Frequently Asked Questions about the STAR*D Study
STAR*D is one of the largest, independent and most robust studies ever undertaken by the National Institute of Mental Health to examine the effectiveness of a variety of medications in the treatment of depression. It is considered one of the “gold standards” in the world of treatment research for depression and came to a number of important (and in some cases, surprising) conclusions about depression medication treatment.
The conclusions from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study were published in the American Journal of Psychiatry on November 1, 2006. An overall assessment of the nation’s largest real-world study of treatment-resistant depression suggests that a patient with persistent depression can get well after trying several treatment strategies, but his or her odds of beating the depression diminish as additional treatment strategies are needed. Below you will find commonly asked questions and their answers about this ground-breaking study.
1. What were the goals of the STAR*D trial?
A. The overall goal of the STAR*D trial was to assess the effectiveness of depression treatments in patients diagnosed with major depressive disorder, in both primary and specialty care settings. It is the largest and longest study ever conducted to evaluate depression treatment.
Each of the four levels of the study tested a different medication or medication combination. The primary goal of each level was to determine if the treatment used during that level could adequately treat participants’ major depressive disorder (MDD). Those who did not become symptom-free could proceed to the next level of treatment.
The design of the STAR*D study reflects what is done in clinical practice because it allowed study participants to choose certain treatment strategies most acceptable to them and limited the randomization of each participant only to his/her range of acceptable treatment strategies. No prior studies have evaluated the different treatment strategies in broadly defined participant groups treated in diverse care settings.
2. Who participated in the study?
A. Over a seven-year period, the study enrolled 4,041 outpatients, ages 18-75 years, from 41 clinical sites around the country, which included both specialty care settings and primary medical care settings. Participants represented a broad range of ethnic and socioeconomic groups. All participants were diagnosed with MDD and were already seeking care at one of these sites. No media advertisements were used to recruit participants. Instead, they were referred to the trial by their doctors.
So that results could be generalized to a broad group of real-world patients, most adults with MDD were eligible. People were not eligible for the study if they had not tolerated or did not get well with one or more of the treatments that were part of the first two STAR*D treatment steps, or if a STAR*D treatment could not be safely used because of another medical condition or because they were taking certain other medications. In addition, people with substance abuse disorders that required detoxification, anorexia or bulimia, or obsessive compulsive disorder were not eligible for the study because they required treatments that were not part of STAR*D.
Of the initial 4,041 participants, 1,165 were excluded because they either did not meet the study requirements of having “at least moderate” depression (based on a rating scale used in the study) or they chose not to participate. Thus, 2,876 “evaluable” people were included in level 1 results. Level 2 results include 1,439 people who did not become symptom-free in level 1 and chose to continue. Level 3 results include 377 people, and Level 4 results include 142 people.