Author: Lori Calabrese, M.D.

FDA approves Spravato, a version of ketamine backed by Johnson & Johnson that sees rapid results in patients battling treatment resistant depression and suicide.

HOUSTON, March 5, 2019 /PRNewswire/ — “New FDA approved depression treatment, esketamine, is the biggest advancement in depression treatment in thirty years” – says Houston based Psychiatrist, Dr. Sandhya Prashad. This approval allows ketamine treatments to be more widely available and will likely be covered by various insurance providers for patients who have failed previous treatments.

Depression is the leading cause of disability worldwide, and an estimated 16.2 million adults in the United States have had at least one major depressive episode. According to a survey conducted from 2011 to 2014 by the U.S. Centers for Disease Control and Prevention, one (1) in eight (8) Americans age 12 and older are reported to have used antidepressants within the past month.

Ketamine has been hailed as the most important advancement in the treatment of depression in the past 50 years. Ketamine works on the NMDA receptor and modulates glutamate instead of serotonin, norepinephrine, and dopamine like traditional antidepressants. It is thought to help restore nerve synaptic connections in brain cells in people with major depressive disorder. It also works faster than other antidepressants. Patients often report symptom improvement in days instead of weeks. Suicidality also often improves rapidly.

Other psychiatrists in Dr. Prashad’s network have been sighted to confirm the drugs’ effectiveness and long-term results as per this weeks interview from the TODAY show: esketamine nasal spray discussed on the Today show.

Today, Johnson & Johnson’s nasal form of Ketamine, esketamine, which will be marketed under the name Spravato, was FDA approved. The long-term safety study showed that esketamine was generally tolerable, with no new safety signals with dosing up to 52 weeks. Discontinuation rates due to esketamine-related adverse events were low.

Traditional, conventional antidepressant drug treatments have a therapeutic lag of 3–4 weeks, and about a third of patients do not respond. At this time, ketamine has been available as an off-label treatment for depression and is not covered by insurance. Given the fact that ongoing treatment is required, it can become rather costly, and this has greatly affected its accessibility for patients. Johnson and Johnson has been developing a nasal version of ketamine called esketamine (Spravato) for treatment resistant depression. With FDA approval, insurance companies will begin to cover costs of the medication and make the treatment more widely accessible. The drug would be the first novel therapeutic for depression in 35 years.

“We’ve always prided ourselves in offering the most advanced treatments to our patients,” Dr. Prashad said. “Insurance coverage of esketamine will allow this life-saving treatment to be accessible to patients that need it. With one-third of those suffering from depression unable to respond to antidepressant medications, being able to provide relief to patients that are otherwise treatment resistant is a great opportunity.”

Dr. Sandhya Prashad, board certified Psychiatrist based in Houston, has specialized in treatment resistant depression and has been using ketamine in her practice since 2016. A graduate of Baylor College of Medicine for both Medical School and Psychiatry Residency, she has presented on the national level at conferences regarding the use of ketamine. She is a founding member and the secretary of the American Society of Ketamine Physicians (www.ASKP.org) which is a non-profit organization created to advocate for the safe use of ketamine for mental illness and pain disorders and to expand access to ketamine therapy. Dr. Prashad was also named one of Houston’s Top Doctors by H Texas Magazine for 2017, 2018 and 2019.

Patients may learn more about the treatment and the practice by calling 832-436-4055 or visiting www.houstonketaminetherapy.com

For Press Inquiries, contact:
Bianca Bucaram
The Bucaram PR Group
713-898-6552
bianca@bucaramprg.com

SOURCE: Dr. Sandhya Prashad

[Read the Original Post Here]

The psychedelic revolution has arrived—yet psychologists still have major gaps in knowledge about going on a shrooms trip in the name of mental health.

Michael Kuntz had been in talk therapy for a couple years, and felt stuck, like he wasn’t making progress on his anxiety or depression. “I found myself at a place where I couldn’t understand where this was all coming from, what was buried beneath the surface,” the 41-year-old said. 

