Dr Shock stayed out of the discussions about the STAR*D trials. The choice of treatments was absolutely not evidence based and the results could never by generalized to Europe or The Netherlands for that matter. A recent publication in Evidence Based Mental Health Care summarizes the difficulties of the STAR*D trials. If you need more information about this trial please visit the website: Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study
Difficulties with STAR*D
- There was no placebo arm in level one of the trial. Primary care physicians offer support, explanation and time (‘‘wait and see’’) as important interventions in the management of low mood. This makes generalisability difficult for patients in primary care. In this trial about a third of patients were recruited from primary care and they have been offered the option of a wait and see or a placebo option. Moreover, I am an advocate for placebo controlled trials. You can read in this post for the reasons why: 7 Reasons for placebo controlled trials in depression.
- To consent to inclusion in the trial participants had to find prescription of an antidepressant acceptable. This excludes those who would rather have psychotherapy as treatment option and probably explains why so few people chose to be randomised to a psychotherapy option in level two of the trial.
- The choice of strategies appears hard to justify. Why choose buproprion and buspirone as initial augmentation strategies when there appears better evidence for augmentation with lithium? For other and better options as well as a better treatment algorithm read: 9 steps for treatment resistant depression
- The lead investigators had significant relationships with the makers of the drugs used in the study.
- Because of the diverse range of healthcare providers, the relative lack of primary care and the difficulty accessing care by people without insurance it is hard to generalise the results into non-US health settings.
- The definition of treatment resistance in this trial is to be viewed upon as pseudoresistant depression as discussed in a post: 5 Features of pseudoresistant depression. Moreover, no one knows what treatment resistant depression really is: 6 different definitions of treatment resistant depression.
The STAR*D trial may be the 300 lb gorilla of clinical trials but disappointingly it only sheds a little light on how to manage depression in clinical practice.
S. Hatcher (2008). The STAR*D trial: the 300 lb gorilla is in the room, but does it block all the light? Evidence-Based Mental Health, 11 (4), 97-99 DOI: 10.1136/ebmh.11.4.97