Francisco Romo-Nava, MD, PhD, Associate Chief Research Officer, Lindner Center of Hope, and Assistant Professor, Department of Psychiatry and Behavioral Neurosciences, University of Cincinnati, talks about a new treatment method for depression.
Can you describe what you and your colleagues are studying in terms of mind-body connection for some mental health conditions like depression and anxiety?
ROMO-NAVA: It’s been several decades since we started noticing people with psychiatric disorders tend to get sick more often from other things that are not psychiatric disorders. As evidence continued to mount, we also observed that some of the symptoms that are part of the different psychiatric syndromes also include functions that affect not only what was traditionally known as the mind, but also bodily function. A very clear example can be observed in patients with a mood disorder, either major depressive disorder or bipolar disorder. For example, in those two conditions, you have two kinds of symptoms that integrate the depressive syndrome. One is the cognitive part, which is the sadness or difficulty in enjoying things. Then, you also have a disturbance in the sleep-wake cycles and in appetite regulation. You also have a disturbance of interest in sex. You can have a myriad of somatic symptoms that are sometimes considered medically unexplained. So, all of those parts of the depressive syndrome in addition to the association of major depressive disorder or bipolar disorder to increased mortality due to non-psychiatric conditions such as obesity-related or cardiovascular disease and early mortality observed because of those comorbidities tell us that these are multisystemic conditions that involve not only brain function, but also bodily function.
So, you and your colleagues are looking at something unique or a little bit different for treating these conditions? Can you tell me about that?
ROMO-NAVA: In the journey of trying to investigate these brain-body communication disturbances like depression, we were trying to look at different and more robust pathways that we could identify. We came up with two pathways that we think are very important to this brain-body communication. One is the circadian system that involves the way in which our biological clock can arrange and shift our bodily function according to its needs, activity, and rest periods. The other pathway is if there’s a flow of information coming from the brain to the body, then let’s look at how the information comes back from the body to the brain and try to see how important this might be for the actual symptoms that we observe in depression. So, through the work of others, we’ve been focusing on the sensory pathways, which is a study funded by the Brain and Behavior Research Foundation as a Young Investor Award and focused on a part of the spinal cord that is called the dorsal horns. This pathway has been proposed for what we consider or conceptualize as mood. The purpose of this study and this approach is the result of our brain’s ability to be able to read the information coming from our body and make it conscious. And then, of course, the brain readjusts the bodily function according to that feedback. So, we can look at the brain-body communication as a feedback sequence that regulates itself. It’s important to identify the actual role of these sensory pathways in the context of major depressive disorder and whether this could modify or have an impact in the whole depressive syndrome.
Can you explain a little bit about the device and what you’re looking at specifically with the stimulator?
ROMO-NAVA: We’re trying to use what is called a transcutaneous direct current stimulation, which is a non-invasive spinal cord tool. What we’re trying to achieve is not to stimulate, but to decrease the information that is coming from the body to the brain and from the brain to the body so we can give the system a break. Through repeated sessions following some of the stimulation protocols that we’ve seen used in transcranial neuromodulation, we are starting at the frequency of three times per week, 20 minutes per session for eight weeks. We’re utilizing relatively low current density that we know from other studies is sufficient to be able to modulate and reach the targets in the spinal cord. Then, what we expect is that the information and the signaling from the spinal cord can shift and also have an effect in the brain areas that have been involved in mood regulation. We’re trying to investigate with this pilot, proof of concept study and are trying to achieve two things. One is to provide some evidence of this extra cerebral component to the depressive syndrome. And then, we will try to evaluate whether there is a signal that this approach may have an influence on the depressive symptoms.
So, patients can feel the stimulation? Is it painful? Is it uncomfortable? Do they feel an effect immediately after?
ROMO-NAVA: The kind of stimulation that we use is very well-tolerated, even though our protocol allows for us to be able to decrease the starting core intensity. We’re using a double-blind design in which we utilize an active version of the stimulation and a sham version of the stimulation on both of them. Participants may be able to feel something. The most frequent description is like a tingling sensation. We have not encountered that it is described as a painful sensation or as something that is uncomfortable.
Is there anecdotal evidence that after a period of sessions the patients feel better?
ROMO-NAVA: It’s difficult to tell because we do have this disaffected blinding. What I can tell you is that we have observed that none of the participants have gotten worse, which is a good thing. The challenge in depression trials is being able to identify the difference between the intervention and the placebo effect. What we’ve observed is that some participants have a pretty significant decrease on the overall depressive symptoms severity scale scores, while others, even though they have a decrease in such severity scores, it’s not as large as others.
Why is it important to have another tool, another option, for patients with depression and major depressive disorder?
ROMO-NAVA: It’s important because depression is a serious illness that affects many aspects of an individual’s life. Even though there’s a wide variety of approved and effective treatments for depression, not all patients respond to the medication or to the neuromodulation approaches that are currently available. And, not all patients respond to psychotherapeutic approaches. So, there’s an area of opportunity to try to offer or come up with more tools that could potentially be effective in decreasing or treating depressive symptoms. Of course, this is a very initial step in trying to investigate this approach. But we think that if we’re able to observe a signal, then it would warrant a larger study and have the statistical power to be able to test the efficacy and the safety of this procedure in a larger clinical trial. And of course, one of the potential advantages of neuromodulation tools in the treatment of neuropsychiatric disorders is that it may be able to avoid some of the side effects that may be observed with some of the medications that are currently available.
Is there a name or title to the trial and name of the neuro-stimulating device or is it just a neurostimulator?