Then, he started to read about the use of psychedelics for mental healthissues in clinical trials around the world. Michael Pollan’s 2018 book, How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression, and Transcendence, came out. Kuntz excitedly turned to his therapist for advice: What did she think about him trying psychedelics?

“And she told me, “Look I am starting to hear a lot about the subject myself,’” Kuntz said. ‘”But that is not something that I would not be able to work with you on, because of the sensitivities around legal issues.’”

Kuntz felt even more lost. He knew that recreational use of psychedelics was illegal in New York, where he lived, but that there were places in the world he could go to where they weren’t. He hadn’t wanted his therapist to give him drugs, just answer his questions.

As more people discover the research on psychedelics for depression, anxiety, addiction, they will find themselves in Kuntz’s position: asking their therapists and doctors for advice. But since psychedelics have been illegal for decades, they may find therapists who have gaps in knowledge or residual stigma about going on a shrooms trip in the name of mental health.

Meanwhile, FDA approval of MDMA for post traumatic stress disorder (PTSD) could arrive by 2021. In 2018, psilocybin got Breakthrough Therapy designation from the FDA, and the clinical trials for psilocybin depression treatment are in phase two of three. As we stand on the precipice of psychedelic treatments, there’s now a growing recognition that the therapist part has been neglected. There are not many clinicians who are able to guide people—not only during a trip, but before and after.

“There will be a great need for competent therapists trained in this clinical specialty,” according to a review on psychedelic therapists from 2017.

After some internet research, Kuntz found his way to Ingmar Gorman, a psychedelic integration therapist. Gorman doesn’t administer psychedelics, tell patients where to get drugs, or sit with people on drug trips. He is a new, emerging kind of therapist, expert in answering questions about psychedelic drugs, knowing what a psychedelic experience is like and how to help people make sense of it, and being up-to-date on the ongoing research.

There are not many clinicians who are able to guide people—not only during a trip, but before and after.

Gorman is a rare breed, and he knows it. Because of this, he and his colleague Elizabeth Nielson, a psychedelic researcher and therapist at New York University, have formed a company called Fluence, which offers training in psychedelic integration therapy. So far, over 500 therapists have gone to their training sessions.

“There’s a pretty big demand for this,” Gorman said. “And not enough education to meet it.”

Integration is a loose term, referring to the meaning-making and incorporation of a psychedelic trip into a person’s life. While it’s recognized as important, there hasn’t been much research on it. In one study on ketamine for depression from 2017, patients were randomized to get therapy after the infusions, or no therapy. The people who got therapy after felt relief from their depression for longer.

Integration therapy and support groups used to be places where people would process difficult trips. But the reality is more complex now. In the 2020 version of integration therapy, Gorman said that patients reach out to him for a wide variety of reasons—only some from having a “bad” trip.

Recently, a mother called him because her teenage daughter had depression and they decided to try ketamine infusions, which are legal, after no other treatments worked. When she mentioned them to her therapist, the therapist ended their relationship and called child protective services on the mother for allowing her daughter to receive ketamine.

“You don’t think about psychedelic integration when you think about that story, but what we do in our training is educate and inform so people don’t have the kind of stigma or fear response to working with clients who have had some sort of relationship with psychedelics,” Gorman said.

Another mother reached out after her daughter had done ayahuasca on a whim while on vacation with her friends. While on the drug, she had a vision of being sexually abused by her father. She approached the shaman and said, “This is what I saw, is this real?” The shaman told her that whatever ayahuasca shows you is true.

She turned to integration therapy for a more nuanced processing of what she had seen—which contradicted the way she actually felt about her father. As medical clinicians, Gorman said they don’t treat psychedelics as “sacred” or gatekeepers of truth. He would never tell someone what was “real” or not—his job was to work through how the experience was psychologically affecting his client.

