administrations. SPRAVATO® is contraindicated in patients for whom an increase
in BP or intracranial pressure poses a serious risk (e.g., aneurysmal vascular
disease, arteriovenous malformation, history of intracerebral hemorrhage).
Before prescribing SPRAVATO®, patients with other cardiovascular and
cerebrovascular conditions should be carefully assessed to determine whether the
potential benefits of SPRAVATO® outweigh its risk.

Assess BP prior to administration of SPRAVATO®. In patients whose BP is elevated
prior to SPRAVATO® administration (as a general guide: >140/90 mmHg), a decision
to delay SPRAVATO® therapy should take into account the balance of benefit and
risk in individual patients.

BP should be monitored for at least 2 hours after SPRAVATO® administration.
Measure blood pressure around 40 minutes post-dose and subsequently as
clinically warranted until values decline. If BP remains high, promptly seek
assistance from practitioners experienced in BP management. Refer patients
experiencing symptoms of a hypertensive crisis (e.g., chest pain, shortness of
breath) or hypertensive encephalopathy (e.g., sudden severe headache, visual
disturbances, seizures, diminished consciousness, or focal neurological
deficits) immediately for emergency care.

Closely monitor blood pressure with concomitant use of SPRAVATO® with
psychostimulants (e.g., amphetamines, methylphenidate, modafinil, armodafinil)
or monoamine oxidase inhibitors (MAOIs).

In patients with a history of hypertensive encephalopathy, more intensive
monitoring, including more frequent blood pressure and symptom assessment, is
warranted because these patients are at increased risk for developing
encephalopathy with even small increases in blood pressure.

Cognitive Impairment

Short-Term Cognitive Impairment: In a study in healthy volunteers, a single dose
of SPRAVATO® caused cognitive performance decline 40 minutes post-dose. Compared
to placebo-treated subjects, SPRAVATO®-treated subjects required a greater
effort to complete the cognitive tests at 40 minutes post-dose. Cognitive
performance and mental effort were comparable between SPRAVATO® and placebo at 2
hours post-dose. Sleepiness was comparable after 4 hours post dose.

Long-Term Cognitive Impairment: Long-term cognitive and memory impairment have
been reported with repeated ketamine misuse or abuse. No adverse effects of
SPRAVATO® nasal spray on cognitive functioning were observed in a one-year
open-label safety study; however, the long-term cognitive effects of SPRAVATO®
have not been evaluated beyond one year.

Impaired Ability to Drive and Operate Machinery: Before SPRAVATO®
administration, instruct patients not to engage in potentially hazardous
activities requiring complete mental alertness and motor coordination, such as
driving a motor vehicle or operating machinery, until the next day following a
restful sleep. Patients will need to arrange transportation home following
treatment with SPRAVATO®.

Ulcerative or Interstitial Cystitis: Cases of ulcerative or interstitial
cystitis have been reported in individuals with long-term off-label use or
misuse/abuse of ketamine. In clinical studies with SPRAVATO® nasal spray, there
was a higher rate of lower urinary tract symptoms (pollakiuria, dysuria,
micturition urgency, nocturia, and cystitis) in SPRAVATO®-treated patients than
in placebo-treated patients. No cases of esketamine-related interstitial
cystitis were observed in any of the studies, which involved treatment for up to
a year.

Monitor for urinary tract and bladder symptoms during the course of treatment
with SPRAVATO® and refer to an appropriate healthcare provider as clinically
warranted.

PREGNANCY, EMBRYO-FETAL TOXICITY, AND LACTATION

SPRAVATO® is not recommended during pregnancy. SPRAVATO® may cause fetal harm
when administered to pregnant women. Advise pregnant women of the potential risk
to an infant exposed to SPRAVATO® in utero. Advise women of reproductive
potential to consider pregnancy planning and prevention.

There are risks to the mother associated with untreated depression in pregnancy.
If a woman becomes pregnant while being treated with SPRAVATO®, treatment with
SPRAVATO® should be discontinued and the patient should be counseled about the
potential risk to the fetus.

Pregnancy Exposure Registry: There is a pregnancy exposure registry that
monitors pregnancy outcomes in women exposed to antidepressants, including
SPRAVATO®, during pregnancy. Healthcare providers are encouraged to register
patients by contacting the National Pregnancy Registry for Antidepressants at
1-844-405-6185 or online at https://womensmentalhealth.org/
clinical-and-research-programs/pregnancyregistry/antidepressants/.

SPRAVATO® is present in human milk. Because of the potential for neurotoxicity,
advise patients that breastfeeding is not recommended during treatment with
SPRAVATO®.

SELECT USE IN SPECIFIC POPULATIONS

Geriatric Use: No overall differences in the safety profile were observed
between patients 65 years of age and older and patients younger than 65 years of
age. At the end of a 4-week, randomized, double-blind study, there was no
statistically significant difference between groups on the primary efficacy
endpoint.

Hepatic Impairment: SPRAVATO®-treated patients with moderate hepatic impairment
may need to be monitored for adverse reactions for a longer period of time.

SPRAVATO® has not been studied in patients with severe hepatic impairment
(Child-Pugh class C). Use in this population is not recommended.

ADVERSE REACTIONS

The most common adverse reactions with SPRAVATO® plus oral antidepressant
(incidence ≥5% and at least twice that of placebo nasal spray plus oral
antidepressant) were:

TRD: dissociation, dizziness, nausea, sedation, vertigo, hypoesthesia, anxiety,
lethargy, blood pressure increased, vomiting, and feeling drunk.

Treatment of depressive symptoms in adults with MDD with acute suicidal ideation
or behavior: dissociation, dizziness, sedation, blood pressure increased,
hypoesthesia, vomiting, euphoric mood, and vertigo.

Please see full Prescribing Information, including Boxed WARNINGS, and
Medication Guide for SPRAVATO®.

REFERENCES

 1. National Institute of Mental Health. Major Depression. Accessed November 10,
    2021. https://www.nimh.nih.gov/health/statistics/major-depression
 2. American Psychiatric Association. Diagnostic and Statistical Manual of
    Mental Disorders: DSM-5. Washington, DC: American Psychiatric Association;
    2013
 3. School of Public Health Behavioral Health Workforce Research Center.
    Behavioral Health Service Provision by Primary Care Physicians. Accessed
    October 5, 2021.
    https://behavioralhealthworkforce.org/wp-content/uploads/2019/12/Y4-P10-BH-Capacityof-PC-Phys_Full.pdf
 4. Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in
    depressed outpatients requiring one of several treatment steps: a STAR*D
    report. Am J Psychiatry. 2006;163(11):1905-1917.
 5. Mayo Clinic. Transcranial magnetic stimulation. Accessed October 5, 2021.
    https://www.mayoclinic.org/tests-procedures/transcranial-magnetic-stimulation/about/pac-20384625.
 6. Wang P and Tianmei S. Shanghai Arch Psychiatry. 2013;25(3):134-140.
 7. American Psychiatric Association. What is electroconvulsive therapy (ECT)?
    Accessed October 5, 2021. https://www.psychiatry.org/patients-families/ect.
 8. Janssen Pharmaceuticals, Inc. SPRAVATO®. Accessed October 5, 2021.
    https://www.spravato.com/.

HEALIO DISCLAIMER
The content presented here was sponsored by Janssen Pharmaceuticals. The news
and editorial staff of Healio had no role in the creation of this digital
advertorial.

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