Is ketamine the best hope for curing major depression?

http://www.bloomberg.com/graphics/2015-ketamine-depression-treatment/

The U.S. Food and Drug Administration hasn’t approved ketamine for the treatment of mood disorders, but dozens of medical studies show that it can quickly alleviate severe depression. There’s no regulation to stop doctors like Brooks from administering ketamine for nonapproved uses—a practice known as “off-label” treatment—but insurers typically don’t cover it.

Over the past three years, Brooks has treated about 700 patients, some who’ve traveled from as far away as Saudi Arabia, the Philippines, Israel, and Europe. He gets six to 10 daily inquiries from potential patients online. Of those Brooks treats, he estimates that about 70 percent show improvement. “For patients who are suicidal—and probably half of my patients are—they can get relief within an hour or two,” he says. “For patients who aren’t suicidal, it’s a little more subtle. It could be six to eight hours.”

Brooks plans to hire nurses and move into a bigger, private office this winter. He’s also working with Kyle Lapidus, a professor of psychiatry at Stony Brook School of Medicine who studies ketamine, to open several more clinics across the U.S. within the next few years. At least two more doctors in the Northeast, including psychiatrist Keith Ablow—a frequent Fox News guest known for making inflammatory remarks about everything from Michelle Obama’s weight to transgender people—have opened clinics and plan to launch chains and physician networks…

Ketamine was first developed in 1962 as a fast-acting anesthetic. It’s still used widely in operating rooms and for pain management. Beginning in the 1970s ketamine became popular as a recreational drug, known for putting users in a “K-hole,” likened to an out-of-body, near-death experience. In 1999 the U.S. Drug Enforcement Administration banned nonmedical uses for ketamine and designated it a Schedule III controlled substance, alongside drugs such as testosterone and anabolic steroids, meaning that it has moderate to low potential for physical or psychological dependence.

Around the same time, researchers at Yale, including Dennis Charney, who’s now dean of the Icahn School of Medicine at Mount Sinai, stumbled upon the drug’s promise as a mood stabilizer…

The group’s findings, published in Biological Psychiatry in 2000, were largely ignored. The study was tiny, and because of ketamine’s reputation as a party drug, scientists were reluctant to follow up. “They didn’t believe you could get better from depression in a few hours,” Charney adds. “They’d never seen that before.” Standard antidepressants such as Prozac and Wellbutrin take weeks or months to kick in. As many as 30 percent of depressed patients don’t respond to conventional antidepressants, according to the National Institute of Mental Health.

Six years later, Charney, who’d gone on to work for the National Institutes of Health, initiated a replica study with 17 patients. “This was a population that had failed on average six different antidepressants, and some had also failed electroconvulsive therapy, which is generally regarded as a treatment of last resort,” says Husseini Manji, one of Charney’s co-authors, who’s now the global head of neuroscience for Janssen Research & Development, a Johnson & Johnson company. Within a day of getting one ketamine infusion, 70 percent of the subjects went into remission. Since then, scientists at institutions including Yale, Mount Sinai Hospital, and Baylor College of Medicine have performed dozens more studies that corroborate the findings. Additional studies show that ketamine works by producing long-lasting changes in the brain, reversing neural damage caused by stress and depression and potentially decreasing inflammation and cortisol levels…

The FDA’s approval of ketamine for depression hinges on multiphase clinical studies, which are unlikely to happen. Pharmaceutical companies usually pay for clinical trials and can’t make money off a decades-old generic drug…

Instead, companies are spending millions to develop similar, patentable drugs. Janssen is seeking approval for a nasal spray made from esketamine, a variation of the ketamine molecule that’s about 20 percent more potent, says Manji. The spray could come on the market in a few years. Cerecor, based in Baltimore, is developing a pill that replicates ketamine’s effects. In June, the startup filed to go public and raise as much as $31.6 million. Pharmaceutical giant Allergan spent $560 million in July to acquire Naurex, an Illinois-based biopharmaceutical company whose main products are two clinical-stage ketamine-like drugs called rapastinel and NRX-1074. Both are designed to modulate the same receptor as ketamine, alleviating depression without inducing hallucination…

Doctors running the clinics are typically either psychiatrists or anesthesiologists. Prices for a single infusion range from $300 to $1,000 and often aren’t covered by insurance…

On a Monday night in July, Brooks is seated on a leather chair in his cramped, windowless office. The wall is hung with diplomas, scientific diagrams, and a landscape print from Santa Fe, N.M. …

Brooks’s patients range in background, but most are in their 30s and 40s. “Many people who suffer post-traumatic stress become overachievers,” he says. “They become very successful, rise very quickly, and then crash. They manage to get maybe to their early 40s, and then everything caves in.” About 20 percent of his patients are artists—writers, actors, musicians, and painters. “I get people who come in and say they haven’t picked up a paintbrush in three years, and after one ketamine treatment they’re up painting all night,” he says.

These days, Brooks is too busy to do much besides work. Recently, he treated a 16-year-old girl who’d been struggling with suicidal thoughts since she was 8. “She’d been hospitalized multiple times, self-mutilating, covered with scars,” he says. After one ketamine infusion, she told Brooks that it was the first time she could remember not wanting to be dead.

He says it’s hard to stay away from the office when there are so many people asking for help. “No one gets turned away, especially if they’re suicidal,” Brooks says. “It just gets more and more personal. I kind of see my son’s face in everyone who comes in.”

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