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Young people suffering from treatment-resistant depression (TRD) showed a significant reduction of their symptoms after being administered ketamine injections, according to a study published in the Journal of Child and Adolescent Psychopharmacology.

Researchers from the University of Minnesota (UM) and the nonprofit Mayo Clinic found that ketamine caused an average decrease of 42 percent on the Children’s Depression Rating Scale(CDRS)—the most widely used rating scale in research trials for assessing the severity of depression and change in depressive symptoms among adolescents.

Ketamine is perhaps best known for being a popular recreational drug and a useful medical anesthetic, but a growing body of research is indicating that the compound could be an effective treatment for depression. Several recent studies have shown that even a single dose in adults can lead to rapid reductions in depressive symptoms. However, relatively little research has been conducted into ketamine’s antidepressant effects in adolescents.

“Adolescence is a very important time for studying depression, first because depression often starts during these years, and second because it is an important time for brain development,” Kathryn Cullen, from the Department of Psychiatry at UM, told Newsweek.

“When adolescent depression persists without successful treatment, it can interfere with achieving important developmental milestones. Finding the right treatment is critical to allow the restoration of healthy brain development and prevent negative outcomes like chronic depression, disability and suicide.”

Unfortunately, about 40 percent of adolescents do not respond to their first intervention and only half of nonresponders respond to the second treatment, according to the researchers.

“Standard antidepressant treatments do not work for everyone and take weeks to months to take effect, a time period when patients are at risk for continued suffering and suicide attempts,” Cullen said. “The field is in need of new treatment options. Ketamine has a very different mechanism of action than standard treatments.”

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The latest study involved 13 young people ages 12 to 18 who had failed two previous trials of antidepressants. During a two-week period, the researchers gave them six ketamine infusions.

They found that the treatment was well tolerated, with the participants showing an average decrease in CDRS scores of 42.5 percent. Five of the participants met the criteria for clinical response and remission. Of these, three were still in remission after six weeks, while the remaining two relapsed within two weeks.

According to the scientists, the results demonstrate the potential role for ketamine in treating adolescents with TRD. However, they note that the study was limited by its small sample size, so future research will be needed to confirm these results.

“The purpose of our study was to investigate the effects of ketamine for TRD in younger patients for whom this indication for ketamine administration is not well studied,” Mark Roback, a professor of pediatrics at the University of Minnesota, told Newsweek.

“I think our results show promise for this population, however this study is just a beginning. The study serves to point out the need for further, rigorous, study designed to answer the many questions that remain about ketamine for TRD, such as optimal dosing and route of administration, dosing interval and treatment length, and long-term effects—just to name a few.”

A teenager suffers from depression in this stock photo. Adolescents experiencing treatment-resistant depression (TRD) showed a significant reduction in their symptoms after being administered ketamine injections, according to a study.ISTOCK

James Stone, a clinical senior lecturer from the Institute of Psychiatry, Psychology and Neuroscience at King’s College London, who was not involved in the study, told Newsweek that there is “a lot of potential for the use of ketamine as a second or third line antidepressant where other treatments have failed.”

“Although ketamine is potentially a huge breakthrough in the treatment of depression, we still don’t know about the long-term safety, or about how to keep people well from depression without requiring regular ketamine dosing,” Stone added. “Further studies are needed to address these questions.”

This article has been updated to include additional comment from Kathryn Cullen.

[Read the Full Article and Watch the Video HERE]

Johnson & Johnson and Allergan are now testing new drugs for depression that are based on ketamine. There are still safety concerns.

After 35 years of mediocre depression drugs, pharmaceutical companies are jazzed about several new drugs inspired by the club drug ketamine.

Allergan, the multinational pharmaceutical giant known for Botox and birth control, recently dove into research on an injectable depression drug called Rapastinel.
Most recently, the company announced it was working on oral pill version of that drug.
After nearly four decades of dispensing the same mediocre medications to patients with depression, pharmaceutical companies are jazzed about several new drug candidates inspired by the club drug ketamine.

Allergan, the multinational pharmaceutical giant known for Botox and birth control, recently dove deep into research on an injectable depression drug called Rapastinel, which works on the same brain pathway as ketamine.

The company plans to file for approval with the Food and Drug Administration within two years. Last week, Allergan also announced plans to go after an oral pill formulation of Rapastinel that would be easier to take and more widely used.

The development “points to the general air of excitement in this area,” C. David Nicholson, Allergan’s chief of research and development, told Business Insider.

Allergan isn’t the only pharmaceutical company that is hot on the trail of new depression drugs inspired by ketamine. Johnson & Johnson is pursuing esketamine, the chemical mirror image of the drug, in a nasal spray formula.

After publishing positive clinical trial results earlier this month, the company told Business Insider it planned to file for FDA approval of the drug this year. VistaGen, a small San Francisco-based drug company, is studying a drug similar to Allergan’s Rapastinel called AV-101.

All of those efforts hint that a new blockbuster depression drug could be just around the corner — all thanks to a club drug once known chiefly as “Special K.”

