WHAT SHOULD I EXPECT IF I CHOOSE TO RECEIVE KETAMINE FOR DEPRESSION?
Your PAKC psychiatrist, an outside mental health professional, or perhaps your primary care physician (PCP), might refer you to APSKC for a Ketamine Screening Assessment. You will be screened by a psychiatrist who is familiar with our requirements for receiving ketamine for the treatment of depression.
These requirements are called inclusion criteria (things about your current or past psychiatric and medical histories that are required before you may be treated) and exclusion criteria (things about your psychiatric or medical histories that would prevent you being treated). These criteria have been determined by our Ketamine Treatment Team and you may review these in the Appendix.
At the screening visit you will be asked questions to determine whether you meet the required inclusion and exclusion criteria. Your responsibility is to honestly and fully answer these questions. Depending on the details of your history, the psychiatrist might use discretionary clinical judgment in determining whether it is appropriate for you to receive ketamine for depression. In other words, you might not strictly meet inclusion and exclusion criteria, but still be felt an appropriate candidate for receiving ketamine for depression. You will undergo a psychiatric evaluation with an emphasis on psychiatric diagnosis and your past treatment history with antidepressants, including response and side-effect issues. The psychiatric evaluation will likely require 60-90 minutes. One of the requirements for undergoing ketamine treatment by PAKC is a diagnosis of Major Depressive Disorder (MDD) as described by the Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM 5), or a diagnosis felt to be a clinical variant of MDD. In certain cases, the treatment of some forms of Bipolar Depression might also be appropriate in our ketamine clinic. There are forms of depression other than MDD and other ways of diagnosing depression that the psychiatrist who referred you for treatment might have used to diagnose you with depression. So even if the psychiatric evaluation for ketamine treatment does not show that you have a diagnosis of MDD, it does not mean that you are not depressed, but simply have a form of depression for which we do not currently feel ketamine treatment is appropriate. This ketamine-screening psychiatric evaluation will also help us determine whether you might have other psychiatric diagnoses or conditions that would exclude you from receiving ketamine. These might include certain personality characteristics that might make ketamine treatment inappropriate for you.
If the psychiatrist and you feel that ketamine is an appropriate treatment, then you will be given an Informed Consent Document to review and ask the psychiatrist any questions. The informed consent document will give you information necessary for you to make the decision of whether you want to proceed with treatments.
- Patient Health Questionaire-9 (PHQ-9). The PHQ-9 is a brief 1-2 minute, self-administered test used to measure the severity of depression and response to treatment.
- Montgomery-Asbury Depression Rating Scale (MADRS). The MADRS is a well-established test for helping measure the degree of depression that you have and only takes a few minutes of questions from the psychiatrist.
- Clinical Global Impressions Scale (CGI). The CGI is brief 1-2 minute test with questions to assess the severity of depressive symptoms and progress during treatment
- Columbia Suicide Severity Rating Scale (CSSRS). The CSSRS is a well-established way of helping the psychiatrist determine the severity of any suicidal thinking that you might be experiencing.
Sometimes, these tests provide results that are difficult to interpret. Additional testing, including psychological, laboratory or medical tests, might be required to finally determine whether you meet the inclusion/exclusion criteria for receiving ketamine. These tests will be discussed with you if they are needed.
If you meet the psychiatric inclusion/exclusion criteria, then you will be asked to complete medical history information forms for the anesthesiologists who will provide you with the ketamine infusions. These forms will provide screening information to assess whether-or-not it is appropriate for you to receive a ketamine infusion in an office-based environment. Patients with certain medical disorders should have their care delivered in a hospital setting or might not be candidates for ketamine therapy all together. The anesthesiologist will review the medical information you provide, and if it is felt you are an acceptable candidate for office-based ketamine infusions, you will be scheduled for your first infusion appointment. At the initial infusion appointment, the anesthesiologist will discuss potential anesthesia risks and perform a basic physical exam. If the examination by the anesthesiologist is passed, then you will receive your first ketamine infusion.
