RALEIGH, N.C. (Ivanhoe Newswire) - Cholesterol, cancer, even infectious diseases: our blood can help doctors detect them all. Now, blood is being used to figure out what's going on inside your head.
It affects 15 million Americans and impacts women twice as much as men.
Angel Schwiefert was diagnosed with depression, also known as major depressive disorder, a few years ago. She tried three different anti-depressants.
"We really couldn't get the dosages right or the right medications," Angel Schwiefert told Ivanhoe.
"I worry that these meds are thrown at folks," James A. Smith, III, MD, Medical Director at Carolina Partners in Mental Health Care, told Ivanhoe.
Psychiatrist Doctor James Smith said with a wide variety of symptoms, diagnosing depression and getting patients the right treatment can mean a lot of trial and error.
"Piecing it all together can be a bit of a challenge," Dr. Smith said.
However, blood work could now take out some of the guess work. MDDScore is the first blood test to assist in the diagnosis of depression. With a routine blood draw, it measures nine biomarkers and ranks a person's likelihood of having the condition from one to nine. The higher the score is, the higher the chance of depression.
"I see it as extremely accurate," Dr. Smith explained.
In studies funded by the test maker, MDDScore was more than 90 percent accurate in catching depression.
"MDDScore more than anything else has given me an opportunity to hit it right on the nose," Dr. Smith said.
However, Duke Psychiatrist Dr. Harold G. Koenig has some concerns.
"False positives and false negatives, people who are diagnosed with depression with this test who don't have depression, or missing the depression potentially in someone who really has it who wouldn't get the treatment," Harold G. Koenig, MD, Professor of Psychiatry & Behavioral Sciences at Duke University Medical Center, told Ivanhoe.
Angel scored high on the blood test.
"I was totally surprised," Angel said.
She said her psychiatrist upped the dosage of her anti-depressant from 37.5 to 375 milligrams a day.
"I'm much better," Angel said.
Today, Angel's getting back to her favorite pre-depression hobby, refinishing, and believes MDDScore helped her get the life-changing treatment she needed.
Right now MDDScore is available in most states. Company officials say it should be available nationwide by the end of the year. While skeptical about the blood test, Dr. Koenig said it could be helpful in diagnosing major depression, but more studies are needed before he's convinced. Go to http://www.ridgedx.com/consumer.php for more information about the test.
BACKGROUND: Depression goes beyond feeling sad. It is a serious medical illness that affects a patient's thoughts, behavior, mood, feelings, and physical health. It is a life-long condition where patients experience periods of wellness with recurrences of illness. Every year depression affects five to eight percent of adults in the United States. Major depression, also known as clinical depression, and chronic depression, called dysthymia, are the two most common types. However, there are other types that have unique signs, symptoms, and treatment. (Source: www.webmd.com)
TYPES/SYMPTOMS: Major depressive disorder is characterized by a combination of symptoms that interfere with a person's ability to sleep, work, study, and eat. An episode of clinical depression can occur only once in a person's life, but it also can reoccur throughout a person's life. Chronic depression is characterized by a long-term (two or more years) depressed mood. It is less severe than major depression and does not typically disable the person. Atypical, or regular, depression's symptoms tend to be marked by pervasive sadness and a pattern of loss of appetite and difficulty falling or staying asleep. Although overeating, oversleeping, fatigue, extreme sensitivity to rejection, and moods that worsen are other symptoms associated with atypical depression. Seasonal depression is depression that occurs every year at the same time. It usually starts in the fall or winter and ends in the spring or summer. Psychotic depression's symptoms include delusional thoughts or other symptoms related with reality. Finally, postpartum depression is diagnosed when a new mother develops a major depressive episode within one month after they deliver the baby. It affects one in ten moms. (Source: www.webmd.com)
NEW TECHNOLOGY: There are numerous depression treatments available. Medications and psychological counseling are very effective for many people. However, often depression is misdiagnosed and depression can have a wide variety of symptoms. So, diagnosing depression and getting the right treatment for patients can mean a lot of experimentation. The MDDScore is a simple blood test that can aid in the diagnosis of major depressive disorder (MDD). It looks at a combination of biochemicals from four different biological pathways in the body. The blood levels of the individual body chemicals are measured and then entered into a mathematical equation to obtain a single test score. The score then represents a person's likelihood of having MDD. The MDDScore is not meant to replace traditional interview methods, but it is meant to add an unbiased element that compliments the patient interview. The benefits of a MDDScore include: it provides biological evidence to support a diagnosis, increases confidence and acceptance in the diagnosis, helps the patient and their loved ones better understand their medical condition, and it empowers the patient to accept and manage the disorder. Most insurance companies are reimbursing for the test. (Source: www.mddscore.com)
James A. Smith, III, MD, Medical Director at the Carolina Partners in Mental Health Care, discusses the MDDScore that is opening up new doors for diagnosing mental illness.
