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Hope And Hype For New Type Of Antidepressant

Written by: | readers@forbes.com | Dated: Wednesday, June 24th, 2015

Two brothers – one an entrepreneur, the other a Columbia University psychiatrist – are claiming today that a new combination of experimental medicines may prevent suicidal thoughts in people with bipolar disorder.

The drug, D-cycloserine, was originally developed as a treatment for tuberculosis. Now, the brothers, Jonathan (CEO) and Daniel (scientist) Javitt, have founded a new company, NeuroRx, to develop it as an antidepressant. “Certainly neither one of us will say this is anything other than a very initial open-label study that is very preliminary,” says Daniel.

Reducing suicidal thinking would be a big deal. One in six bipolar patients commits suicide. But it also seems like a stretch based on what is actually being published on D-cycloserine – and NeuroRx is making a mistake by emphasizing that result in its press release this morning. The data come from only seven patients, and the claim about suicidal thoughts, made in a press release, does not actually appear in the report that’s being published in a scientific journal today. It was mentioned when the data were previously presented at a medical meeting.

Because the patients in the study were on other drugs, “the effect demonstrated in this study may simply highlight the role of D-cycloserine as augmentation technique of currently used medications,” says Aaron Pinkhasov, chairman of the department of behavioral health at Winthrop University Hospital.

“All findings could be due to placebo effect,” warns Raphael J. Braga, a psychiatrist at the Zucker Hillside Hospital of the North Shore-Long Island Jewish Health System.

But both Pinkhasov and Braga agree that the basic approach is promising as a new way to treat bipolar depression.

This is the state of affairs in a new area that might make depression more treatable, but which is so far hamstrung by studies that are too small and poorly designed for drawing firm conclusions. A decade ago, a study of the anesthetic ketamine, also abused as a club drug, improved severe, treatment-resistant depression in 71% of patients.

That set off a race to develop drugs that, like ketamine, work on a brain receptor called NMDA. Johnson & Johnson, one of the few big drug companies not abandoning the antidepressant field, is developing a nose-spray version of ketamine. Earlier this year, Naurex of Evanston, Illinois, is developing an NMDA-receptor blocker that is a pill and, unlike ketamine, doesn’t cause hallucinations.

“There’s a lot of hype about NMDA treatments for depression in general,” says Braga. “You can’t go to psychiatric meetings without hearing five or six talks about an NMDA receptor.”

One problem with ketamine is that it is given as an IV, but then only works for a week at most. Then the depression often returns. This is the problem that Jonathan and Daniel Javitt seek to solve. Daniel, the director of schizophrenia research at the Nathan Kline Institute for Schizophrenia Research, part of the New York State Office of Mental Health, was one of the first to characterize the NMDA receptor. He found that D-cycloserine also blocked NMDA.

An earlier randomized controlled trial in 23 patients was promising, but the effect took weeks to show up. But what if ketamine was used first, and then D-cycloserine was added after patients went into remission after being given ketamine?

That’s what the new study, published in the Journal of Clinical Psychiatry, attempts to test. Seven subjects completed the study; four of them were still in remission at the end of eight weeks. The patients had significant decreases in their scores on standardized surveys meant to measure their depression.

Promising? Sure, but there’s no control group. And the patients were given ketamine, the antipsychotic Latuda, and D-cycloserine. A better study would include more patients, and give all of them ketamine and Latuda but randomly assign some to get D-cycloserine and others to receive placebo.

Such studies are still to come. The ink on NeuroRx’s incorporation documents is not yet dry, and Jonathan Javitt says the company is not ready to announce any news about funding.

Source: Forbes

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