Spravato Informed Consent

Consent for Treatment Using SPRAVATO® (Esketamine)

JOURNEY CLINICAL PSYCHIATRY PC

JOURNEY CLINICAL PSYCHIATRY CA PC

JOURNEY CLINICAL PSYCHIATRY TX PC

Your Journey provider will discuss with you treatment of your current condition with SPRAVATO®, including enrollment, monitoring, risks of sedation, dissociation, respiratory depression, and other changes in vital signs, and the need to have arrangements to safely leave the healthcare setting and not engage in potentially hazardous activities. Your Journey provider will present information in language that you can understand. . By the end of the discussion, you will have all the information you need to make an informed decision as to which medication is right for you.

You acknowledge that patients will have varying success in treatment depending on the severity of their complaints and not everyone is a good candidate for SPRAVATO®. You understand that, although your Journey provider may conclude that SPRAVATO® may help you, there are no guarantees that your condition will improve from SPRAVATO®.

You understand that SPRAVATO® can have significant side effects which your Journey provider has discussed with you. You understand that SPRAVATO® could have effects on your brain, body, consciousness, emotions, actions, sleep, memory, judgment, coordination, stamina, and sexuality. You confirm that you will review information about any given treatment and will ask your provider any questions or clarify any concerns. You also confirm that you have been given an opportunity to decline treatment using SPRAVATO®.

You hereby waive any and all claims against Journey or your treatment provider, including any additional members, directors, officers, employees, agents, or related parties of Journey or your provider, for the use of such treatments in your psychiatric care. This agreement will also be directed to your heirs and assigns. This agreement, waiver, and release pertains to SPRAVATO® that is prescribed as part of your treatment.

Overview

SPRAVATO® (esketamine) is an FDA-approved prescription nasal spray indicated for treatment-resistant depression (TRD) in adults, with or without an oral antidepressant, and for depressive symptoms in adults with major depressive disorder (MDD) experiencing acute suicidal ideation or behavior, used in combination with an oral antidepressant. Unlike compounded ketamine, which is prescribed off-label for psychiatric conditions, SPRAVATO® is FDA-approved for these specific indications and is administered exclusively in a certified healthcare setting under clinical supervision.

How SPRAVATO® Works

Esketamine is the S-enantiomer of ketamine and is chemically related to the ketamine described above. It works by targeting NMDA receptors in the brain, blocking their activity and resulting in increased glutamate, the primary excitatory neurotransmitter. This action helps to restore connections between brain cells, potentially improving mood symptoms. The mechanism is similar to that of ketamine but SPRAVATO® is delivered via a proprietary nasal spray device rather than by sublingual, intramuscular, or intravenous routes.

REMS Program

SPRAVATO® is subject to a Risk Evaluation and Mitigation Strategy (REMS) program required by the FDA due to risks of serious adverse outcomes including sedation and dissociation. As part of the REMS program: (1) SPRAVATO® is dispensed only to certified healthcare settings – it is never dispensed directly to patients and cannot be taken home; (2) You must self-administer SPRAVATO® under the direct observation of a healthcare provider; (3) You must be monitored for a minimum of 2 hours after each dose at the clinic before being released.

Eligibility for Treatment Using SPRAVATO®

To be eligible for treatment using SPRAVATO®, you must first undertake the following steps:∙ Undergo a SPRAVATO® consultation, where your Journey provider will review your medical history, treatment goals, and insurance to determine if SPRAVATO® is right for you; and∙ Assist you with enrollment in the SPRAVATO® REMS Program.Treatment Process

Before each session:

Avoid eating for at least 2 hours before and drinking liquids for at least 30 minutes prior to your treatment.Do not take stimulant medications or medications/substances that can cause respiratory depression prior to your treatment.Do not use sedating medications (benzodiazepines, opioids, etc.) or alcohol for 24 hours before and 24 hours after treatment unless otherwise instructed by your provider.If you have obstructive sleep apnea, bring your CPAP device to your treatment.

Administration:

SPRAVATO® is self-administered as a nasal spray under the direct supervision of a licensed healthcare provider in a certified healthcare setting. You will never be given the device to self-administer at home.Treatment Frequency:Induction phase (Weeks 1–4): Two in-office treatments per weekOptimization phase (Weeks 5–9): Weekly in-office treatmentsMaintenance phase (Week 10+): Frequency determined by you and your prescribing clinician based on response, typically weekly or bi-weekly with the goal of spacing treatments out while keeping your depression in remission.

