KETAMINE INFORMED CONSENT
This is an informed consent document to provide written information about the above named treatment risks, benefits and alternatives. It is important that you understand the information provided to you prior to proceeding with this treatment, please ask your healthcare professional any and all questions prior to signing this informed consent.
Purpose of Ketamine Treatment and General Information:
Depression remains a leading cause of disability worldwide (WHO, 2017) affecting nearly 300 million individuals globally (Charlson et al., 2019; Herrman et al., 2019). Depression is also a major contributor to the global burden of disease, with high rates of career burden and rising socioeconomic and healthcare costs.
The majority of patients with depression are currently treated with monoamine-based antidepressants. However, these drugs have low success rates in long-term treatment, with meta-analysis of RCT trials showing that antidepressants are only effective for 42-51% of patients with major depressive disorder (MDD). Furthermore, approximately one-third of patients fail to achieve meaningful recovery (Corriger and Pickering, 2019). Although some will respond to a subsequent trial of a different medication, the likelihood of a patient benefiting from a medication decreases with the number of medications they have tried before (ref).
Treatment-Resistant Depression (TRD) has been defined as a depressive illness of at least moderate severity that has not responded to at least two trials of appropriate medication (Al-Harbi, 2012). Up to a third of depression patients are thought to fall in this category, with remission rates reportedly being less than 15% among patients with two prior conventional treatment or augmentation failures. Consequently, there is an urgent need for effective treatments for treatment-resistant depression (TRD) (Shah, 2016).
The treatment landscape for TRD has changed with the discovery in 2000 that a single sub-anesthetic dose of intravenous ketamine have rapid and potent effect in reducing depressive symptoms in TRD. This has been a successful repurposing of a drug that was first introduced to the medical community as a surgical anesthetic more than 50 years ago and a paradigm shift for depression research and treatment. Since then, multiple RCT as well as meta-analysis have demonstrated the efficacy of ketamine in the treatment of TRD as well as of other disorders, such as post-traumatic stress disorder (PTSD).
Ketamine is a Schedule III medication that has been used safely as an anesthetic and analgesic since it was FDA-approved in 1970 for that purpose. It is increasingly prescribed “off-label” for treatment of anxiety, depression, post-traumatic stress disorder (PTSD), chronic pain, and other indications. Off-label prescribing is both legal and common. About one in five prescriptions are written for an off-label use.
Ketamine is classified as a dissociative anesthetic that produces a sense of disconnection from one’s ordinary reality and usual self. At the dosage level administered to you, you will likely experience mild anesthetic, anxiolytic, antidepressant and psychedelic effects. Relaxation from ordinary concerns and usual states of mind, while maintaining conscious awareness of the flow of mind under the influence of ketamine is characteristic. This can lead to a disruption of negative feelings and obsessional preoccupations. The dissociative effects of ketamine are short-lived, and most people return to their ordinary level of awareness and state of mind within 45-90 minutes following administration.
Ketamine has an extensive historical safety record and has been used at much higher doses for surgical anesthesia and procedural sedation. As with any medication, it is not without risks (discussed in more detail below), and these must be kept in mind when determining whether ketamine is the right treatment for you.
The aim of this protocol is to establish a treatment pathway, set of procedures and minimum standards for the safe delivery of ketamine for patients with TRD and other mental health disorders.
I understand the treatment goal is to alleviate subjective symptoms and that there is no implied or stated guarantee of success or effectiveness of any treatment.
Ketamine has been shown to alleviate symptoms across a variety of mental health issues, as listed above. For people who have responded to ketamine in clinical trials, the initial antidepressant effects are often detectable within hours of administration, with peak antidepressant effects occurring approximately 24 - 48 hours after session, on average. The duration of ketamine’s antidepressant effect varies from person to person and can range from a few days to two weeks or longer following a single treatment.
Prior to your initial treatment, you and your Better U affiliated clinician will determine the initial treatment regimen that has the greatest likelihood of achieving your treatment goals.
Infusions of Lanicemine, Nitrous Oxide, Mamantine, among others.
Possible Risks and Side Effects:
The possible side effects and risks of Ketamine Therapy include, but are not limited to:
Ketamine may cause adverse effects including, but not limited to: altered sense of time, blurred vision, diminished ability to see/hear/feel, dizziness, elevated blood pressure and heart rate, elevated intraocular or intracranial pressure, excitability, loss of appetite, loss of balance or unsteady gait, mental confusion, nausea or (vomiting is rare) nystagmus (rapid eye movements), restlessness, slurred speech, synesthesia (a mingling of the senses), flashbacks, hallucinations and disorientation. When these occur, they are time-limited and tend to resolve spontaneously as the acute effects of the ketamine wear off.
Rare side effects include arrythmia, low blood pressure, cystitis of the bladder (typically only seen in recreational abuse at high doses frequently over an extended period of time) and an allergic reaction.
Long-term ketamine usage is not recommended. Typically people will start with 4-8 sessions per month for the first 2-3 months. Then moving to once per week or once or twice per month as "maintenance" sessions. We also recommend taking 1 month off after 4 months to properly gauge lasting benefits.
This list is not meant to be inclusive of all possible risks associated with Ketamine Therapy, as there are both known and unknown side effects associated with any medication or procedure.
I understand that other controlled substances, certain herbal products, medications, and supplements may result in reduced efficacy of treatment and/or additional side effects when interacting with Ketamine.
I understand that Better U, LLC is not a medical facility, nor does it provide medical diagnostics or medical care. If I feel I need medical attention and/or am concerned about a new or ongoing medical condition, I agree to seek medical attention and care at a qualified medical facility. The clinicians that we work with are a part of Better U Medical Group, P.C. and can provide additional guidance for your ketamine treatments.
I have read and agree to the aforementioned medical care statement.
Your privacy is a priority and all treatment records will be kept confidential. They will be maintained with the same precautions as ordinary medical records. If you would like to provide other individuals or organizations with access to your records, contact us for a release form.
By electronically signing this document, I confirm that:
I have fully read and understand this agreement. I will comply with all stipulations included in this agreement and use my medication only as directed by my assigned Better U affiliated clinician. If I break this agreement, I will be disqualified from future services with Better U.