You will be told to take a low dose of clonidine (0.1mg) by mouth on the morning and evening of the day before your ketamine treatment. Clonidine is approved by the FDA for treatment of high blood pressure, Attention Deficit Disorder, neuropathic pain, seizure disorder, mood disorder and migraine headache. However, clonidine has also been shown to reduce the chance of developing hallucinations or other uncomfortable feelings when a person is given ketamine and you will be given clonidine for this purpose. You will also be given clonidine 0.1mg on the morning of your ketamine treatment and on the evening following your ketamine treatment. Depending on your medical history and your required medications, clonidine might not be given.
It will be important that you not drink any liquids or eat any food before receiving your treatments. Specific information regarding restrictions on fluids and food will be given in advance of your treatments. Your treating psychiatrist will give you instructions on what to do about any morning medications you normally take. You will receive instructions about your arrival time and must bring a responsible adult with you for transportation back home after the treatment. You will not be able to drive yourself since you might experience some drowsiness and dizziness for a few hours after each treatment. Once you are checked in by a staff member, you will meet with the psychiatrist who will discuss your current symptoms and administer the PHQ-9, MADRS, CGI and CSSRS. You will then meet with the anesthesiologist prior to treatment. An intravenous (IV) line will be started for administering ketamine. During ketamine treatment for depression, you will be given intravenous (IV) ketamine once-a-week for 6 weeks (this is called the acute treatment period). Your treating psychiatrist might also recommend periodic additional ketamine treatments, called maintenance treatments, at various intervals (for example, once every two to four weeks).
The decision about maintenance treatments will depend on several things, including your response to ketamine during the acute treatment period, your past history of antidepressant medication response, or symptoms that suggest you are high risk for depressive symptoms worsening, During each treatment, a sub-anesthetic dose of ketamine will be given slowly over a 40 minute period by an anesthesiologist trained and experienced in the administration of ketamine. The amount of ketamine given will depend on your weight. The amount given is calculated by multiplying your weight in kilograms (Kg) time 0.5milligrams (mg) per kilogram. For example, a 155 lb (70.5 Kg) will be given a total of 35.25 mg. The dose of ketamine given for treating depression is much lower than that required when it is used as an anesthetic, where 3-7 mg/Kg might be required instead of the 0.5mg/Kg that you will receive. The psychiatrist and/or anesthesiologist might decide that changes in the ketamine dose, duration of infusions and frequency of treatments are indicated during the course of treatments. During the treatment, your heart rate, breathing, blood pressure, oxygen content in your bloodstream, and electrocardiogram (ECG) are monitored, and you are observed for any evidence of confusion, agitation, or hallucinations.
After the completion of the ketamine infusion, you will be monitored by staff during a recovery period that will usually last 20-30 mins., but could last as long as 90 mins. Ketamine is known to cause side-effects such as confusion and hallucinations. While these are temporary, they can be quite uncomfortable. Medication might be required to control more severe symptoms. These medications will be chosen by the psychiatrist and/or anesthesiologist and, depending on the nature of the symptoms might include antipsychotics (e.g., Haldol, Zyprexa or Geodon), benzodiazepines (e.g., Versed or Ativan), or clonidine (which is used as a medication to control high blood pressure, but may also control side-effects such as hallucinations). If serious or life-threatening medical events occur, then you will be transported to the nearest hospital emergency department.
At the end of the recovery period you will be asked questions by the psychiatrist and the PHQ-9, MADRS, CGI and CSSRS tests will be given. You (and the person transporting you home and staying with until the morning following each treatment) will be given a 24-hr phone number and instructions regarding contacting the treating psychiatrist or, if he is not available, the on-call PAKC psychiatrist, with any concerns. You will be advised to not drive a vehicle for at least 24 hrs or until any lightheadedness clears up.
You will be contacted by phone by the treating psychiatrist 2-4 days after treatment to check on your status. You will receive a reminder phone call on the last office day before your next treatment.
You may experience one or more of the risks indicated below associated with ketamine treatment. In addition to these, there may be other unknown risks, or risks that we did not anticipate, associated with you receiving ketamine.
Although the overall potential physical risks of ketamine treatment are small, some risks described in this consent document, if severe, may cause death.
There are no physical risks associated with the psychiatric diagnostic and assessment procedures
Feeling lightheaded, “high”, exhilarated, and/or happy; having perceptual changes or hallucinations, floating sensations, and/or difficulty concentrating, paying attention, or remembering as many items as usual from a list (like items on a grocery list); mild and temporary increases in blood pressure.
