Method
How many total patients were included in this study?
1167
What weeks were patients assessed at?
0 weeks (baseline)
4 w
8 w
12 w
24 w
Outcomes were measured at week ______.
8
What are clinical considerations?
The states rationale for a medication's classification and offer treatment adjustments if a clinician desires to use the selected medication.
How is this study blinded, since the doctor had to know whether they were using the GeneSight test or not?
Blinded for two groups- patients and raters. All patients received the buccal swab.
How many study sites were included?
60
-20 academic
-40 community
What were the patient requirements to be included in the study? (3)
-over 18
-diagnosed with MDD
-failed at least one psychotropic medication in the current depressive episode
*excluded if suicidal, co-occuring psychiatric or cognitive disorders, and or unstable significant medical conditions
The GeneSight arm experienced a _____% relative improvement in response rates at week 8 compared to TAU. Was this statistically significant?
30% ; yes
What are pharmacodynamic genes?
what the drugs do to the body
What are the secondary outcomes (2)?
Response and Remission rates
What was the average number of med failures across the study population?
3.5
The GeneSight Psychotropic effect on response and remission rates continued to grow after unblinding and up to _____months.
6 months (durability)
The GeneSight arm experienced a _____% relative improvement in remission rates at week 8 compared to TAU. Was this statistically significant?
50% ; yes
What are pharmacokinetic genes?
What the body does with the drug
What license plate is Claire currently on?
North Carolina
Why is the GUIDED study different than other prior clinical trials?
Psychiatry + Primary Care***
What are the three levels of Gene-drug interactions
- no gene drug interaction (green use as directed)
- moderate GDI (yellow use with caution)
- severe GDI (red use with extreme caution)
The GeneSight arm experienced an ___% relative improvement in symptoms at week 8 compared to TAU. Was this statistically significant?
11% ; no
What is the difference between a genotype and a phenotype
Phenotype - an expression of a genotype, the observable trait
Name 3 limitations to the GUIDED study
-Mostly Caucasian
-treating clinicians not blinded
-Study did not include patients with mild depression, may not be able to generalize to mild depression patients.
Who were the principal investigators of the GUIDED study? And which University are they from?
-Dr. John Greden & Dr. Sagar Parikh
-University of Michigan
What does GUIDED stand for
Genomics Used to Improve Depression Decisions
What did the congruency data focus on and how many of the population?
Only patients that came in on the red bin medication and moved from yellow/ green. (220/1167)
What are the four types of metabolizers
Ultrarapid
Extensive (normal)
intermediate
poor
When looking at patients who were on a red category medication entering the study, when clinicians switched to green or yellow, category medications patients saw a:
___% improvement in remission rates
___% improvement in response rates
___% increase in symptom improvement at week 8 vs. those who remained on red.
153% improvement in remission rates
71% improvement in response rates
59% increase in symptom improvement