These scenarios, along with other examples of complex patient experiences, are one part of what Gorman and Neilson present their trainees, in a program that’s been evolving and updated for the past six years. Their core workshops, Psychedelics 101 and 102 also offer a basic introduction to psychedelic drugs, their history, and current research with MDMA and psilocybin, clinical trials, and legal status.

Patients reach out for a wide variety of reasons—only some from having a “bad” trip.

A bad trip is something a therapist learns how to deal with. But what about a confusing one? Or a non-experience? Gorman said they teach therapists how to deal with a patient’s disappointment. “For a lot of people, even when it’s their first experience, this is not a quick fix,” Gorman said. “Sometimes it doesn’t work that way and they can really feel like they’re broken. That’s there’s something wrong with me because it works for everybody else but it didn’t work for me. And so we have a whole process around helping a person digest that disappointment.”

Therapists learn about how to address preconceived beliefs and expectations a patient may have towards the drugs, as well as biases a clinician might hold. “If therapists become too overly enthusiastic of psychedelics being purely helpful, they can alienate their patients who are having difficult experiences,” Gorman said.

When they started their training, Gorman said he thought they were going to see people who were already deep into psychedelics, with lots of experience. “That didn’t turn out to be true,” he said. “I would say that actually the contrary is true. The majority of the clients that I see are not people who come from the psychedelic culture.”

That’s who Ingmar wants to teach. His goal with Fluence is to reach out to clinicians who haven’t had a psychedelic experience. “That’s where it matters, you know?” he said. “That’s where we’re really making an impact in terms of educating people because people know very little if they have never done a psychedelic.”

He said that he and Nielson agree that a clinician doesn’t need to have had their own experience to help something with integration. “What I think is really healing for people is their therapeutic relationship, feeling like they can be heard and understood.”

Paul Ratliff, a 55-year-old marriage and family therapist who attended a training workshop, hasn’t had an experience with psychedelic drugs since he was in his 20s. He said that his interest started to be piqued again once he started reading about it in major media outlets. “Then, I think for myself, like a lot of other people, the publishing of Michael Pollan’s book was a pivotal event,” Ratliff said. “It was this indication of: Oh, this is going mainstream. I felt the door swing open. Part of my decision to formalize my exposure to it is a sense that this is the crest of a wave.”

“It’s not easy to get trained. It’s not really available.”

Marc Sholes, a psychoanalyst in New York for 30 years, said that psychedelic integration therapy, at its core, is not that different from traditional psychotherapy. But the kinds of experiences that can come up for patients are somewhat specific, hard to get access to, and practice on, elsewhere. “It’s not easy to get trained. It’s not really available,” Sholes said.

Ratliff said this stigma could deter a person from being honest with their therapists. “You want to be with someone who’s going to embrace this sort of experimentation you’re doing,” Ratliff said. “Even a small concern about being judged by your therapist could affect the therapeutic relationship.” He also came away with strategies for how to interact with a patient’s desire to take an illegal drug— in a harm reduction way.

“I think it’s really risky right now for everybody to be involved in this work,” said psychologist Signe Simon. “Patient and clinician.”

Though Simon doesn’t hold any personal stigma towards psychedelics, she wanted to hear about what those risks are, and what her responsibility and duties were as a clinician to keep her patients safe.

“It’s in such a gray zone right now that I think for me a lot of it was out of fear,” psychologist Simone Humphrey said. “This is something that I really want to work with, but I also want to know that I have the training necessary to handle something that might be unpredictable and might put the patient at risk or myself as a clinician. What am I legally allowed to disclose and not disclose? Is it okay to recommend? And all of the specifics around how to handle it.”

Psychedelics 101 and 102 is just one framework for psychedelic integration therapy. Gorman and Neilson are working on codifying it as much as they can, creating a manual, and setting up more formal accreditations.

But ultimately, there’s nothing stopping any clinician from saying they can help with psychedelic integration, whether or not they have experience, or biases about the drugs themselves.

