Hello, friends.
About a week ago, I was at the Christian Counseling Center for my weekly session with Sherry. Next to a stack of magazines, there was a new notice:
"Pine Rest is sponsoring a clinical research study for clients who have a diagnosis of Major Depressive Disorder (MDD) and who have not experienced relief through medication or therapy. Research is now being conducted to examine the efficacy and safety of Sirukumab, which is also being studied as a treatment for rheumatoid arthritis. If you have any questions or have interest in participating in this study, please call our research coordinator at (phone number)."
(That's the gist of what the notice said. It was a lot longer and had a lot more description and screening information. I would have wasted both my time and yours in retyping all of it.)
I mulled that study description over in my head for a week. What I should have done was asked Sherry about it right away at our session, since I had just read it and it piqued my interest. I had always thought that my diagnosis was more along the lines of Persistent Despressive Disorder instead of MDD, though, so it didn't cross my mind to ask her about the study.
Over the weekend, I kept thinking about it and I did some of my own research. What was Sirukumab? Where else was this study being conducted? Is this drug approved and safe and legit? Could I maybe get paid if I qualify to participate? Would I have to stop going to therapy? Thank goodness this sort of activity is all federally regulated and monitored, so there is an entire .gov website devoted to clinical trials happening in the US. I'll get into what the study is all about in just a little bit.
During the following week, I corresponded with the research coordinator at Pine Rest to tell her that I was interested and to ask for some more information to see if I qualify. I opted to do some pre-screening questions over the phone, but we couldn't get a solid half-hour on the phone til Friday because I had parent-teacher conferences and professional development during the second half of the week. Plus, I wanted to bring it up to Sherry before making any appointments. On Thursday, I had counseling again, so I got some more information and signed a consent form to be contacted about participation (just in case, I think, since I had already been in contact with the coordinator).
Then on Friday, after PD and some lengthy conversations with parents, I was able to get on the horn with Pine Rest for the pre-screening. She asked me a bunch of questions about my health, my age, my depression symptoms, comorbid conditions (i.e., my anxiety), and logistics of participating for the full six months the study would require (i.e., could I come to Pine Rest's main campus for appointments, could I take off of work if needed to accommodate appointments that might last up to five hours, would I be living in the area for the next six months, etc.). After answering all of her questions, she told me that as of right now, I seem to be a great candidate for this study. The only concern is whether my depression is "severe" enough. Anyone reading this who has depression will understand why I put that in quotation marks - one's experience of depression (and its severity) will fluctuate from day to day or season to season. In my case, the question is whether I am currently in a "major depressive episode." As in, is my depression worse right now than my baseline depression? Honestly, I couldn't begin to tell you, since what on earth is my baseline for depression? It's not "no depression symptoms present," since I haven't experienced that since I was 18. And if history is any indicator, my "major depressive episodes" tend to coincide with fall and winter, which means that I may be (and definitely probably am) heading into one right now. Plus, how are we gauging my symptoms? Symptoms with antidepressants + therapy? Symptoms with antidepressants without therapy? Symptoms with neither? It's too hard to evaluate myself on those terms since I've taken meds nonstop for four years and gone to therapy every week for three years.
Do you see why it takes so long for new treatments to hit the market?
Anyway, I will go to the study clinic on Thursday morning for official screening and, if all goes well, the initial contact session. Here's what the study entails, and some Research Methods 101 for those of you who are not familiar with how this sort of thing works:
- Participants will receive either an injection of Sirukumab, the treatment under investigation, or an injection of placebo (so that the doctors can determine if there is any clear benefit experienced by the people getting the Sirukumab). The participants won't know which injection they get, and neither will the study doctors, so that the results will be as free as possible from bias and unconscious interpretation. In studying a condition like depression, this is extra extra super extra important, as reporting of symptoms is entirely subjective - there's no blood test or exam to determine if my "level of depression" has gone down. If I think I'm getting the Sirukumab, I may unconsciously skew my reporting of symptoms by describing them as less severe than they may actually be. In other words, I may want so badly for this drug to work that I try to prove to myself and the clinicians that it is working. I'm hoping that my background understanding of research and my long-term experience of depression will help me to evaluate my symptoms accurately.
- Participants will get bloodwork done on a regular basis to see if the Sirukumab is having an effect on the thing they want it to have an effect on. From what I understand, Sirukumab works like an anti-inflammatory drug - something is signalling the body's immune (?) system to have a certain response, indicated by inflammation. And we're talking inflammation on a cellular level, not like inflammation of the lips or ankles. If only it were that visible. Introducing an anti-inflammatory tells the system to cool it, stop inflaming, nothing to see here. Sirukumab was first developed as a treatment for rheumatoid arthritis, which is all about inflammation, but research conducted recently claims to show a link between inflammation markers in the blood and experience of symptoms of depression. That is, the more "severe" the depression, the more likely it is that the person also has high levels of these markers. This study is meant to explore this link and see if an anti-inflammatory that is specifically designed to cooperate with antidepressants (many AIs are not) will lessen the severity of depression symptoms. Antidepressants have no effect on inflammation, so a positive outcome from this study could revolutionize the treatment of long-term depression (like I have) that doesn't go away with just antidepressants.
- Participants get three injections over 12 weeks, with appointments in between the injections as well, and then there are 5 or 6 appointments over 14 weeks after the set of injections is completed. This is probably to gauge response to the injection over time. To compensate for all the driving and time spent in the clinic, participants get a $50 Meijer card for every appointment completed. Lucky for me, I live in the Grand Rapids area and Pine Rest is not that far away from me. BLAMMO.
I really really really really hope that they will select me to participate in this. It's fascinating to me. While I have (more or less) come to terms with the idea that my depression may be a lifelong struggle, I still hold my candle of hope that new discoveries will be made that lessen the symptoms and severity of depression. This sounds like it could do that, since it's an entirely different direction for research of depression treatment. I honestly don't even care if I get the placebo. I just want to be a part of something like this. I want to put my depression to work for me, instead of working against me, like it seems to do a lot of the time. If it works and becomes a thing, I think it would be so cool to be able to say down the line, "hey, I was part of the clinical trials for that drug!"
This is going to sound like a very bizarre request, but would you all pray that my depression meets the criteria for "severity"? Odd, I know, to pray that a disease is bad enough instead of praying for it to get better. I just hope that I can convey to the interviewer that mine is the depression they are looking for - it may not prevent me from going to work or class or getting things done, but it is still with me every single day, in spite of meds and therapy. In fact, I think it would be a LOT worse without therapy. Maybe they can use my description of how I felt before starting therapy. Compared to now, that was pretty severe.
Hopefully, I will be able to tell you all on Thursday afternoon that I was accepted to the study! Until then, more middle school drama and joys of adolescence. I'll have to write about that sometime. That could keep me busy writing for weeks.
No comments:
Post a Comment