Arifulla Khan, MD, Medical Director ,Northwest Clinical Research Center, Professor Department of Psychiatry, Duke University School of Medicine talks about a new possible treatment for patients suffering with depression, who haven’t been able to find a treatment that works for them yet.
Interview conducted by Ivanhoe Broadcast News in October 2017.
Tell me a little bit about how you are treating treatment-resistant depression.
Dr. Khan: Depression (maybe better described as “melancholia”, which actually gives gravity to the situation) is a very common illness and there were really no treatments for it until about the last sixty years or so. There are a number of treatments now on the market, but the problem is that none of them are very powerful, so to speak. Only about half the patients, at best maybe sixty-percent respond to standard treatment. This problem has been recognized for about fifteen, twenty years now. Right now, we are looking at alternatives. There are certain alternatives, mostly combination treatments, which involve an existing antidepressant that is mixed in with what we call “antipsychotics”. But those sorts of combinations have lots of downsides to them and lots of side effects. So the alternative is to look at medicines that are much safer and that we know a lot more about and create combinations that could be effective. So that’s the purpose of some of the research that our center is involved in now.
The specific trial, the Axsome trial that you are working, how does that drug work?
Dr. Khan: The Axsome drug is very unique in the sense that it’s a combination of medicines that have been around a long, long time. Dextromethorphan is the active ingredient that is present in Robitussin, the cough syrup. But the problem is that the body effectively eliminates it in half an hour or an hour. So how to stabilize that so that the medicine inhibits the body’s breakdown of dextromethorphan (which is considered to be the potentially effective antidepressant) is the key behind the research. The other antidepressant, bupropion (or “Wellbutrin”), has been on the market for thirty years now. The combination of putting these medications together in a single pill, medications that we know are both very safe, having been used by multiple millions of people over the last thirty to fifty years, that’s why I think it’s an exciting development. We’re looking at the potential of providing benefit to people who don’t respond to the standard treatment, without having all the side effects of other combinations we have now.
What made you and the other researchers think that this would work for people who nothing else works?
Dr. Khan: It’s a proprietary idea from Axsome. Dextromethorphan is thought to work on what we call NMDA receptors which are thought to be involved in depression. The idea is stabilizing the dextromethorphan by using medicines which block its metabolism. There have been several attempts to do this without success, but the data that Axsome has generated is very promising. It increases the levels of dextromethorphan for a long period of time. So it’s simple, one pill a day, and that’s all you need to do.
Are you in Phase II for this trial?
Dr. Khan: Yes, this is a Phase II trial at the moment.
What can tell us about how it’s worked so far, the early results?
Dr. Khan: It’s promising, but they are all blinded studies so I cannot say that this medicine is working or not working. It’s very early, too early at the moment.
How long has the trial been running?
Dr. Khan: It’s been going on for several months now. And they’re still looking for patients to participate in this trial.
Do they have to live here?
Dr. Khan: There are multiple centers around the country. Those who are interested around the country can contact Axsome and they will point them to the nearest research center. There are over thirty centers in the country. Also there’s a website called clinicaltrials.gov and those who are interested in clinical trials should consider visiting the website and learning more about this trial.
How long will the trial go?
Dr. Khan: The duration of the trial is roughly fourteen weeks.
When will you close the trial and start amassing data to find out whether or not the drug is working?
Dr. Khan: The hope of the company is that they could have the results by early next year. And have some idea about the effectiveness of this combination by spring or summer of next year.
What kind of numbers are we talking about, people who are suffering from depression that don’t respond to anything?
Dr. Khan: The general sense is that depression affects somewhere between six to ten percent of adult population over their lifetime.
Americans or worldwide?
Dr. Khan: Worldwide. It just takes on different forms in different countries but it’s the same core elements. Out of these people, roughly about half seek treatment. So in the United States, somewhere between twenty and thirty million people suffer from depression at one stage of their life or other. About half of them are so severely ill that they seek treatment for it, and of these about half respond to first-line treatments and the other half do not. So our best estimates are that in the U.S. probably at least one-percent of the population (or roughly three million people) suffer from treatment-resistant depression.
How big is the effect of that? I know for those people it definitely changes the trajectory of your life. But in that how is that affecting the healthcare system insurance costs, is it huge?
Dr. Khan: Yes, the World Health Organization considers depression to be one of the top three illnesses that affect productivity, work, and family life … depression causes family disruption: divorce rates and suicides are extremely common among people with this disorder. It’s an enormous economic and financial burden not just to the society as a whole, but personally to individuals— it just changes their lives.
How big of an impact then would it make if this drug combination works?
Dr. Khan: Any combination you look at, for instance the Axsome medication, we can probably expect about half to two-thirds to improve with the combination. So if you’re looking at theoretically three million people that gives you an idea. It could be a potentially significant development.
What didn’t I ask you about the trial that you think is important to get out?
Dr. Khan: I think the key is that it’s safe. Theoretically it should also be effective, but that needs to be proven in the data. Safety is the most important thing with this medication.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
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