What is it like to try to diagnose someone with depression and treat them? Do you really have anything to go off of except for what they tell you?
Dr. Smith: Clearly for psychiatrists, we do practice the art of medicine. We take a history of the patient, review their symptoms, take a history of the patient's family, and then try to piece all that together. We go with our gut and read what we see in the patient's face, and then we try to make an accurate diagnosis. The American Psychiatric Association has given us DSM-4, which is the physical manual to help make a very appropriate diagnosis, and that does give us a bit of an algorithm to make a good diagnosis. However, the reality is all patients present with different types of symptoms. So, piecing it together can be a bit of a challenge. Most of us as psychiatrists have a pretty good handle on that, but there are times we run into some very difficult patients.
Is it frustrating when you cannot nail it down the way you want to or as well as you would like to, and maybe wonder if you had given the best treatment?
Dr. Smith: It is extremely frustrating because a patient comes back wanting to feel better and they felt badly for a long time. For many patients that come to us, they have been suffering for months before they see the psychiatrist. In fact, they will come through our door a little reluctantly. So, when they come see us, I am not saying they are after instant gratification, but they would like us to certainly treat them in an appropriate manner so that by the next visit they feel better. The struggle is that we have to frame it for them because even if I hit the mark with the right antidepressant, antidepressants still take ten to 14 days to build up in your system and then another week or more to get what I consider to be a therapeutic blood level to get a positive outcome. For many patients it is going to be about a month after I start them on medication. In some medications we have to titrate that medication up to the therapeutic dose, and so that can delay it as far as six weeks for many patients. Now, the struggle that I have with some of my peers is that I see people start low to avoid side effects, but when you start low you also have to let that patient know that you are going to lengthen out that process. If I start low, it might be a six to eight week process. So, I ask my patients to give me 90 days and if they could just hang in there for 90 days I'll do my best using my experience and strength to hopefully tease the situation out and tweak the medication in a way to give you some relief. That is what we are after.
If you have a case where you pick a drug and it turns out not to be the right one, do you have to start from scratch?
Dr. Smith: We do, but we always try to do our very best to listen. If that patient says that the medicine did not work because of side effects, then we would switch to a medication, maybe go to its second cousin or its first cousin. If the second cousin fails that patient, then I would switch to a different family of antidepressants altogether and go that route. Now, one little trick that we always ask is if their mother, father, sister, or brother had been on an antidepressant and they had a positive response to say, Prozac. Then I am going to cheat and I am going to start them on the Prozac because of the genetic similarities.
So how has MDDScore helped you fast track treatment or nontreatment?
Dr. Smith: MDDScore has given me an opportunity to hit it right on the nose that patients really do suffer from depression. If that person comes in with a litany of emotional symptoms and MDDScore comes back and it says it is not a depression, then I am looking at an anxiety disorder, a personality disorder, or another mood disorder that might not be antidepressant responsive. It could be a bipolar disorder where I might need to use a mood stabilizer versus an antidepressant. So, MDDScore, in my mind, really gives us a tool. Plus, I am very much into the medicalization of psychiatry and I think we need more of that. I think it allows us to be a lot more accurate and to hit it on the nose quickly, and we compare that with other new clinical tools to do better by our patients.
How does it work?
