Notes
Outline
Slide 1
STAR*D: Lead Investigators
University of Texas South-western Medical Center
A.J. Rush, MD
M.H. Trivedi, MD
Massachusetts General Hospital
M. Fava, MD
A. Nierenberg, MD
J.F. Rosenbaum, MD
University of Pittsburgh Medical Center
M. Thase, MD
R. Howland, MD
D.J. Kupfer, MD
S. Wisniewski, PhD
Columbia University College of Physicians & Surgeons
F. Quitkin, MD
H. Sackeim, PhD
P. McGrath, MD
STAR*D: Objectives (1)
Slide 4
STAR*D: Multiple Outcomes
STAR*D Inclusion Criteria
STAR*D LEVELS
Level 1: CIT
Level 2:
Switch: BUP, CT, SER, VEN
Augment: BUP, BUS, CT
Level 3:
Switch: NOR, MIR
Augment: Li, THY
Level 4:
Switch: TCP, VEN + MIR
STAR*D (Study Overview)
N = 4,000
MDD, nonpsychotic
Specialty and primary care
Almost all comorbidities
Research outcomes separated from clinical practice
12 weeks/Level
1-year follow-up
Questions
What are the best options for Levels 2, 3, 4, etc.?
Which options are most acceptable?
Do pretreatment indicators help in selecting among treatment(s)?
What is an adequate trial (dose, duration)?
Are guidelines (protocols) more effective
(? less costly) than TAU?
How long do acute phase benefits last?
Are particular pharmacotheoretical notions valid?
Slide 10
STAR*D - Defining Evidence for Protocols (LEVEL 2)
STAR*D - Defining Evidence for Protocols (LEVEL 3)
STAR*D - Defining Evidence for Protocols (LEVEL 4)
STAR   D: Summary
5-year study
12 to 14 Regional Sites
More than 72 clinicians
Independent evaluators
4,000 depressed patients treated openly
2,000 likely to not remit after first treatment
Randomization at Levels 2-4 only to treatment options acceptable to patient participants
Evaluation of outcomes in multiple domains