Over 20 medications are approved by the FDA for treating clinical depression – more than for almost any other indication. There are also multiple non-medication therapies: from Mindfulness Training to Transcranial Magnetic Stimulation. And yet about one of the three people affected by clinical depression does not respond adequately to the available treatments. This is about 5 million adults and a growing number of children in the U.S. alone.
But the hope is growing that this is about to change. The biggest development is rediscovery of a promising new drug, called ketamine. It is not entirely new: in 1970, the drug received FDA approval for use in people and was used on American soldiers in Vietnam as an analgesic and sedative. It was discovered in the late 90s that ketamine also provides a fast-acting relief from treatment-resistant depression. Problem was that it was also linked to bladder problems, cognitive deterioration, hallucinations, and addiction. As a result, as of now, ketamine is not FDA-approved for treating depression.
Patients can still get ketamine from private clinics run by psychiatrists or anesthesiologists who prescribe the drug “off-label” – and some do. Time magazine reports that the cost of treatment, which is rarely covered by insurance, runs from $400 to $800 per bi-weekly infusion. What’s more, according to Time, there are no rules governing how these clinics administer the drug or monitor side effects. Yet the high cost and unknowns risk do not stop some depression sufferers, who see ketamine as their last hope.
For years, developing a drug that would work similar to ketamine, but without its side effects (and could therefore receive FDA approval), remained the holy grail. But now two leading pharma companies, Allergan and Jonson & Jonson, appear to be close to the target. One promising compound is rapastinel, a new medication being developed by Allergan. According to the company, rapastinel is given by IV and brings relief within hours. What’s more, according to the company, it does not cause hallucinations. Rapastinel received “breakthrough” designation from the FDA, and is in the final stage of clinical trials.
Another drug is esketamine, developed and patented by Johnson and Johnson. Esketamine is delivered through the nose, similar to nasal decongestant. J&J reports that Phase II trials have shown “dramatic results, with some patients responding to treatment within hours” and that while there were some common side effects, such as dizziness and small increases in heart rate and blood pressure, “they were temporary and resolved within two hours”. Similar to rapastinel, esketamine has been designated by FDA as “breakthrough therapy”, which means that it is expected to receive priority review from FDA.
“Esketamine and rapastinel are, without doubt, the most exciting new developments since Prozac in 1987”, says Dr. Alex Stolyar, Associate Clinical Professor at Harvard Medical School and Principal Investigator at Boston Clinical Trials, “If proven successful, the whole landscape of depression treatment is going to be different.”
Boston Clinical Trials is among the selected group of institutions conducting clinical trials of esketamine and rapastinel. All medications and study-related care are free of charge to the participants. To discuss whether participating in these trials is right for you, please call us at 617.477.4868 or click here to visit our depression studies page.