Dr. Smith: Basically what we are looking at is a score from one to ten. The higher the score, the more depressed that person is. Middle range is when you use your clinical intuition, but if I am getting a patient with a one or a two, I know I am going another route. A lot of times I see a number of folks struggling with personality styles that cause them difficulties in their emotional environment with friends, family, and coworkers and they are depressed by it, but they might not respond to antidepressant. So for me, I see MDDScore and that range allows me to figure it out. Now, if they come through the door with a nine or a ten, it is a no brainer. Then, it is just trying to figure out what medication I can prescribe that they are going to respond to and not have many side effects. If they are a four, five, or six, it is a gray zone. Again, we are then using our clinical intuition, their family history, and even their medical history so that you can then make a decision. We might treat them with an antidepressant or we might not. However, if I decide to use an antidepressant, in the back of my mind I might think that genetically they have a little more anxiety going on so I might use an antidepressant that works better on anxiety. One thing about antidepressants is that they are multifactorial in that some were greater for depression, some at higher doses work great with anxiety. If I am really treating them for the anxiety disorder, I might be giving them 40 mg Prozac for obsessive compulsive and that is more of an anxiety for me because they are anxious about their behaviors. So, it does allow me to still use medication, but I use it in a more targeted manner.
Does it focus on biomarkers in the blood?
Dr. Smith: Exactly. Clearly biomarkers are the wave of the future because these same biomarkers are going to be for every illness, depression, anxiety, bipolar disorder, and schizophrenia. I think that is going to be a great boon for psychiatrists. A number of people see their doctor to receive medication for mental illness and the doctors are not psychiatrists, so we need to give tools to our primary care doctors. Biomarkers are going to be very helpful even to the gynecologist because they prescribe a lot of medications of a mental health nature to the patients that they see. Biomarkers are going to help us hit the diagnosis on the head, give us an opportunity to quit the trial and error, and to turn people off from thinking, "hey he does not know what he is doing."
How did you start using it?
Dr. Smith: I read about it in a psychiatric newspaper. I saw information about Ridge, made contact, and they sent in a staff member. Chris and Dr. Williams, who is a CEO, all responded and I told them I wanted to be the first kid on the block.
So, you approached them. Were you were excited about it?
Dr. Smith: Yes, but they were here because they have been in an RTP for a while. I just looked at an opportunity for Carolina Partners to provide the ultimate and the most up-to-date psychiatric medical care as humanly possible. However, I struggle because my peer psychiatrists think, "Oh, I don't need that, I know how to diagnose depression." However, if you take a group of ten psychiatrists, you would be surprised how different we are all going to be. Biomarkers never lie; a gene is a gene, blue is blue, and brown is brown. So, I am pretty impressed that it helps eliminate some of that debate and our patients need that because they are suffering. They have probably been suicidal, maybe not necessarily acting on it, but they have been suffering and the family has been suffering; their wives, husbands, and kids have all been suffering. These patients are in need and using biomarkers will allow me to be more accurate first out of the gate and with the hope that we can give them the best possible clinical response.
How accurate is it?
Dr. Smith: I see it as extremely accurate. Now, I know that Ridge Diagnostics is doing their very best to keep this thing at the utmost efficacy in terms of right and wrong, but I see biomarkers as right on the money and I think Ridge has worked hard to perfect this. One of my reasons for even doing this interview is that I want Ridge to be successful because patients are going to benefit from this. I have no stake in this game other than as a clinician I want patients to get treated appropriately.
What is the cost to patients?
Dr. Smith: Most insurance will cover this. There will be a co-pay for some folks in terms of a lab cost. I also have to thank Ridge. When we started this, it was not covered and they ate the cost and I am grateful for that. There was a financial commitment on their part to help us get used to this. We were also blessed with a clinical trial invitation from Ridge and one of my nurse practitioners, Ms. Robin Cassidy, took on this task and we attempted to help norm MDDScore with the adolescent population. That is an ongoing investigation, but we were pleased to be a part of that and we were able to contribute a small number of patients to this overall research study with the idea that we could norm this not only for adults, but for adolescents as well. One of the important things about adolescents is that the FDA basically expressed many years ago that we had to give a black box warning for antidepressants because of suicidal thoughts. We also saw concern with giving teenagers antidepressants, but we saw the use of antidepressants to reduce the suicide rates in adolescents too. When the black box warning came out, the use of antidepressants in teens went down, suicide rates went up. We lost lives. Now, with Ridge and MDDScore being able to give that pediatrician, primary care doctor, or even psychiatrist who is seeing that 18 or 19-year-old the feeling that at least they have firm ground that the patient does have depression and they will have to put them on antidepressant. They will still have to be careful in monitoring that adolescent, but at least diagnostically they're hitting the target.