Feeling dizzy, sleepy, anxious, suspicious, nauseated.
Feeling sad, scared, confused, and/or disoriented; moderate and temporary increases in blood pressure; future abuse of ketamine; prolonged psychosis in individuals with a pre-existing psychiatric condition. It is possible that the use of ketamine could increase interest in the illicit use or abuse of this substance although the fact that individuals with any past or current substance abuse are excluded from treatment makes this highly unlikely.
The risks of blood drawing and IV insertion include discomfort, bruising, and/or minimal bleeding.
Occasionally during blood drawing procedures, people may experience dizziness or feel faint.
Although rare, another risk associated with blood drawing and catheter insertion is infection at the site of insertion. Rarely irritation, redness, itching or rash may also occur if a topical anesthetic (numbing cream) is used.
- Age 18 or older..
- Current DSM 5 diagnosis of MDD
- Failed at least 3 adequate antidepressant trials
- Depression severity, duration or lack of response to traditional antidepressants are judged clinically sufficient to warrant ketamine treatment before considering remaining traditional treatment options.
- Suicidal ideations judged clinically to be of such severity to warrant ketamine treatment in an effort to achieve a rapid antidepressant response and reduction of suicidal ideations.
- The patient may have concurrent psychiatric diagnoses in addition to MDD if such disorders are judged to be of a clinical nature and/or severity that would not significantly increase concerns about psychiatric or behavioral risk when undergoing ketamine treatment.
- Identification of a responsible adult able to transport the patient to and from ketamine treatments and who is able to stay with the patient until the morning of the next day following each treatment.
- Determination of whether the patient has met the above inclusion criteria will be made after the PAKC psychiatrist in charge of ketamine treatment (“treating psychiatrist”) has:
- Reviewed the case with the patient’s PAKC attending psychiatrist
- Reviewed the patient’s PAKC records
- Personally performed a psychiatric evaluation of the patient
- A concurrent DSM 5 diagnosis of one of the major psychiatric diagnoses listed in item 2b below, as determined by:
- the PAKC attending psychiatrist
- information obtained from the patient’s PAKC chart
- the psychiatric evaluation performed by the treating psychiatrist
- Exclusionary psychiatric diagnoses include, but may not be limited to: Bipolar Disorder, Schizophrenia, Alcohol or Substance Abuse/Dependence not in prolonged and full remission and Major Neurocognitive Disorders. Patients with severe bipolar depression may be included at the discretionary judgment of the treating psychiatrist.
- Personality Disorder diagnoses that, in the opinion of the treating psychiatrist, could confound diagnostic issues, treatment response or adherence with follow-up requirements.
- Lifetime history of psychosis
- First degree relative with a history of schizophrenia, schizoaffective disorder major depressive disorder with psychotic features, Bipolar disorder with psychosis or other psychotic disorder
- Lifetime illegal use of ketamine or PCP
- CSSRS scoring that meets established guidelines suggesting that a higher level of treatment (e.g., inpatient psychiatric treatment) or clinical judgment of the treating psychiatrist that severity of suicidal ideations or behaviors precludes safe monitoring during the treatment period.
- Weight greater than 250 lbs. (Weight greater than 250 lbs might be deemed acceptable after review by the treatment team)
- Pregnant, breastfeeding or unwilling to use adequate birth control measures as determined in consultation with the patient’s Ob-Gyn.
- Certain medications known to reduce the effectiveness of ketamine, such as some antidepressants, antipsychotic medications commonly used along with antidepressants, antianxiety medications and anticonvulsants being used for the treatment of mood disorders, might be stopped or doses lowered before treatment with ketamine.
- Stimulants often used for the treatment of Attention Deficit Disorder/Attention Deficit Hyperactivity Disorder (ADD/ADHD) might be stopped for 2-3 days before each treatment in order to reduce potential effects on blood pressure during the treatments.
- Current treatment with any medications contraindicated with ketamine.
- Medical history or current medical conditions determined by the treatment team to preclude treatment with ketamine.
- Unable to provide informed consent.