Documente Academic
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Documente Cultură
By
Ahmad Al-Dabbas
Resident in Psychiatry
STAR*D
• The STAR*D trial is the largest open-label, pragmatic
trial that has been undertaken to examine the
treatment of major depressive disorder.
• At a cost of US$35 million over 6 years (2000-2006),
STAR*D sought to test the effectiveness both of
pharmacotherapy and of cognitive therapy, and to
ascertain whether certain treatments are more
optimal after one or more failed trials.
• It attempts to examine typical patients in a real-
world setting.
STAR*D
STAR*D differs from standard
RCTs in 6 key ways
STAR*D
1. Broad inclusion criteria with few exclusion criteria:
• Commonly, RCTs in the unipolar major depression
literature recruit patients who are carefully selected
to have minimal psychiatric, medical, or substance
comorbidities. The result is that patients in these
RCTs increasingly represent only a small subset of
patients routinely treated by psychiatrists in
everyday practice
• In contrast, the STAR*D trial aimed to be
generalizable to clinicians by employing minimal
exclusion criteria
STAR*D
2. The integration of patient choice:
• Allowing patients to be involved in the selection of
their treatments may lead to better outcomes by
contributing to the therapeutic alliance and the
sense of belief in, or ownership of, the treatment.
• Patients were divided into groups based on the
treatments that they are willing to accept, thereby
permitting randomized comparisons while
simultaneously allowing patients to make choices
based on their preferences.
STAR*D
3. Open-label treatment:
• STAR*D deals with this issue by making treatments
known to both the patient and the treating
physician, as in normal clinical practice, while
simultaneously minimizing bias by keeping outcome
assessors, who are independent of the treatment
team, blinded to the therapy.
STAR*D
4. The use of measurement-based care:
• Symptoms and side effects were rated at each visit
and clinicians would receive automated feedback to
ensure adequate and safe treatments.
37%
Principal Outcomes
• Rates of remission and response were much higher
in Levels 1 and 2 than in the latter 2 levels.