STAR*D is a study which is often talked about in psychiatry. At TMS Augusta we find it informative, interesting to discuss with people, and relevant to people considering their treatment options. The study was completed in 2006, and the results became available in 2008, but STAR*D is still news to most people.
Important information about why it’s so important to treat depression to remission was discovered by STAR*D. This information is towards the bottom of this article, and boldly underlined. It’s still news to almost everyone; unfortunately, this includes far too many of your doctors!
The long name for STAR*D is Sequenced Treatment Alternatives to Relieve Depression. Over 4,000 clinically depressed outpatients were studied at 23 psychiatric and 18 primary care sites. Thus, STAR*D was a big study which makes it more meaningful. It was not however double blinded, so both patients and researchers knew which medications were being used. In most true research, both researchers and research subjects are supposed to be in the dark about what the treatment is, but here that wasn’t the case. In a sense, STAR*D was perhaps more like the real world practice of medicine because everybody knew what was going on.
The study measured three sorts of clinical outcomes in studying people with major depressive disorder (MDD).
The best outcome was what is called remission. This means that the treatment works so well that the patient has no more evidence of depression than a person who is not depressed. In other words, a patient who is in remission may still have some symptoms of depression, but they don’t have any more symptoms of depression than a person who has never felt depressed in their life. In remission, any remaining symptoms are so minor that the person feels well. A patient in remission may still be receiving medication. Remission doesn’t mean the person is cured, but they’re vastly better.
A less meaningful reduction in depressive symptoms is called a response. Patients with this outcome are 50% better, but they are not well enough where they should be considered well. They don’t feel well, and clinicians using standardized rating instruments would not rate them as well. A doctor not using standardized rating instruments might make the mistake of thinking a patient showing this sort of partial response was well enough, but they’d be wrong.
The standard of care in treating depression is to always be satisfied only when remission is achieved.
The third outcome was a clinically insignificant result. Treatment didn’t work well enough to be at all meaningful. Fewer than 50% of the symptoms improved. Maybe something was happening, but it wasn’t enough to even count.
If you want to read exactly how the study was done, and see exactly what happened at each of the 4 treatment levels, there are many good review articles outlining in detail how STAR*D was designed, what the response and remission rates were with all the various treatments, etc. For some people this information is incredibly interesting. For others it’s tedious, and more than they want to know. Here are a couple of links to pretty good articles (Wikipedia & NIMH) on STAR*D for those who are interested. Many more articles are easy to find if you’re interested, but let’s cut to the chase, and discuss what we believe is the most important information to come out of STAR*D.
Pay attention as you read these articles to the third outcome with medicines – a clinically insignificant result. Sometimes the antidepressant medications work very well, but oftentimes they don’t work well at all. As defined by STAR*D, a less than 50% reduction of symptoms doesn’t even count as a significant result.
For many psychiatrists, STAR*D established a new standard of care: In STAR*D, the clinically significant, and overwhelming important outcome measure was a remission of depressive symptoms—becoming essentially symptom-free.
This outcome was selected because people who reach this goal generally function better socially and at work, and have a better chance of staying well than do people who only achieve a response but not a remission. STAR*D made the case for remission being necessary in order that folks be able to feel well enough, and function well, and also demonstrated that remission is important because it increases the chances that a person will stay well.
At the risk of being repetitive, it’s important to say it again: Treating depression successfully means achieving remission if that is at all possible.
STAR*D seemed to nail down the need to use medicines in high enough doses, too. However, we now know that sometimes a lower dose is more effective than a higher dose, and why (that will be the subject of a future article on this website).
The bottom line summary of the STAR*D study is this:
An overall analysis of the STAR*D results indicates that patients with difficult-to-treat depression can get well after trying several treatment strategies, but the odds of beating the depression diminish with every additional treatment strategy needed.* In addition, those who become symptom-free have a better chance of remaining well than those who experience only symptom improvement. And those who need to undergo several treatment steps before they become symptom-free are more likely to relapse during the follow-up period. Those who required more treatment levels tended to have more severe depressive symptoms and more co-existing psychiatric and general medical problems at the beginning of the study than those who became well after just one treatment level.
Because of STAR*D, for the first time, doctors and people with depression now have extensive data on antidepressant treatments from a federally funded, large-scale, long-term study directly comparing treatment strategies. It’s not a perfect study, but it is very meaningful, and it remains very important to TMS Augusta, and to our patients.
*STAR*D did not study TMS. When they’re talking about treatment strategies they mean antidepressant medications. TMS increases the odds of beating the depression. TMS is typically used when other treatments have already failed. Transcranial magnetic stimulation is known to have a far better chance of producing remission than trying another antidepressant.