So there is an ongoing trial right now with that?
Dr. Smith: I believe that is definitely an ongoing trial.
Can you can you talk more about the cost for your patients?
Dr. Smith: With the co-pay, the cost is about 30 or 40 dollars.
What is it if there was no co-pay?
Dr. Smith: It is going to be expensive. It would be several hundred dollars.
What kind of results have you seen? Do you know how many people you have used it on?
Dr. Smith: Yes. I have actually used it on about 15 people and I do not know how many in the adolescent trial that our nurse practitioner has had, but I know we have used it quite a bit to the point that I'm very pleased with the responses. I'll talk about two cases; one case was where a women presented with a lot of anxiety and a lot of depression, but when we did MDDScore on her and she was a two. We treated her for anxiety and she said, "I thought I was depressed." A psychiatrist involved used a non-antidepressant to treat her anxiety; she had an excellent clinical response and realized that she did not know that her symptoms were anxiety because when you are feeling the emotions, anxiety and depression, it blurs so to speak.
The other case that I talk about all the time is a gentleman that had been seen by two previous psychiatrists and given multiple antidepressants. He came in to see me because his last psychiatrist unfortunately quit taking his insurance. So, he came to me because we did accept his insurance. I sat with him, listened to his story, and knowing that I had the MDDScore, I decided to go ahead and step it up a notch. He came back and was also at a two. I talked with him about slowly weaning him off of the medications because this is a gentleman that had been on antidepressants more than six years. He felt that he was doing okay, and when you are feeling okay you are really reluctant to say, "this doc wants to pull the rug out from underneath me here." So, trying to get him to understand what his diagnosis was and that maybe this is more related to a personality style that is causing conflict with your wife and some coworkers was difficult. I said, "allow me to wean you off this medication, but if you fall apart, I guarantee you I am willing to put you back on your medicine," to just reassure him that I was not here to pull away his safety net. Over a period of three months, I weaned him off his medication and gave him appropriate support during this time using cognitive behavioral therapy to help him learn some coping skills and was able to get him off meds. After that 90 day wean off, no meds. He comes back four weeks later and he is shocked, saying "I am feeling okay. I am still struggling with that CBT stuff doctor, but I am doing okay." He has effectively been able to stay off medication since that time except for an occasional need for some sleep meds because he's still having some issues related to interpersonal conflicts and having some sleepless nights, but not having the crying spells help us know that fatigue is what we see. We use a word, anhedonia, which is kind of like just down in the dumps so to speak. He has been able to manage without going back on medication and the nice thing here is he has learned better coping skills, he is not taking medication that he does not need, and I have reduced his medication costs or his out-of-pocket expenses. So, from a financial standpoint, he is a little better off. Emotionally, he is managing.
Are there any negatives to this that you see at all?
Dr. Smith: I really don't see any. I am a big fan of this with use among our primary care docs and our gynecologists because 70% of antidepressants are not prescribed by psychiatrists. I worry that these meds are thrown at folks, and when you have antidepressants with a black box warning that says be fearful of suicidal thoughts and completed suicides, that is a serious thing. In the hands of an untrained mental health professional, there can be some damage done. I just want the best for patients in general. We need to do a better job at educating our non-psychiatrists on how to make the diagnosis and what medications to use, and Ridge and MMDScore is going to give us a tool. I would love for them to get funded in a way that they could do a national rollout and put this test to use because not only will we reduce the amount of antidepressants being use, we will use antidepressants in a more appropriate manner. That is a good thing.
FOR MORE INFORMATION, PLEASE CONTACT:
James A. Smith, MD Medical Director Carolina Partners in Mental Healthcare JSmith5206@aol.com
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