A reawakening for new depression drugs inspired by ketamine
prescription-pills-medicine-in-hand
perfectlab/Shutterstock
Scientists recently called ketamine, a drug most people know either as a surgical anesthetic or a party drug, “the most important discovery in half a century.” The drug landed on researchers’ radar after swiftly lancing depressive symptoms in people — including suicidal patients— with some of the hardest-to-treat forms of the disease.
But ketamine is difficult to give patients (it’s generally administered via an IV drip over roughly 45 minutes) and does have some negative side effects (many people describe a dissociative, quasi-psychedelic sensation of floating outside of their body, for example). Ketamine is also expensive, and most insurance providers don’t cover it.

Drug companies are looking for candidates that mirror ketamine’s positive qualities while minimizing its negative side effects. Injectable drug candidate Rapastinel could be Allergan’s answer to this quandary.

“Now that ketamine has shown improvements in depression, it has reawoken interest in this area. And Rapastinel appears to combine the best of all worlds in terms of efficacy and safety,” Nicholson said. “I believe it will be a breakthrough and will be used extensively.”

But despite showing hugely positive results in clinical trials so far, Rapastinel still faces one road block: it’s a shot, and people don’t like shots.

So while Rapastinel moves through the drug approval process, Allergan is also eyeing an oral pill formula which would hopefully either mimic or at least complement Rapastinel’s effects. If successful in clinical trials, the pill could also be used “more widely” than Rapastinel, Nicholson said.

‘As soon as there’s a breakthrough all those other companies that dropped out will want back in’
For now, Allergan’s new oral pill depression drug candidate is known only as AGN-241751. Like Rapastinel, AGN-241751 was initially developed by a company called Aptinyx. In 2015, as part of a $560 million deal with the company, Allergan nabbed the rights to develop and commercialize both drugs.

The deal sheds light on Allergan’s renewed strategic focus on new neuroscience drugs, Nicholson said. In the past, the drugmaker has worked on medications designed to treat migraines, Parkinson’s, and Alzheimer’s; depression is the latest arm of that research focus.

Nicholson also believes that the interest he’s seeing in ketamine-inspired drugs could be the breakthrough needed to stir-up renewed interest among drugmakers in the neuroscience field, which declined somewhat after several promising Alzheimer’s drug candidates failed to turn into treatments.

“We see a great future in neuroscience research and development. These things tend to go through cycles. There’s a breakthrough, and Rapastinel hopefully will be one of those breakthroughs. And as soon as there’s a breakthrough all those other companies that dropped out will want back in.”

Anne Stallings says she has been battling severe depression for most of her life. She tried anti-depressants and even electroconvulsive therapy, but nothing worked until she went to a Potomac, Maryland, clinic and tried ketamine, reports CBS News correspondent Paula Reid.

“It was like the fifth treatment in and I had come home from the grocery store and I was putting away the groceries and I was like, ‘Wow, this is how you don’t feel depressed.’ It was like from turning on a black and white TV to a color TV,” Stallings said.

Ketamine was approved by the FDA in the 1970s to sedate patients during medical procedures. It is more commonly known as an animal tranquilizer and in powder form as “Special K,” a club drug used to get high.

Today, ketamine is being provided legally off-label to treat depression at an estimated 250 clinics across the U.S.

Dr. Steve Levine offers intravenous ketamine infusions at several clinics around the country as an alternative to common anti-depressants. He says he treats about 70-80 patients across all the offices on any given day.

“Everything for the past 50 years has been based on the chemical imbalance theory of depression which has never held water,” Levine said. “So all these medicines, while they do help a lot of people, are based upon a flawed theory. And that is probably one of the reasons why they do take so long to work. They all take weeks to months to work so here is a medicine that people can take infrequently that is based upon a theory of the brain that makes a lot more sense and it works almost immediately.”

Stallings didn’t have time to wait. She had an especially hard time over the holidays and when her father got sick, she thought about taking her own life.

“I actually had suicidal ideations and the one thing about ketamine was that I was able to get in here emergently because I knew what was going on and when I left here my suicidal thoughts were gone,” Stallings said.

That is in line with what Columbia University discovered in one of the largest studies yet on ketamine. Researchers found the drug was significantly more effective than a commonly used sedative in reducing suicidal thoughts in depressed patients. The effects lasted up to six weeks.

Twenty-two-year-old Marc Nelson ditched his antidepressants for ketamine and talk therapy. He says he now feels more like himself, but it came at a cost. He has spent more than $10,000 on treatments.

“So many different drugs that I am now off of all of them, which you know, the side effects were just not tolerable to me. They make me a zombie. I was not happy,” Nelson said.

But these infusions can have their own pitfalls. Ketamine can cause people to feel detached from their bodies.

“The 45-minute period of very floatiness, I sometimes get nauseous,” Nelson said. “It’s a very interesting process. … I just lost my train of thought.”