ROMO-NAVA: There are two aspects that are probably important to mention. One is, we are currently utilizing transcutaneous direct current stimulator. It’s a specific one and only available for investigational purposes. The actual patent that was issued was because of a method, not a specific device. But it’s a method to modulate spinal cord to investigate this as an option for psychiatric disorders.
For a larger scale trial, would that just be your center or would you involve other centers if you needed to recruit additional people?
ROMO-NAVA: We would try to find a way to collaborate with other institutions or with other private companies or try to see what’s the best way to continue to evaluate this approach. At this moment, we need to utilize a single protocol of stimulation, but it is also necessary to investigate other intensities and other frequencies. I think it has a great potential.
Can you tell me what schizoaffective disorder is and how it’s different from, or is it different from, schizophrenia?
ROMO-NAVA: That’s a very good question because schizoaffective disorder is a not-so-logical entity. It’s a classification that is used to describe those symptoms that occur to patients what we call the psychotic symptoms and the mood disorder symptoms. For the purpose of trying to understand psychiatric disorders, we try to put together a classification system that allows us to describe and to group symptoms and then try to put together a syndrome that we call either schizophrenia or either a mood disorder or anxiety disorder in this case. Schizoaffective disorder is a disorder that is characterized by some of the psychotic symptoms that are observed in schizophrenia, such as hallucinations, delusions, disorganized speech, disorganized behavior, the negative symptoms. In this case, they’re social depressants of major mood episodes. What that means is even though some patients may suffer from major depressive episodes, this would be different in the sense that in patients with a schizoaffective disorder, you would observe the presence of a major mood episode, either major depressive episodes or mania episodes that are present for a good portion of the majority of the duration of the illness. Then it can be seen from also the other side. So, what’s the difference between schizoaffective disorder and bipolar disorder? Sometimes, patients with bipolar disorder can also have psychotic symptoms throughout the different mood episodes. The difference is that in schizoaffective disorder, you can observe the psychotic symptoms without the mood symptoms, even though there may be major mood episodes present. That’s one of the major neurological differences between the three conditions, schizophrenia, schizoaffective disorder and bipolar disorder, or even unipolar, major depressive disorders that could also present with psychotic symptoms. There’s still discussion as to the reliability, the validity and stability of this disorder because this is a disorder where a diagnosis is made throughout the evolution of the symptoms of a particular individual. So, you need to observe, go back and follow the symptoms in that particular individual to be able to see how the different criteria might be met and the evolution of those particular symptoms.
How important is it to be able to diagnose which of the three it is, and does that make a difference in treatment?
ROMO-NAVA: Yes, there’s certainly some difference in terms of the treatment options. The difference may be clearer between the treatment for schizophrenia and bipolar disorder. The difference between schizoaffective disorder and the others would depend on the presentation of the different symptoms. So sometimes, even though the primary treatment for schizophrenia may be based on antipsychotic medications, it is possible that patients with schizophrenia may also have an episode of depression at that moment. It may be necessary to include antidepressant medication. On the other side, with bipolar disorder, even though the primary treatment may be based on mood stabilizers and the combination of other types of medications as it is needed for the evolution of a particular patient, in schizoaffective disorder, it would be the same thing. Antipsychotics may be needed in addition to other mood stabilizers or antidepressant medication, according to maybe the subtype of schizoaffective disorder and the presentation of symptoms.
How common is this and is there a cure for it?
ROMO-NAVA: That’s a very difficult question to answer because, in terms of epidemiological studies, schizoaffective disorder is usually combined or studied or reported in conjunction with schizophrenia spectrum disorders. It is estimated that, in terms of epidemiology, it’s less frequent than schizophrenia. Some say it may be one-third that of schizophrenia. Schizophrenia is usually considered to be present between point five on .75% of the population. So the exact prevalence of the schizoaffective disorder needs much more study in terms of that.
What would you say to people about this condition in terms of people misunderstanding what’s going on? How do we start alleviating the stigma and getting rid of the stigma that surrounds this condition?
ROMO-NAVA: I think the answer to that belongs to both of those questions because I think that a great part of the stigma towards psychiatric disorders is it’s largely driven by the human response to the unknown. One of the best ways on which we can help decrease or eliminate stigma is through information. And this involves information on several levels. At the level of society and the level of the general population. It would be with information to what is already known regarding the causes, the symptoms, the prognosis, the evolution, the available treatments for each of the psychiatric disorders and particularly, for the schizophrenia spectrum disorders, which if there’s little information about the symptoms, then there’s room for prejudice or there’s room to misinterpret the meaning or what the symptoms indicate. Sometimes if we are able to describe that that idea is part of the symptoms, that that behavior is part of the symptoms, that there’s several treatment options that can help, then that helps the patient talk about control of those symptoms or decrease the severity of those symptoms and also helps with the dynamic of the family and those around the patient. In that sense, the stigma can be greatly reduced through information of conducting more research to move more and then be able to inform more about these symptoms to the overall population.
Are you ever cured if you’re diagnosed with schizophrenia?
ROMO-NAVA: Well, at the moment, there’s no definitive cure. We can talk about treatments to decrease all of these aspects of some of the different conditions, but that’s certainly something that we keep working for, to find new options and new and better treatments for all of these conditions.
Is there anything else you would like people to know?
ROMO-NAVA: Perhaps that our study is still recruiting individuals. If anyone is interested, they can fill out a prescreening questionnaire on our webpage. It’s www.lcoh.info. This is a study that we are now at 70% of our recruitment goal and we expect to complete recruitment this year. We would like 20 individuals that are not currently on medication and are 18 to 55 years old.
Interview conducted by Ivanhoe Broadcast News.
END OF INTERVIEW
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KATIE PENCE
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