In a paper in the Social Science Research Network, a social worker and psychedelic-therapy trainee Rose Jade argued that integration is a vague term, one subject to “hijacking.” “It may mean assistance akin to that provided in an FDA trial…or it could mean just post-dose talk therapy, or at times a mix of the above, or…something completely different,” Jade wrote. “It is a very vague term that is now being freely bandied about in conversations and used … in advertising by licensed health care professionals to attract clients and generate income for the professional.”

Just like psychedelic treatments, outside of a strict, clinical trial context, there’s no one monitoring or policing what exactly integration would entail.

And as it matures, as with other aspects of psychedelic medicine, access and cost are an issue. Multiple sessions with trained professionals is expensive, and if regular psychotherapy is rarely covered by insurance, psychedelic integration therapy will likely fall under the same umbrella.

It raises a sticky question currently plaguing the psychedelic medicine scene: do guides and integration specialists need to be therapists? Ratliff said that therapists “literally have a code of ethics,” and so he feels like people with a clinical background are best positioned to help. A clinician might be better equipped to deal with anxious and depressed patients who are curious about psychedelics.

The FDA doesn’t regulate psychotherapy, but medical devices can require a training program, like transcranial magnetic stimulation. Should someone wanting to treat people with, before, or after psychedelics be tasked with the same barrier?

“I think when we think about this process and we think about standards and we think about safety, that’s when my impulse is to say there should be some training, there should be some kind of formalized method because otherwise anyone can call themselves an integration therapist, potentially do damage,” Humphrey said.

The need for integration therapy isn’t going away. When Frank*, a middle-aged man living in New York, became interested in taking psychedelics, it was to help with his social anxiety. Frank hadn’t taken any drugs in 30 years, including alcohol—he is sober after having addiction issues when he was younger.

He wanted to see a therapist versed in psychedelics before taking anything, to help him create a safety net around his decision—for himself and those close to him. “My boyfriend was very concerned about his, and I was able to say, ‘Hey, I’m doing all these steps to make sure that I’m doing it in a good and in a cautious way,’” Frank said.

His previous therapist didn’t couldn’t respond to all of his questions. “You just cannot go to a random therapist and ask because they won’t know the answers,” Frank said.

Sherry Sacks, 46, had serious depression for about eight years. She had been in therapy, been on antidepressants, tried transcranial magnetic stimulation. “It came to a point where none of these things were working, and I fell into a really deep despair.”

Over the course of two years, Sacks did 11 ketamine infusions, the most recent last June. She started to see Gorman after her first couple treatments, not because she had a bad trip, but because she wanted a place to explore the meaning of the experiences.

“Anyone else, like your regular CBT or armchair therapist is going to be like, ‘That was a nice trip. You were on drugs. Of course you found that interesting,’” Sacks said.

“You just cannot go to a random therapist and ask because they won’t know the answers.”

With proper integration and preparation, a person’s experience with psychedelics could be enhanced. Gorman feels that the importance of integration may not necessarily be on everyone’s radar—especially given how hard it is to find an integration therapist besides searching online and asking therapists about their experience and credentials. “I would say that amongst lay people right now, there is a lot more focus on the experience itself, and not so much awareness on what happens afterwards.”

Kuntz ended up going to Synthesis, a legal psilocybin retreat near Amsterdam. He had been doing integration work for about three months before he went, through therapy, journaling, and reading. When he sat down with the others at the retreat, he felt much more prepared than everyone else.

“I was just ready for whatever was going to come at me,” Kuntz said. “It was almost as if the things that I had outlined in my journal, one by one, started to come up for me. Some of those things were terribly painful. I don’t want to paint a picture that I sat, smiling in bliss, for five hours. But the ability for me to be able to address some of these things, detach myself from it, examine them from a different angle, and really feel it—and then let it move through me and move to a place of acceptance… it just exceeded my expectations.”

*Name has been changed to protect privacy.

[Read the Original Article Here]