Overview of Ketamine Therapies

Ketamine comes in several forms. The only one that the FDA has approved as a medication for depression is a nasal spray called esketamine (Spravato). It’s for adults who either haven’t been helped by antidepressant pills, have major depressive disorder, or are suicidal. They continue on their antidepressant and receive esketamine at a doctor’s office or in a clinic, where a health care provider watches over them for 2 hours after the dose.

For treatment-resistant depression, patients usually get the nasal spray twice a week for 1 to 4 weeks; then once a week for weeks 5 to 9; and then once every week or 2 after that.

The spray has a “black box” warning about the risk of sedation and trouble with attention, judgment, and thinking, as well as risk for abuse or misuse of the drug and suicidal thoughts and behaviors.

Other forms of ketamine not approved by the FDA for mental health conditions include IV infusion, a shot in the arm, or lozenges. Most research looks at ketamine given by IV. You can only get it by IV or shot in a doctor’s office. Some doctors will prescribe lozenges for at-home use -- often to keep depression at bay between infusions.

Collins, S. (2021). What is ketamine? how it works and helps severe depression. WebMD. Retrieved from https://www.webmd.com/depression/features/what-does-ketamine-do-your-brain

'Revolutionary' depression treatment brings hope to patients amid concerns about oversight

Goudie, C. (2019, April 5). 'Revolutionary' depression treatment brings hope to patients amid concerns about oversight. ABC7 Chicago. Retrieved September 18, 2021, from https://abc7chicago.com/spravato-what-is-ketamines-ketamine-clinics-near-me-nasal-spray-fda/5234673/.

**Please consult with your physician before using ketamine and the relevant scientific literature on its pharmacology and physiological effects.**

Medications/Treatments in Chicago

From the FDA News Release for Spravato:

The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS).

"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment. Because of safety concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient."

Patients with major depressive disorder who, despite trying at least two antidepressant treatments given at adequate doses for an adequate duration in the current episode, have not responded to treatment are considered to have treatment-resistant depression.

The Spravato labeling contains a Boxed Warning that cautions that patients are at risk for sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug. Because of the risk of sedation and dissociation, patients must be monitored by a health care provider for at least two hours after receiving their Spravato dose. The REMS requires the prescriber and the patient to both sign a Patient Enrollment Form that clearly states that the patient understands they should make arrangements to safely leave the health care setting to get home and that the patient should not drive or use heavy machinery for the rest of the day on which they received the drug. Additionally, Spravato must be dispensed with a patient Medication Guide that outlines the drug’s uses and risks.

The patient self-administers Spravato nasal spray under the supervision of a health care provider in a certified doctor’s office or clinic, and the spray cannot be taken home. The health care provider will instruct the patient on how to operate the nasal spray device. During and after each use of the nasal spray device, the health care provider will check the patient and determine when the patient is ready to leave.

The efficacy of Spravato was evaluated in three short-term (four-week) clinical trials and one longer-term maintenance-of-effect trial. In the three short-term studies, patients were randomized to receive Spravato or a placebo nasal spray. In light of the serious nature of treatment-resistant depression and the need for patients to receive some form of treatment, all patients in these studies started a new oral antidepressant at the time of randomization and the new antidepressant was continued throughout the trials. The primary efficacy measure was the change from baseline on a scale used to assess the severity of depressive symptoms. In one of the short-term studies, Spravato nasal spray demonstrated statistically significant effect compared to placebo on the severity of depression, and some effect was seen within two days. The two other short-term trials did not meet the pre-specified statistical tests for demonstrating effectiveness. In the longer-term maintenance-of-effect trial, patients in stable remission or with stable response who continued treatment with Spravato plus an oral antidepressant experienced a statistically significantly longer time to relapse of depressive symptoms than patients on placebo nasal spray plus an oral antidepressant.

The most common side effects experienced by patients treated with Spravato in the clinical trials were disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk.

Patients with unstable or poorly controlled hypertension or pre-existing aneurysmal vascular disorders may be at increased risk for adverse cardiovascular or cerebrovascular effects. Spravato may impair attention, judgment, thinking, reaction speed and motor skills. Patients should not drive or operate machinery until the next day after a restful sleep. Spravato may cause fetal harm and women of reproductive potential should consider pregnancy planning and prevention; women should not breastfeed while being treated.

Esketamine is the s-enantiomer of ketamine. Ketamine is a mixture of two enantiomers (mirror image molecules). This is the first FDA approval of esketamine for any use. The FDA approved ketamine (Ketalar) in 1970.

The FDA granted this application Fast Track and Breakthrough Therapy designations.

The FDA granted the approval of Spravato to Janssen Pharmaceuticals, Inc.

Office of the Commissioner. (2019, March 5). FDA approves new nasal spray medication for treatment-resistant depression; available only at a Certified Doctor's Office or clinic. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified

"Our Mission: To Make Ketamine Therapy Easily Accessible To The People That Need it The Most

Abhijit A Shinde, MD, PhD

Dr. Shinde is the medical director and has a special interest in patients with treatment-resistant depression and anxiety. He believes in an integrated approach. Depression and anxiety are symptoms and he wants to get to the root cause. He has a very respectful approach to every patient and believes each individual is different and unique. His approach is to work with patients, providing scientific evidence and logic for the proposed plan of care. Dr. Shinde highly encourages every patient to be very involved in his/her care. He is a member of the American Society of Ketamine Physicians.

Who can ketamine help?

01 — Those who deal with depression

While traditional antidepressants take several weeks, if not months, to offer any relief from depression, within just hours of an infusion, IV Ketamine has been proven effective for symptoms of depression. Researcher Elizabeth Ballard, PhD. of the National Institute of Mental Health, notably published a study that found Ketamine to ““reduce suicidal thoughts independent of its effect on depression or anxiety. 

02 — Those who struggle with anxiety

Ketamine has been studied and shown to be effective with an array of anxiety disorders, including SAD, general anxiety disorder (GAD) and relief is immediate rather than the 6-12 weeks normally required for chance of relief with traditional SSRI’s.

03 — Those who suffer from PTSD

In PTSD, there is mounting evidence for a role of the excitatory neurotransmitter glutamate in stress responsiveness, the formation of traumatic memories, and the pathophysiology of PTSD. Double-blind study demonstrated that infusion of ketamine rapidly and significantly reduces symptom severity in patients with PTSD compared with midazolam."

Website: https://www.balanceketamine.com/

Who We Are

Innovative Ketamine administers IV ketamine for the treatment of severe depression, mood disorders and chronic pain. Dr. Khare is a board certified emergency physician with experience administering ketamine. While working in the emergency department at Northwestern, Khare realized the challenges associated with treating mental illness in that setting. As an entrepreneur, he began exploring ketamine as a possible solution, and was among the first physicians in Chicago to offer ketamine infusions. Khare and his team have been successfully treating patients with IV ketamine since 2018. In March of 2019, he opened Innovative Ketamine, a dedicated clinic for IV ketamine infusions. We are proud to have an experienced team of providers who understand and specialize in ketamine treatment. We also have therapists on-site to guide patients through their treatment journey.

Will this replace my antidepressants?

No. Our primary focus is to provide safe and effective Ketamine infusions, we will not be managing any of your other medications or refill prescriptions. Ketamine infusions are meant to be an adjunct to your current mental health treatments and we are happy to collaborate with your psychiatrist and/or therapist. It is recommended that you wait at least 3 weeks after changing your medications before starting infusions. Please let the doctor know if you have recently changed any of your medications.

Website: https://innovativeketamine.com/