Once the treatment was finished, Nelson said he felt “clear, cognizant” and “definitely able to pronounce” his words again.

Asked to address critics who say he’s making money by giving people the opportunity to get high, Levine said, “I would say that if you ask any of our patients none of them feel that they are getting high.”

“People tend to focus on the party use of ketamine, because it is more exciting, it’s sexier in some way. It does it a disservice because that’s a very small fraction of its use,” Levine added. “And as far as the money making aspect of this, if you were doing things in the right way you’re not gonna make a lot of money.”

Ketamine has piqued the interest of some major pharmaceutical companies. There are half a dozen drugs in development that mimic the way ketamine works, with some undergoing FDA clinical trials for approval as antidepressants.

For decades, Dr. Gerry Sanacora has been studying ketamine at Yale.

“What we’re trying to understand is what does it change in the brain that allows that sustained anti-depressant like response?” Sanacora said.

He says the drug is not addictive in the way opioids are, but could still be harmful in the long run.

“There is at least evidence in animal models that these type of medications can actually cause some structural damage in the brain. That’s usually at higher doses, that’s usually at longer term exposure but we don’t know where that level is,” Sanacora said.

Dr. Levine said he monitors patients closely.

“In our population even people who have been having ketamine on a maintenance basis for up to six years now we haven’t seen any sign of that,” Levine said.

But for Anne Stallings, despite the unknowns, she’s content with a chance to feel normal.

“If I can live a quality, happy life, and be productive, be able to go to work, to be able to have my family, to enjoy life – not walk through life but enjoy life – then it’s worth it.”

[Read the Original Article]

Ketamine, known mostly as a party drug, has assumed a new identity in recent years—as a promising antidepressant. And, though research is still under way, it seems to reduce symptoms of depression very quickly, and in people who haven’t been helped by traditional antidepressants. Now, a study published in the American Journal of Psychiatry finds that for depressed people who have suicidal thoughts, it may also help alleviate these thoughts much faster than anything that exists currently—within hours.

The study, carried out at the Columbia University Medical Center and the New York State Psychiatric Institute, looked at 80 patients with clinical depression. They all had suicidal thoughts that were intrusive enough to fall into the category of clinical suicidal ideation. The participants were randomized to receive a low-dose infusion of either ketamine or midazolam, a sedative; they were followed for six weeks, during which time the participants all received usual psychiatric care. To measure their depressive symptoms and suicidal ideation (thoughts or urges), the participants filled out questionnaires, like the Scale for Suicidal Ideation and the Beck Depression Inventory.

Within 24 hours, the participants who’d received ketamine reported significant changes in symptoms compared to those receiving midazolam. They had a reduction in suicidal thoughts, depressive symptoms, and fatigue. In fact, the participants who didn’t respond to midazolam were later given ketamine, and they showed the same improvements.

And these changes seemed to last for up to six weeks. The side-effects, which were mainly dissociation—a sense of detachment—and increased blood pressure, resolved within minutes or hours after the ketamine injection.

When the researchers teased apart the variables, they found that the reduction in depressive symptoms accounted for only a third of the reduction in suicidal thoughts, which suggests that ketamine’s effects on suicidality comes from more than just a reduction in depression. What that might be still needs to be explored.

“Adjunctive ketamine demonstrated a greater reduction in clinically significant suicidal ideation in depressed patients within 24 hours compared with midazolam, partially independently of antidepressant effect,” the authors write.

Suicide rates in the U.S. have risen a lot in recent years—according to the CDC, they’ve increased by almost 27% percent between 1999 and 2015. It’s particularly concerning since young adults and teens—especially girls—represent an especially large part of the rise.

The study builds on a growing body of literature suggesting that ketamine may be a real player in depression treatment, which hasn’t changed much over the years. As most people know, the usual antidepressants can be ineffective for some people; and for those for whom they work, it can take many months to find the right one, since they can take several weeks to kick in. For people who are suicidal, it’s especially critical to find faster and more effective treatments.

“There is a critical window in which depressed patients who are suicidal need rapid relief to prevent self-harm,” said study author Michael Grunebaum in a statement. “Currently available antidepressants can be effective in reducing suicidal thoughts in patients with depression, but they can take weeks to have an effect. Suicidal, depressed patients need treatments that are rapidly effective in reducing suicidal thoughts when they are at highest risk.”

More work will need to be done to understand ketamine dosing, especially over the long-term, as well as long-term side-effects that may develop. Some doctors are already offering ketamine infusions for people with treatment-resistant depression, although it’s not approved by the FDA for this purpose. (And people should not be self-administering ketamine, since at the wrong dose it can be harmful, addictive, or fatal.)

So far the results are encouraging, and it will be exciting to watch the developments as they come in. “Additional research to evaluate ketamine’s antidepressant and anti-suicidal effects,” said Grunebaum, “may pave the way for the development of new antidepressant medications that are faster acting and have the potential to help individuals who do not respond to currently available treatments.”

[Read the Original Article on Forbes.com]