Monitoring:You must be monitored in the clinic for a minimum of 2 hours after self-administration. Vital signs will be checked before dosing and at 40 minutes, 1 hour, and 2 hours post-dose. If your blood pressure is above 140/90 on the day of treatment, your provider may decide to delay treatment or administer a blood pressure medication. If you are currently prescribed blood pressure medications, bring them to your appointment.Potential Benefits• May reduce depressive symptoms when oral antidepressants have not been effective. • May provide rapid onset of antidepressant effects.• May reduce suicidal thoughts in some patients. Note: SPRAVATO® has not been proven to prevent suicidal acts or behaviors.Potential Risks and Side EffectsCommon side effects include:• Dissociation (feeling detached from yourself or surroundings)• Dizziness, vertigo, spinning sensation• Nausea and vomiting• Temporary bad taste• Hypoesthesia (decreased sensation in extremities)• Anxiety, panic attacks• Fatigue, sedation, or lethargy• Blood pressure increases• Feeling intoxicated

Serious risks include:

Respiratory Depression/Difficulty Breathing: High risk when combined with other medications or substances that can cause central nervous system depression.Loss of ConsciousnessPotential for Abuse and Misuse: Esketamine is a Schedule III controlled substance; administration is limited to certified healthcare settings.Suicidal Thoughts and Behaviors: Possible increase in suicidal thoughts, especially in patients under 25; close monitoring is required.Cognitive Impairment: Temporary effects on attention, judgment, thinking, reaction speed, and motor skills.Bladder Problems: Potential long-term use risks including cystitis and bladder pain.Contraindications

Do not use SPRAVATO® if you have:

A history of aneurysmal vascular disease, arteriovenous malformation, or intracerebral hemorrhage

Allergy or hypersensitivity to esketamine, ketamine, or any SPRAVATO® ingredients

Current pregnancy or breastfeedingUncontrolled cardiovascular or respiratory disease, or uncontrolled high blood pressure

Severe liver disease

Drug Interactions and Precautions

Inform your healthcare provider if you:

• Take any medications, including over-the-counter drugs and supplements

• Have a history of substance misuse and/or daily alcohol or drug use• Have high blood pressure or heart problems

• Have liver problems

• Are planning to become pregnant

• Have a history of psychosis or mania

• Use recreational drugs and/or alcoholAftercare

Do not drive, operate heavy machinery, or care for young children on your own until you have had a full night’s rest after your treatment (minimum 12 hours). If you choose to drive after your treatment, the clinic is ethically required to call 911 for your safety and the safety of others.

You are responsible for arranging transportation home after each session.

Avoid alcohol and/or recreational drugs and central nervous system depressant medications on the day of your treatment and for 24 hours after.We do not recommend engaging in occupational activities for 12 hours after SPRAVATO® treatment.

You will be offered escort assistance for restroom breaks and to the elevator/stairs after your treatment if needed. You are required to remain in the office until side effects have resolved and a minimum of 2 hours have elapsed.

If you experience any acute or emergent symptoms after treatment (chest pain, mental status changes, shortness of breath, suicidal ideation, etc.), immediately call 911 or go to the nearest emergency room.

Call our office during business hours with any medication questions or mild side effects.

Treatment Response and DurationImprovement may occur within days or weeks; full benefits may take several weeks to months. Duration of treatment is individualized based on response; regular assessments will guide therapy continuation. Scientists do not yet know the long-term risks of this treatment beyond 6 years. After one and three-year observation periods in clinical trials, no long-term cognitive impairment was observed.

Alternative Treatments for Treatment-Resistant Depression

• Other antidepressant medications or mood stabilizer medications

• Psychotherapy

• Ketamine (treatments supervised in a medical office)

• Electroconvulsive therapy (ECT)

• Transcranial magnetic stimulation (TMS)

• Vagus nerve stimulation (VNS)

• Clinical trials investigating new treatments for depressionPatient

Acknowledgement and Consent for SPRAVATO®

By signing this consent, I acknowledge and agree to the following:I understand that I am being offered SPRAVATO® for my treatment-resistant depression and that I have been informed about alternative treatment options.If I am a reproductive-age biological female, I agree to use contraception and to inform my provider immediately if I think I may be pregnant. I understand that SPRAVATO® may cause fetal harm.I understand that scientists do not yet know the long-term risks of this treatment beyond 6 years.I have been given the package insert and/or SPRAVATO® Medication Guide upon my request and been given the opportunity at each session to ask my clinician any questions.I have been instructed not to use any sedating medications (benzodiazepines, opioids, etc.), psychostimulants (due to increased blood pressure risk), or alcohol for 24 hours before and 24 hours after treatment unless otherwise instructed by my provider.

I agree to limit alcohol use during the course of treatment and will not use any illicit drugs.

I understand that if my blood pressure is above 140/90 on the day of treatment, my provider may delay treatment or administer a blood pressure medication, and I will bring any prescribed blood pressure medications to my appointment.

I do not have any known medical contraindications to this treatment such as pregnancy, aneurysmal vascular disease, arteriovenous malformation, history of stroke/intracerebral hemorrhage, severe hepatic impairment, allergy to esketamine or ketamine, history of heart attack, or severe respiratory disease.

I agree not to drive, operate heavy machinery, or care for young children on my own until I get a full night’s rest after receiving SPRAVATO® treatment, and will secure safe transportation home after each session.

I am required to remain in the office until side effects from SPRAVATO® have resolved and a minimum of 2 hours have elapsed. I have been offered escort assistance for restroom breaks and to the elevator/stairs after treatment if needed.

I agree that if I experience any acute or emergent symptoms after treatment (chest pain, mental status changes, shortness of breath, suicidal ideation, etc.), I will immediately call 911 or go to the nearest emergency room.

I agree to call my medical provider’s office during business hours with any medication questions or mild side effects.